- ‘More and more on the move’. Record number of migrant children in Latin America and Caribbean, UN warns CNN
- Children migrating through Latin America, the Caribbean reach record highs, UN says Fox News
- A record numbers of children are on the move through Latin America and the Caribbean, UNICEF says The Associated Press
- Unicef sounds alarm as record numbers of children cross dangerous Darién Gap The Guardian
- Migrant kids are moving through Latin America and the Caribbean in record numbers, U.N. says Miami Herald
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Tag Archives: Latin
Music streams for 2023 hit 1 trillion in record time. Latin and K-pop artists are big reasons why – The Associated Press
- Music streams for 2023 hit 1 trillion in record time. Latin and K-pop artists are big reasons why The Associated Press
- Vinyl Sales Up 22% in U.S. in First Half of 2023, Per Luminate’s Midyear Music Report (EXCLUSIVE) Variety
- On-demand song streams grew 15% to 713.5bn in the US in H1… and 5 other key stats from Luminate’s midyear Music Business Worldwide
- US vinyl sales up 21.7% for first half of 2023, report finds The Guardian
- Music streams top 1 trillion at the fastest pace yet, reflecting more global industry, report finds CTV News
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American unveils 2 new routes, 23 upgraded flights in largest-ever Caribbean and Latin America schedule – The Points Guy
- American unveils 2 new routes, 23 upgraded flights in largest-ever Caribbean and Latin America schedule The Points Guy
- American Airlines adding nonstop service to Cancun from Cincinnati The Cincinnati Enquirer
- White sand and warm weather: American Airlines announces largest-ever winter schedule to the Caribbean and Latin America American Airlines Newsroom
- American Airlines Announces Largest-Ever Winter Schedule To Latin America And The Caribbean Simple Flying
- American Airlines expands Charlotte winter flights to these warmer destinations Charlotte Observer
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Former Peruvian President Castillo’s impeachment: a warning sign to Latin America’s left
Peru’s recent impeachment of President Pedro Castillo represents an opportunity for the U.S. to reset its geopolitical and economic relations with one of its most important allies in Latin America. Peru has enjoyed an impressive track record of economic growth based on free-market reforms, and a particularly close relationship with the U.S.
However, Castillo’s election posed a threat to that relationship, as his Marxist-oriented ideology threatened the economy, while his foreign policy signaled a major shift towards anti-American interests.
“Castillo posed an institutional menace on an altogether different scale,” Daniel Raisbeck, a Latin American political analyst at the Cato Institute, told Fox News Digital. “To begin with, his party’s program for the 2021 election included numerous measures that explicitly sought to violate the constitution’s unequivocal safeguards for private property, which it declares ‘inviolable.'”
Observers say Castillo’s impeachment by Peru’s Congress this week sent a damning message to Latin America’s left that attempts to play fast and loose with the rules will be met with a stern institutional response.
PERU BOOTS PRESIDENT OVER ATTEMPT TO DISSOLVE CONGRESS, NEW LEADER SWORN IN
By threatening to shut down Congress, rule by decree and rewrite the Constitution, Castillo emulated his Venezuelan counterpart Nicolas Maduro, who used similar maneuvers to effectively sideline the National Assembly, and then used a hand-picked constituent assembly to ram through a new Constitution, granting him near-absolute power. The Peruvian people and its institutions sent a resounding message calling for respect for the rule of law and adherence to Constitutional order.
Castillo hailed from the Peru Libre, an openly Marxist political party, and took inspiration from such leaders as Fidel Castro and Vladimir Lenin. To say that business leaders and investors were concerned with the prospect of a Castillo mandate would be an understatement.
Raisbeck said that Castillo was a clear and present danger to the Peruvian economy. “The constitution also guarantees free enterprise, foreign investment, and press freedom. Castillo’s platform, on the other hand, set out an agenda of nationalizing the mining sector and other major industries, expropriating land and getting rid of Peru’s successful private pension system,” he explained.
As Peru’s Congress proceeded on Wednesday with a third impeachment attempt, Castillo took to national television to announce its dissolution, pledging to call for a new Constitutional assembly and temporarily rule by decree in a move emulating his Venezuelan counterpart Maduro.
However, Castillo appeared to have badly miscalculated his levels of institutional support, and his surprise announcement prompted a massive resignation on the part of his cabinet and a stern call from the Attorney General to respect the Constitutional order.
PERU’S PRESIDENT DISSOLVES CONGRESS AHEAD OF 3RD REMOVAL TRY
Finally, in swift succession, his own vice president, Dina Boluarte, publicly condemned Castillo’s actions:
“I reject the decision by Pedro Castillo to perpetrate a rupture in the Constitutional order by closing Congress. This represents a coup, and aggravates the institutional political crisis that Peruvian society can only overcome by strictly adhering to the law.”
Peru has enjoyed an impressive track record of economic growth based on free-market-oriented reforms. Yet, the election of the far-left Castillo followed a regional trend, as the Latin American left has enjoyed a powerful resurgence over the last few years, winning the vast majority of important elections, albeit it often by narrow margins, racking up important victories in Mexico, Brazil, Argentina, Chile and Colombia.
Following Lula da Silva’s narrow victory in Brazil’s presidential election in October, Argentine Congressman Javier Milei, a frequent critic of the region’s left, tweeted out a meme deeming Latin America to be the USSR — the “Union of South American Socialist Republics.”
Castillo’s desperate attempt to cling to power echoes similar tactics previously used by Latin American despots: attempting to shut down opposition bodies, ruling by decree and calling for new “constituent assemblies” to rewrite the Constitution in their favor.
Castillo’s short tenure as president featured numerous corruption investigations involving charges of graft and self-dealing. More serious charges have now emerged against him and close allies alleging ties to the Shining Path, a Marxist guerrilla group based in the south of Peru, which once controlled vast swaths of the country.
COLOMBIA ELECTS FORMER REBEL GUSTAVO PETRO TO BECOME COUNTRY’S FIRST LEFTIST PRESIDENT
Castillo was arrested late Wednesday afternoon in Lima, and charged with rebellion and breaking the Constitutional order. His current whereabouts remain unclear. Mexico’s foreign minister recently announced that they are considering an offer of asylum to the ex-president.
Rossy Saavedra Medina, who lives in the Lima neighborhood of Magdalena del Mar, called on the new president to focus on the economy. “The economy has to get back to normal now… in the last few months, it has been the poor who have suffered the most,” she told Fox News Digital.
Juan Antonio Castro, a retired math professor and dual U.S.-Peruvian citizen, told Fox News Digital that Castillo “seemed to be a corrupt individual trying to enrich himself and his family… Why do people vote for these candidates? It’s the same thing we saw happening in Venezuela.”
Protesters had gathered in various points in Lima to protest against Castillo’s arrest. Some of the protests at times turning violent as they clashed with police outside the Congress building.
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Interim president Boluarte, who hails from the southern region of Apurimac, is viewed by observers as something of a blank slate, and it remains unclear how she intends to govern. While she was elected on the ticket of Castillo’s Peru Libre Party, which espouses Marxist origins, she was later expelled from the organization by party bosses when she declared that she did not plan to adhere to the party’s doctrine.
Angela Álvarez crowned best new artist at Latin Grammys – aged 95 | Music
Don’t ever tell Angela Álvarez it’s too late for dreams to come true – the 95-year-old just brought home a Latin Grammy for best new artist, becoming the award show’s eldest winner ever.
The Cuban American musician’s crowning moment came after decades of writing songs but performing them only for friends and family – until, at the age of 90, she went to the Avalon, the historic Hollywood nightclub, and gave her first concert.
Her grandson, Carlos, eventually recorded her songs on to an album with the help of the actor and fellow Cuban who hosted that concert: Andy García. The self-titled record came out last year, setting up her nomination at Thursday’s edition of the Latin Grammys and a shared win with Silvana Estrada.
“To those who have yet to make their dreams come true, know that although life is hard, there’s always a way out and with faith and love everything can be achieved,” Álvarez said in her acceptance speech.
It’s hard to overstate some of the obstacles she had to overcome to make her mark on the music industry.
Growing up in pre-revolutionary Cuba, her father and grandfather forbade her from pursuing her love of music. But she wrote songs in secret, as she got married and had children.
Then the Cuban revolution that led to decades of leadership under Fidel Castro unfolded, and Álvarez made what she has called her life’s most difficult decision: sending her four children to the United States. They went as part of Operation Pedro Pan, which saw more than 14,000 children sent to the US during Cuba’s revolutionary era between 1960 and 1962.
Álvarez eventually joined her children in the US, delayed by paperwork problems, the Miami Herald reported. The family settled in the capital of Louisiana, Baton Rouge. But life continued testing her faith – she lost her husband and her only daughter to cancer.
Nonetheless, she kept up with her songwriting and singing, mostly sharing her work only with those closest to her.
That changed when she agreed to take part in a documentary named Miss Angela, which chronicles her upbringing in Cuba and her preparing for her first concert at the Avalon. The documentary captured the moment that her host García – the Academy Award nominee – introduced himself and joked: “I heard you needed a bongo player.”
García, whom Álvarez described as her hero in Miss Angela, later gave her a role in the Father of the Bride remake he starred in. In the movie, she sings the Cuban musical standard Quiéreme Mucho, which means love me a lot.
Álvarez’s composer and producer grandson, Carlos, gave her the idea to go out to Los Angeles and record her self-titled debut album, People.com reported, citing the music publication Billboard.
“I called her up and I said, ‘Nana, do you want to do this?’ First she said [in Spanish], ‘I’m not going to Los Angeles! For what?’ And I say, ‘To record your album!’ And she’s like, ‘OK, I’m there!’”
After winning best new artist alongside Estrada at the 23rd annual Latin Grammys on Thursday, Álvarez encouraged all dreamers to keep their wildest hopes burning bright as she basked in front of a standing ovation at the Mandalay Bay Michelob Arena in Las Vegas.
“There are people who give up, but I did not give up – I always fought,” she said during her speech, which she dedicated to Cuba, according to the Los Angeles Times. “I promise you – it’s never too late.”
Angela Álvarez, 95, wins best new artist Latin Grammy in a history-making tie
CNN
—
Angela Álvarez made Latin Grammy history on Thursday by winning the award for best new artist at age 95.
The singer tied in the category with musician and songwriter Silvana Estrada, but she had already set a record going into the event with her nomination as the oldest musician ever nominated in the category.
“I want to dedicate this award to God and to my beloved country, Cuba, which I will never be able to forget,” Álvarez said accepting her award on stage at the Latin Grammys in Las Vegas.
The Cuban-native’s passion for music began in her youth. She was discouraged from pursuing a career in music by her father but found joy performing for her family. The mother of four, grandmother of nine and the great-grandmother of 15 immigrated to the United States in the 1960s, according to Billboard.
Over the years, she sang for her family about her life and developed a collection of songs she composed. At the encouragement and support of her grandson, she eventually recorded and released collection of her songs in 2021.
The Latin Grammy nomination came as a surprise to her, Álvarez told CNN en Español last month.
“I felt very, very proud to be able to tell my story, to touch people who have probably gone through the same or more than what I have gone through. There are people who give up, but I did not give up. I always fought,” she said.
Álvarez concluded her speech on Thursday with words of inspiration.
“To those who have not fulfilled their dream, although life is difficult, there is always a way out and with faith and love you can achieve it, I promise you,” Álvarez said. “It’s never too late.”
Biden unveils new Latin America economic plan at reboot summit dogged by dissent
LOS ANGELES, June 8 (Reuters) – President Joe Biden announced on Wednesday a proposed new U.S. economic partnership with Latin America aimed at countering China’s growing clout as he kicked off a regional summit marred by discord and snubs over the guest list.
Hosting the Summit of the Americas in Los Angeles, Biden sought to assure the assembled leaders about his administration’s commitment to the region despite nagging concerns that Washington, at times, is still trying to dictate to its poorer southern neighbors.
The line-up of visiting heads of state and government in attendance was thinned down to 21 after Biden excluded Cuba, Venezuela and Nicaragua, prompting Mexican President Andres Manuel Lopez Obrador and several other leaders to stay away in protest.
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“We have to invest in making sure our trade is sustainable and responsible in creating supply chains that are more resilient, more secure and more sustainable,” Biden told a gala opening ceremony.
Biden is seeking to present Latin American countries with an alternative to China that calls for increased U.S. economic engagement, including more investment and building on existing trade deals.
However, his “Americas Partnership for Economic Prosperity,” which still appears to be a work in progress, stops short of offering tariff relief and, according to a senior administration official, will initially focus on “like-minded partners” that already have U.S. trade accords. Negotiations are expected to begin in early fall, the official added.
Biden outlined his plan as he launched the summit, which was conceived as a platform to showcase U.S. leadership in reviving Latin American economies and tackling record levels of irregular migration at the U.S.-Mexico border.
But his agenda has been undermined by the partial boycott by leaders upset at Washington’s decision to cut out its main leftist antagonists in the region.
As a result, Biden found himself welcoming a larger-than-normal contingent of foreign ministers sitting in for their national leaders as the arriving dignitaries walked one-by-one up a red carpet flanked by a military honor guard.
U.S. officials hope the summit and a parallel gathering of business executives can pave the way for greater cooperation as governments grappling with higher inflation work to bring supply chains stretched by the COVID-19 pandemic closer to home.
Biden also used his speech to preview a summit declaration on migration to be rolled out on Friday, calling it “a ground-breaking, integrated new approach” with shared responsibility across the hemisphere. But he provided few specifics.
Even as Biden deals with priorities such as mass shootings, high inflation and the Ukraine war, the U.S. official said the president is seeking to press the administration’s competitive goals against China with the launch of the new partnership for the region.
The U.S. plan also proposes to revitalize the Inter-American Development Bank and create clean energy jobs
Still, the administration appeared to be moving cautiously, mindful that an initiative that promotes jobs abroad could face U.S. protectionist pushback.
CHINA’S CHALLENGE
The challenge from China is clearly a major consideration.
China has widened the gap on the United States in trade terms in large parts of Latin America since Biden came into office in January 2021, data show.
An exclusive Reuters analysis of U.N. trade data from 2015-2021 shows that outside of Mexico, the top U.S. trade partner, China has overtaken the United States in Latin America and increased its advantage last year. read more
“The best antidote to China’s inroads in the region is to ensure that we are forwarding our own affirmative vision for the region economically,” the administration official said.
Biden’s aides have framed the summit as an opportunity for the United States to reassert its leadership in Latin America after years of comparative neglect under his predecessor Donald Trump.
But diplomatic tensions broke into the open this week when Washington opted not to invite the three countries it says violate human rights and democratic values.
Rebuffed in his demand that all countries must be invited, Lopez Obrador said he would stay away, deflecting attention from the U.S. administration’s goals and toward regional divisions.
Biden’s national security adviser Jake Sullivan told reporters the choice by some leaders not to attend reflected their own “idiosyncratic decisions” and that substantive work would still be accomplished.
Cuban President Miguel Diaz-Canel said the United States lacked “moral authority” to lecture on democracy and thanked Lopez Obrador for his “solidarity.”
The leaders of Guatemala and Honduras, two of the countries that send most migrants to the United States, also stayed home, raising questions about the significance of the coming joint migration declaration.
Still, leaders from more than 20 countries, including Canada, Brazil and Argentina, are attending the summit, hosted by the United States for the first time since its inaugural session in 1994.
Biden will use a meeting on Thursday with Brazilian President Jair Bolsonaro to talk about climate change and will also discuss the topic of “open, transparent and democratic elections” in Brazil. read more
Bolsonaro, a populist admirer of Trump who has had chilly relations with Biden, has raised doubts about Brazil’s voting system, without providing evidence, ahead of October elections that opinion polls show him losing to leftist rival Luiz Inacio Lula da Silva.
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Reporting by Trevor Hunnicutt, Daina Beth Solomon, Matt Spetalnick, Dave Graham, Humeyra Pamuk; Additional reporting by Jeff Mason, Steve Holland and Dave Sherwood; writing by Matt Spetalnick and Dave Graham; Editing by Grant McCool and Richard Pullin
Our Standards: The Thomson Reuters Trust Principles.
Many Latin American countries now have higher vaccination rates than Europe and North America
That’s due to the accelerated delivery of European, American, Chinese and homegrown vaccines that a number of Latin American nations have received in the second half of this year, according to Pan American Health Organization (PAHO) data.
One reason for those successful vaccination campaigns can be chalked up to history: Many countries in Latin America have long-standing and trusted national inoculation drives against other diseases, such as polio.
Cuba has, perhaps, fared best in this regard, with its bet on its homegrown vaccines — approved for emergency use by its drug regulators this summer — paying off.
Scientists say the Cuban-made vaccines are safe and effective in preventing serious illness and death. The government applied for World Health Organization approval for its vaccines in September.
Brazil has administered more than 315 million doses, with 65.7% of the population fully vaccinated, according to PAHO data up to December 23.
In Ecuador, 69.1% of its eligible population is already fully vaccinated. There, Covid-19 vaccinations will be made mandatory for people who are eligible for the vaccine from ages five and older, the Ecuadorian health ministry said on Thursday, becoming the first country in Latin America to impose such measure for the entire eligible population. The vaccination will not be mandatory for those with pre-existing medical conditions, the health ministry statement said.
And in Peru, which has suffered the highest rate of Covid-19 deaths anywhere in the world, 63.9% of the eligible population is now fully vaccinated.
Regionally, over 868 million doses have been administered as of December 22 in Latin America and the Caribbean, PAHO reported, with around 57% of Latin America and the Caribbean’s population fully vaccinated. That compares to 67.8% in Europe and 61.3% in the United States.
Uneven rates
Still, PAHO warns that vaccination remains uneven across the Latin America and Caribbean region, “with a handful of countries unlikely to reach the 40% vaccination target by the end of the year and many just above the 50% threshold of full COVID-19 immunization.”
Countries that are continuing to struggle with their rollouts include Jamaica and French Guyana, where 18.7% and 25.4% of people are fully vaccinated. Among the larger countries in the region, Mexico has only just passed the 50% threshold.
And as the Omicron variant spreads, like in much of the world, Latin America is beginning to see a spike in reported cases. In the week to December 23, the Americas (which includes the United States and Canada) reported over 1.1 million new Covid-19 infections — a 6% increase in cases from the previous week.
However, much of that rise was driven by cases in the US, with PAHO reporting an overall case drop in South America of 10.7% in cases and a 6.3% decrease in deaths in that week.
Bolivia was the outlier, reporting a sharp increase in cases, as did some parts of the Caribbean, where a PAHO analysis showed cases increased by 16%.
As well as imported vaccines, Latin America is now producing more of its own. This month, PAHO Director General Carissa Etienne welcomed WHO approval of an AstraZeneca vaccine jointly produced by Argentina and Mexico — the first in Latin America.
“This is an important milestone for Latin America and highlights the importance of technology transfer to increase the availability of quality COVID-19 vaccines in the region,” Etienne said.
Efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate in ten countries in Europe and Latin America (HERALD): a randomised, observer-blinded, placebo-controlled, phase 2b/3 trial
Summary
Background
Additional safe and efficacious vaccines are needed to control the COVID-19 pandemic. We aimed to analyse the efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate.
Methods
Findings
Between Dec 11, 2020, and April 12, 2021, 39 680 participants were enrolled and randomly assigned to receive either CVnCoV (n=19 846) or placebo (n=19 834), of whom 19 783 received at least one dose of CVnCoV and 19 746 received at least one dose of placebo. After a mean observation period of 48·2 days (SE 0·2), 83 cases of COVID-19 occurred in the CVnCoV group (n=12 851) in 1735·29 person-years and 145 cases occurred in the placebo group (n=12 211) in 1569·87 person-years, resulting in an overall vaccine efficacy against symptomatic COVID-19 of 48·2% (95·826% CI 31·0–61·4; p=0·016). Vaccine efficacy against moderate-to-severe COVID-19 was 70·7% (95% CI 42·5–86·1; CVnCoV 12 cases in 1735·29 person-years, placebo 37 cases in 1569·87 person-years). In participants aged 18–60 years, vaccine efficacy against symptomatic disease was 52·5% (95% CI 36·2–64·8; CVnCoV 71 cases in 1591·47 person-years, placebo, 136 cases in 1449·23 person-years). Too few cases occurred in participants aged 61 years or older (CVnCoV 12, placebo nine) to allow meaningful assessment of vaccine efficacy. Solicited adverse events, which were mostly systemic, were more common in CVnCoV recipients (1933 [96·5%] of 2003) than in placebo recipients (1344 [67·9%] of 1978), with 542 (27·1%) CVnCoV recipients and 61 (3·1%) placebo recipients reporting grade 3 solicited adverse events. The most frequently reported local reaction after any dose in the CVnCoV group was injection-site pain (1678 [83·6%] of 2007), with 22 grade 3 reactions, and the most frequently reported systematic reactions were fatigue (1603 [80·0%] of 2003) and headache (1541 [76·9%] of 2003). 82 (0·4%) of 19 783 CVnCoV recipients reported 100 serious adverse events and 66 (0·3%) of 19 746 placebo recipients reported 76 serious adverse events. Eight serious adverse events in five CVnCoV recipients and two serious adverse events in two placebo recipients were considered vaccination-related. None of the fatal serious adverse events reported (eight in the CVnCoV group and six in the placebo group) were considered to be related to study vaccination. Adverse events of special interest were reported for 38 (0·2%) participants in the CVnCoV group and 31 (0·2%) participants in the placebo group. These events were considered to be related to the trial vaccine for 14 (<0·1%) participants in the CVnCoV group and for five (<0·1%) participants in the placebo group.
Interpretation
CVnCoV was efficacious in the prevention of COVID-19 of any severity and had an acceptable safety profile. Taking into account the changing environment, including the emergence of SARS-CoV-2 variants, and timelines for further development, the decision has been made to cease activities on the CVnCoV candidate and to focus efforts on the development of next-generation vaccine candidates.
Funding
German Federal Ministry of Education and Research and CureVac.
Introduction
WHO coronavirus (COVID-19) dashboard.
Through unprecedented effort from governments, national and international research funders, regulatory bodies, and research organisations, vaccine development has been, and continues to be, expedited. The first conditionally approved vaccine in Europe was administered in December, 2020, within 9 months of WHO characterising COVID-19 as a pandemic on March 11, 2020.
WHO Director-General’s opening remarks at the media briefing on COVID-19—11 March 2020.
The COVID-19 vaccine race—weekly update.
These vaccines have been developed by use of different platforms, all with specific advantages and disadvantages.
mRNA is a promising platform that allows the rapid development of immunogens and vaccine production.
- Pardi N
- Hogan MJ
- Porter FW
- Weissman D
,
- Jackson NAC
- Kester KE
- Casimiro D
- Gurunathan S
- DeRosa F
The BNT162b2 (Pfizer-BioNtech) and mRNA-1273 (Moderna) SARS-CoV-2 vaccines were the first mRNA preventive vaccines to be approved for emergency use in humans in Europe and the USA on the basis of data from phase 3 efficacy trials.
- Polack FP
- Thomas SJ
- Kitchin N
- et al.
,
- Baden LR
- El Sahly HM
- Essink B
- et al.
- Rauch S
- Roth N
- Schwendt K
- Fotin-Mleczek M
- Mueller SO
- Petsch B
,
- Rauch S
- Gooch K
- Hall Y
- et al.
In a phase 1 dose-escalation study, two doses of CVnCoV administered 28 days apart were safe and immunogenic, with dose-dependent increases in anti-spike protein IgG antibodies and SARS-CoV-2-neutralising antibodies.
- Kremsner PG
- Mann P
- Kroidl A
- et al.
Median antibody titres against spike protein and its receptor binding domain after two 12 μg doses of CVnCoV were similar to those observed in convalescent serum samples from patients with COVID-19, with seroconversion observed 2 weeks after the second dose in all participants receiving this dosage. On the basis of these findings, the 12 μg dose was selected for further phase 2/3 testing. We aimed to analyse the efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate in a phase 2b/3 trial.
Evidence before this study
We searched PubMed for clinical trials published between Jan 1, 2019, and Sept 19, 2021, without language restrictions, using the terms ‘SARS-CoV-2’ OR ‘COVID-19’ AND ‘Vaccine’ AND ‘Efficacy’. At the time of the search, we identified 12 peer-reviewed publications of phase 2/3 and phase 3 clinical trials reporting the efficacy of COVID-19 vaccines in different populations. We did not consider press releases or preprints as sources of information. Eight primary publications reported vaccine efficacies ranging from 62% to 95%. The mRNA-1273 (Moderna) and BNT162b2 (Pfizer-BioNtech) mRNA vaccines have shown 94% and 95% efficacy, respectively, in preventing COVID-19, with cases accrued at a time when no circulating variants had been identified. Variant-dependent differences in vaccine efficacy have been reported, with reductions in efficacy of up to 60 percentage points against newly emerged SARS-CoV-2 variants of concern.
Added value of this study
We report the primary efficacy analysis of the CVnCoV mRNA vaccine candidate from the phase 2b/3 HERALD trial that comprised 39 680 participants from ten countries in Europe and Latin America. CVnCoV had an acceptable safety profile. Solicited adverse events were common, and more frequently reported in the CVnCoV group than in the placebo group, but the median duration of grade 3 solicited adverse events was 1 day. CVnCoV was 48·2% efficacious in the prevention of COVID-19 of any severity in a variant-dominated setting. Indeed, only seven (3%) of all 204 sequenced COVID-19 cases were of B.1 lineage, with the others caused by 14 different variants. In Europe, 45 (92%) of 49 cases were caused by the alpha variant of concern (B.1.1.7), compared with Latin America where 20 (13%) of 155 cases were caused by the alpha variant and 35 (23%) cases were caused by the gamma variant of concern (P.1).
Implications of all the available evidence
In view of the changing environment, including the emergence of SARS-CoV-2 variants, and taking into account timelines for further development, the decision has been made to cease activities on the CVnCoV candidate and to focus efforts on the promising and rapidly progressing development of next-generation vaccine candidates. In addition, it might be necessary to consider alternative designs for future global efficacy trials given the number of rapidly emerging SARS-CoV-2 variants and the high uptake of COVID-19 vaccines under emergency use authorisation.
Methods
Study design and participants
The initial phase 2b part of the trial was designed to characterise the safety, reactogenicity, and immunogenicity of the CVnCoV vaccine candidate, and the phase 3 part of the trial was designed to evaluate its efficacy and safety. The two parts of the trial were designed to allow participants with COVID-19 accrued in the phase 2b part of the trial to be pooled with those in the phase 3 part of the trial for the primary analysis of vaccine efficacy. An independent data and safety monitoring board (DSMB) conducted interim safety reviews of the phase 2b part of the trial before enrolment for the phase 3 part of the trial was initiated and will continue to monitor safety until study end. An enrolment target was that 20–25% of the population would be aged 61 years or older. We planned to enrol the first 4000 participants in the phase 2b part of the trial and to include the first 600 participants in each age group in the assessment of immunogenicity endpoints. The DSMB reviewed the safety data when approximately 1800 participants (900 in both treatment groups) had been enrolled in the phase 2b part of the trial and had at least 1 week of safety follow-up after the first dose. Enrolment of participants into the phase 3 part of the trial would begin without interruption from the phase 2b part of the trial if the safety profile was considered acceptable. The DSMB also reviewed all safety data after all participants in each group in the phase 2b trial had received their second trial vaccination and had at least 1 week of safety follow-up.
The trial protocol and its amendments received ethics approval from the appropriate independent ethics committees or institutional review boards at each study centre. The trial is being conducted in accordance with the provisions of the Declaration of Helsinki and the International Conference on Harmonisation Good Clinical Practice guidelines. All participants provided written informed consent before initiation of any trial procedures.
Randomisation and masking
Trial participants were randomly assigned (1:1) to receive either CVnCoV or placebo. Randomisation, stratified by country and age group (18–60 years and ≥61 years), was done centrally by use of an interactive web response system. The randomisation scheme was generated and managed by an independent statistics group at the contract research organisation, PRA. Due to the difference in appearance and presentation between the CVnCoV vaccine candidate and placebo, site personnel involved in preparing the vaccine masked the content of the syringe with a label and were not involved in further conduct of the trial. Investigators, site personnel, and others directly involved in the conduct of the trial were masked to participant allocation for the duration of the trial. The statisticians analysing the data were masked to group assignment until the final analyses. Unmasking of participants was allowed in emergency situations for reasons of participant safety or for participants who became eligible to receive an authorised SARS-CoV-2 vaccine and requested unmasking.
Procedures
Participants in both the phase 2b and the phase 3 parts of the trial received either two 0·6 mL doses of CVnCoV containing 12 μg of mRNA, formulated with the RNActive mRNA vaccine platform, or two 0·6 mL doses of 0·9% NaCl (placebo) on days 1 and 29. Each 0·6 mL dose was administered by intramuscular injection in the deltoid area. Blood samples (6 mL) were taken from all participants on day 1 and day 43 (14 days after the second dose) and will be taken on day 211 and day 393 (study end) to measure SARS-CoV-2 nucleocapsid protein serostatus. The samples were sent to one of two central laboratories in the USA or the Netherlands and tested with the Elecsys assay on the COBAS system (Roche Diagnostics; Mannheim, Germany). The results on day 1 and day 43 identified whether participants were naive to SARS-CoV-2 infection at trial entry and 15 days after the second vaccination, and were therefore eligible for inclusion in the efficacy analysis subset.
US Food and Drug Administration. Development and licensure of vaccines to prevent COVID-19. Guidance for industry.
and participants were contacted twice per week by site staff via a mobile application to respond yes or no to having potential COVID-19 symptoms. Site personnel then contacted participants who replied yes to ascertain whether their symptoms were indicative of COVID-19 by following a scripted interview. Upon suspicion of COVID-19, participants underwent a rapid antigen test (Abbott Panbio COVID-19 Ag Rapid Test; Jena, Germany) to allow them to comply with local quarantine rules if the results were positive. In addition, samples were sent to central laboratories for SARS-CoV-2-specific RT-PCR testing (In-house test, with probes and primers from Eurofins [Louisville KY, USA]; Latin America testing done in Lancaster [PA, USA]; European testing done in Breda [Netherlands]) for virological confirmation of COVID-19. In case of discrepancies between tests, the RT-PCR test result was considered definitive. All primary efficacy cases were confirmed by an independent adjudication committee. Sequencing of the complete viral single stranded RNA genome was carried out using Illumina Next Generation Sequencing (Viracor-Eurofins, Lee’s Summit, MO, USA).
US Food and Drug Administration. COVID-19: developing drugs and biological products for treatment or prevention. Guidance for industry.
Outcomes
The primary efficacy outcome was the occurrence of a first episode of virologically confirmed symptomatic COVID-19 of any severity and caused by any strain from 15 days after the second dose up to 1 year. The primary outcome was assessed by a blinded, central adjudication committee. Key secondary efficacy outcomes included the occurrence of a first episode of virologically confirmed moderate-to-severe COVID-19, and the occurrence of a first episode of virologically confirmed severe COVID-19, overall and by age group (18–60 years vs ≥61 years). An exploratory efficacy endpoint, which was added in the protocol amendment on March 29, 2021, was the occurrence of a first episode of virologically confirmed COVID-19 caused by an individual variant of concern or interest.
Statistical analysis
HERALD is an event-driven trial, and sample size and power considerations were based on the primary objective of showing the efficacy of CVnCoV in preventing virologically confirmed cases of COVID-19 of any severity meeting the primary case definition. Assuming a vaccine efficacy of 60%, with an overall two-sided α of 5%, we estimated that 160 participants with COVID-19 of any severity, with a third of cases being moderate to severe, were needed for the final analysis to have a power of 90% to show a vaccine efficacy of more than 30% based on the lower bound of the CI for efficacy. Assuming a COVID-19 incidence of 0·15% per month in participants in the placebo group, an overall non-evaluable proportion of 20% (corresponding to participants excluded from the efficacy analysis set and those who dropped out), and a vaccine efficacy of 60%, we estimated that 36 500 participants (18 250 per group) enrolled over approximately 3 months would accrue 160 COVID-19 cases of any severity at approximately 9 months after the first vaccination.
During case accrual, before the second interim analysis was done, we observed that the actual proportion of participants with moderate-to-severe COVID-19 was approximately 20%, which was lower than the expected 30%. The protocol was amended to allow accrual of more cases to obtain the planned sample size (about 53 participants with moderate-to-severe COVID-19) needed for the key secondary endpoint of measuring vaccine efficacy against moderate-to-severe COVID-19.
Vaccine efficacy against symptomatic disease was analysed in the primary efficacy analysis set, which comprised all participants in the phase 2b and phase 3 parts of the trial who received both doses of either CVnCoV or placebo according to their treatment allocation, had not developed virologically confirmed COVID-19 before day 43 (15 days after the second dose), and were SARS-CoV-2-naive at baseline and day 43. Vaccine efficacy was defined as 1 minus the ratio of the attack rate in participants receiving CVnCoV to participants receiving placebo, multiplied by 100. In each group, the attack rate was defined as the number of participants presenting with virologically confirmed COVID-19 divided by the total follow-up time. For the primary analysis, the hypothesis was tested with the exact test for binomial proportions. The trial was considered successful if the lower limit of the exact two-sided Clopper-Pearson 95% CI (subject to adjustment for multiple testing according to the cumulative O’Brien-Fleming type error spending function, giving an actual CI of 95·826%) of the primary efficacy endpoint (COVID-19 cases of any severity) was more than 30%. Success for key secondary endpoints was defined as the lower limit of the exact two-sided 95% CI being more than 20% for moderate-to-severe disease, and more than 10% for severe disease. Kaplan-Meier curves and associated log-rank tests were done in a key prespecified sensitivity analysis to evaluate time to first occurrence of virologically confirmed COVID-19. Post-hoc, we evaluated vaccine efficacy by region.
Role of the funding source
CureVac was responsible for trial design and conduct, data analysis, data interpretation, and writing of the report. The German Federal Ministry of Education and Research had no role in study design, data collection, data analysis, data interpretation, or writing of the report.
Results
Table 1Baseline and day 43 characteristics in the phase 2b–3 safety analysis set
Data are n (%), median (IQR), or n/N (%). The phase 2b–3 safety analysis set comprises all participants who received at least one dose of CVnCoV or placebo, who are analysed in the group of the treatment dose received. BMI=body-mass index.
Table 2Efficacy of CVnCoV against virologically confirmed COVID-19 occurring 15 days or more after the second dose in the primary efficacy analysis set
Tracking SARS-CoV-2 variants.
In Europe, 45 (92%) of 49 cases were caused by the alpha variant (the remaining four cases were caused by the gamma variant [P.1; two], by the delta variant [B.1.617.2; one], and by an unidentified variant at the time [one]). In Latin America, 20 (13%) of 155 cases were caused by the alpha variant, 34 (22%) were caused by the gamma variant, 43 (28%) were caused by the lambda variant of interest (C.37), and 29 (19%) were caused by the Mu variant of interest (B.1.621). The remaining cases were caused by alpha (20 [13%]), B.1.526 (iota; one [1%]), wild-type (seven [5%]), P.2 (zeta; one [1%]), and other (20 [13%]). Vaccine efficacies against the alpha, gamma, and lambda variants in people aged 18–60 years were similar to the overall efficacy (table 2).
Table 3Adverse events
Data are n/N (%) or n/N (%); number of events. Serious adverse events are reported from immediately after the second dose to the date of data cutoff (June 18, 2021).
Discussion
Considerations for evaluation of COVID19 vaccines.
Vaccine efficacy against COVID-19 of any severity was 48·2% (95·826% CI 31·0–61·4) in the overall primary efficacy analysis set of SARS-CoV-2-naive participants, and 52·5% (95% CI 36·2–64·8) in those aged 18–60 years. Vaccine efficacy against moderate-to-severe COVID-19 was 70·7% (42·5–86·1) overall and 77·2% (51·8–90·4) in participants aged 18–60 years. There were too few participants aged 61 years or older who developed COVID-19 to allow a meaningful estimate of efficacy in this age group.
- Polack FP
- Thomas SJ
- Kitchin N
- et al.
,
- Baden LR
- El Sahly HM
- Essink B
- et al.
No increase in solicited reactions was seen between the first and second CVnCoV doses. Serious adverse events and adverse events of special interest were uncommon and similar in frequency between the CVnCoV and placebo groups, although the short follow-up duration needs to be considered when interpreting these findings. The safety of the CVnCoV vaccine candidate will continue to be monitored for the duration of the trial, and findings will be presented in a future publication. Taken together with the safety data from phase 1 trials with CVnCoV and with the CV7202 rabies mRNA vaccine,
- Kremsner PG
- Mann P
- Kroidl A
- et al.
,
- Aldrich C
- Leroux-Roels I
- Huang KB
- et al.
the findings observed in this trial provide further support for the safety of the RNActive mRNA vaccine platform.
- Rauch S
- Lutz J
- Kowalczyk A
- Schlake T
- Heidenreich R
Tracking SARS-CoV-2 variants.
Although we were only able to evaluate vaccine efficacy against these variants in participants aged 18–60 years, the results indicate that the vaccine had similar efficacies against alpha, gamma, and lambda variants. Many newly emerged strains have shown increased transmissibility,
- Hossain MK
- Hassanzadeganroudsari M
- Apostolopoulos V
and differences in neutralising antibody activity against these strains might alter vaccine efficacy.
- Garcia-Beltran WF
- Lam EC
- St Denis K
- et al.
These concerns are supported by results from other phase 3 efficacy trials, with SARS-CoV-2 variant-dependent differences in efficacy reported for the ChAdOx1 nCoV-19 (Oxford-AstraZeneca),
- Voysey M
- Clemens SAC
- Madhi SA
- et al.
,
- Emary KRW
- Golubchik T
- Aley PK
- et al.
,
- Madhi SA
- Baillie V
- Cutland CL
- et al.
NVX-CoV2373 (Novavax),
- Heath PT
- Galiza EP
- Baxter DN
- et al.
,
- Shinde V
- Bhikha S
- Hoosain Z
- et al.
and Ad26.COV2.S (Janssen) SARS-CoV-2 vaccines.
- Sadoff J
- Gray G
- Vandebosch A
- et al.
The point estimates for real-world mRNA vaccine effectiveness, in settings with increasing diversity of variants, are lower than the point estimates for efficacy as reported in clinical trials.
- Kustin T
- Harel N
- Finkel U
- et al.
,
- Puranik A
- Lenehan PJ
- Silvert E
- et al.
,
- Nasreen S
- He S
- Chung H
- et al.
In this context, the comparison of vaccine efficacy against different SARS-CoV-2 variants and between Europe and Latin America, although not prespecified in the protocol, is important from a public health perspective. Broad geographical representation should therefore be considered when designing future studies evaluating the efficacy of SARS-CoV-2 vaccines and vaccine efficacy against emerging variants.
- Polack FP
- Thomas SJ
- Kitchin N
- et al.
,
- Baden LR
- El Sahly HM
- Essink B
- et al.
,
- Voysey M
- Clemens SAC
- Madhi SA
- et al.
,
- Heath PT
- Galiza EP
- Baxter DN
- et al.
,
- Sadoff J
- Gray G
- Vandebosch A
- et al.
The low recruitment, combined with the large number of older participants who were unmasked and therefore contributed less follow-up time to the efficacy analyses, limited the interpretability of our findings in this age group and affected the overall study results.
- Polack FP
- Thomas SJ
- Kitchin N
- et al.
,
- Baden LR
- El Sahly HM
- Essink B
- et al.
,
- Heath PT
- Galiza EP
- Baxter DN
- et al.
,
- Sadoff J
- Gray G
- Vandebosch A
- et al.
The clinical implications of CVnCoV’s 70·7% efficacy against moderate-to-severe COVID-19, nearly all cases of which were caused by variants of concern or variants of interest, suggest a high potential for a positive impact on public health. Access to vaccines protecting against moderate-to-severe disease, and thus preventing disruption to the normal functioning of hospitals and intensive care units, is essential to prevent non-COVID-19-associated morbidity and mortality.
- Berg GM
- Wyse RJ
- Morse JL
- et al.
,
- Woolf SH
- Chapman DA
- Sabo RT
- Weinberger DM
- Hill L
- Taylor DDH
,
- Dopfer C
- Wetzke M
- Zychlinsky Scharff A
- et al.
- Kremsner PG
- Mann P
- Kroidl A
- et al.
However, in view of the changing environment, including the emergence of SARS-CoV-2 variants, and taking into account timelines for further development, the decision had been made to cease activities on the CVnCoV candidate, and to focus efforts on the promising and rapidly progressing development of the next generation vaccine candidates. One of these, the CV2CoV candidate, has already been shown to induce high humoral and cellular immune responses in non-human primate studies.
- Gebre MS
- Rauch S
- Roth N
- et al.
In conclusion, the two-dose regimen of CVnCoV had an acceptable safety profile and was efficacious in the prevention of symptomatic COVID-19 in adults. In addition, we observed vaccine efficacy against newly emerged variants, including variants of concern.
Contributors
PGK, AK, IL-R, PM, OS-K, TV, and LO conceived the HERALD trial; PGK is the coordinating investigator and LO is study lead. HJ is the qualified physician and co-chair of the DSMB. PGK, RC, EJLDB, MAGG, AK, IL-R, PM, MFM-R, OS-K, TV, and LO contributed to the trial design and protocol. PGK, HJ, PM, and TV participated in the data curation and had full access to and verified all study data. PGK, AK, PM, OS-K, TV, and LO did the statistical analyses. PGK, RAAG, EA-A, GJAM, MB, RC, RC GC, EJLDB, LE, JJG, CAGL, LG, MAGG, NG, MPG, ADH, CFL, CL, IL-R, MFM-R, TJO, CAP, MJRF, LMRM, VVRH, XS-L, MS, ASG, IV, and MV are study site principal investigators. PGK, PM, OS-K, and LO were in the core writing group responsible for preparation of the manuscript and received support from a medical writer. Manuscript drafts were reviewed by all authors, and the content of the submitted version was approved by all authors before submission. All authors had final responsibility for the decision to submit for publication. Because the study is ongoing, authors could not be given access to the whole dataset analysed in this Article, but they will be given full access when the study is terminated.
Data sharing
Anonymised participant data will be made available when the trial is complete, on requests directed to the corresponding author. Proposals will be reviewed and approved by the sponsor, investigator, and collaborators on the basis of scientific merit. After approval of a proposal, data can only be shared through a secure online platform after a data access agreement is signed. All data will be made available for a minimum of 5 years from the end of the trial.
Declaration of interests
MB declares institutional funding from CureVac during the conduct of this study, institutional funding from Janssen Vaccines, Molecular Partners, and Merck outside the submitted work, and consulting fees from Janssen Vaccines outside the submitted work. EJLDB, MFM-R, TJO, and XS-L declare institutional funding from CureVac during the conduct of this study. LE and LG declare institutional funding from CureVac during the conduct of this study and outside the submitted work. CFL declares institutional funding from CureVac during the conduct of this study and outside the submitted work and is a member of the WHO Covid-19 Vaccine Effectiveness Working Group and the WHO Product Development for Vaccines Advisory Committee. CL declares institutional funding from CureVac during the conduct of this study and is a member of the German Society of Infection board. IL-R declares institutional funding from CureVac during the conduct of this study and institutional funding from Johnson & Johnson and OSE Immunotherapeutics outside the submitted work. PGK declares institutional funding from CureVac during the conduct of this study and is a member of the scientific advisory board for the HERALD clinical trial. VVRH declares institutional funding from CureVac during the conduct of this study and speakers fees from Gilead outside the submitted work. HJ declares consultant fees from CureVac, is the qualified physician for the HERALD clinical trial, and is co-chair of the DSMB for the HERALD clinical trial. AK and PM are employed by CureVac and hold stock options. OS-K declares consultant fees from CureVac during the conduct of this study and is a member of the DSMB for a CVnCoV phase 1 trial. TV declares consultant fees from CureVac during the conduct of this study, and consultant fees from CureVac, AstraZeneca, Pfizer, Johnson & Johnson, and Moderna outside the submitted work. LO is employed by CureVac and holds stock options and is the holder of a pending patent. All other authors declare no competing interests.
Acknowledgments
This study was funded by the German Federal Ministry of Education and Research ( grant 01KI20703 ) and CureVac. Draft versions of this manuscript were reviewed by Giulia Povellato and Robert Tensen (Medical Affairs Department, CureVac, Frankfurt, Germany). Medical writing services were provided by Jarno Jansen and Margaret Haugh, who also provided editorial support, both funded by CureVac. We thank all study participants for their contribution to HERALD. We also thank all staff at the clinical study centres, the contract research organisations, the laboratories, and in CureVac, who are too numerous to be named but are nonetheless recognised for their tireless work, which is still ongoing. Special thanks go to the members of the DMSB, chaired by Fred Zepp.
Supplementary Material
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Article Info
Publication History
Published: November 23, 2021
Identification
DOI: https://doi.org/10.1016/S1473-3099(21)00677-0
Copyright
© 2021 Elsevier Ltd. All rights reserved.
ScienceDirect
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Linked Articles
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Apart from COVID-19-appropriate behaviour, effective vaccine coverage is the single most important intervention needed to control the ongoing SARS-CoV-2 pandemic. Although several vaccines are being used under emergency use authorisation, worldwide vaccination coverage will only be achieved when vaccine availability exceeds vaccine demand. Globally, several prominent institutions, universities, and leading pharmaceutical companies have successfully developed COVID-19 vaccine candidates that have progressed to clinical trials.
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Live Updates: First Latin Grammys Awarded Ahead of the Show
The Latin Grammys exult in spectacle. Last year, Karol G danced on a pink platform between two unicorns, J Balvin sang under a giant pair of praying hands and Bad Bunny belted “Bichiyal” from a moving car.
This year, Bad Bunny will return as part of a lineup stocked with big names, including Myke Towers and Christina Aguilera. In-person acceptance speeches and performances will take place in Las Vegas at the MGM Grand Garden Arena, at a ceremony hosted by the actresses Ana Brenda Contreras and Roselyn Sánchez and the singer Carlos Rivera.
The 22nd annual Latin Grammys will be shown live on Thursday at 8 p.m. Eastern on Univision and available on the Univision app, although subscription fees may apply. The event will also air on TNT at 7 p.m. in Mexico, 8 p.m. in Panama and Colombia, 9 p.m. in Venezuela and 10 p.m. in Argentina and Chile.
Gloria Estefan will kick off the show with a three-song medley and guests including Anitta, Carlinhos Brown, Laércio da Costa, Pedro Capó, Farina Giulia Be and Diego Torres.
Other performers include Rubén Blades (who will be honored as the person of the year) with Roberto Delgado & Orquesta, as well as Maná, Pablo Alborán, Alejandro Fernández, Nella, Ozuna, Paula Arenas, Danna Paola, Banda El Recodo de Cruz Lizárraga, Calibre 50, Los Dos Carnales, Camilo, Julio Reyes Copello, DJ Nelson, Sergio George, Grupo Firme and Jay Wheeler.
Juanes will be joined by Rubén Albarrán and Meme del Real of Café Tacvba for Juan Gabriel’s “No Tengo Dinero,” and C. Tangana will take the stage with Antonio Carmona, Diego del Morao, Jorge Drexler, Israel Fernández, La Húngara, Natalia Lafourcade and Omar Apollo. Descemer Bueno, Gente de Zona and Yotuel will debut an acoustic performance of “Patria y Vida,” nominated for song of the year. Mon Laferte and Gloria Trevi will team with La Arrolladora Banda El Limón de René Camacho for “La Mujer,” nominated for best pop song.
And Christina Aguilera, who last took the Latin Grammys stage in 2000, has announced an extended performance that includes her latest single, “Pa Mis Muchachas,” with Nicki Nicole, Nathy Peluso and Becky G.
Keep an eye out for the ever-contested record of the year category, this year an 11-track race among “Si Hubieras Querido” by Pablo Alborán, “Todo De Ti” by Rauw Alejandro, “Un Amor Eterno (Versión Balada)” by Marc Anthony, “A Tu Lado” by Paula Arenas, “Bohemio” by Andrés Calamaro and Julio Iglesias, “Vida De Rico” by Camilo, “Suéltame, Bogotá” by Diamante Eléctrico, “Amén” by Ricardo Montaner, Mau y Ricky, Camilo and Evaluna Montaner, “Dios Así Lo Quiso” by Ricardo Montaner and Juan Luis Guerra, “Te Olvidaste” by C. Tangana and Omar Apollo and “Talvez” by Caetano Veloso and Tom Veloso.
The official premiere ceremony — the show before the main event where 45 of the 53 categories will be awarded — begins at 4 p.m., hosted by the singer-songwriter Kany García and the actress Carolina Dieckmann. It will be held at the Michelob Ultra Arena at Mandalay Bay, and webcast globally via the Latin Grammys’ Facebook Live and YouTube channel.
The premiere ceremony will also feature performances by a host of nominees, including Gera Demara, Nora González, Zoe Gotusso, Love of Lesbian, Luedji Luna, Os Barões da Pisadinha, Nando Reis, Gonzalo Rubalcaba and Jon Secada. Lupita Infante, who was previously nominated, will appear as a special guest.
For the second time, all Portuguese language categories will be awarded separately in a premiere ceremony for Brazilian audiences that follows the 4 p.m. event.