Check out the companies making headlines before the bell:
Tapestry (TPR) – The company behind the Coach and Kate Spade brands beat top and bottom line estimates for its latest quarter, but cut its full-year forecast for the impact of the strong U.S. dollar and China’s Covid-19 restrictions. Tapestry slid 2% in premarket trading.
Nio (NIO) – The China-based electric car maker posted a wider-than-expected quarterly loss, but said it expected deliveries to nearly double in the current quarter from a year ago. Nio shares jumped 5.5% in premarket trading.
WeWork (WE) – The office-sharing company’s stock fell 1.7% in the premarket after it reported a wider-than-expected quarterly loss. WeWork also plans to exit about 40 underperforming locations this month.
Six Flags (SIX) – The theme park operator’s stock initially dipped in premarket trading after it missed top and bottom line estimates for its latest quarter. However, it rebounded to a 2.9% gain after announcing an agreement with investment firm H Partners that raised the cap on H Partners’ stake in the company to 19.9% from 14.9%.
Rivian (RIVN) – Rivian rallied 8.2% in off-hours trading after the electric vehicle maker reported a narrower-than-expected quarterly loss and kept its production schedule intact, even in the face of supply chain issues.
Dutch Bros (BROS) – Dutch Bros stock jumped 3.8% in the premarket after the operator of hand-crafted beverage shops reported better-than-expected profit and revenue for its latest quarter. The company also raised its full-year revenue outlook.
AstraZeneca (AZN) – AstraZeneca gained 4.8% in premarket trading after the drug maker reported upbeat quarterly results and raised its full-year profit forecast. AstraZeneca’s results got a boost from strong sales of its cancer drugs.
Bumble (BMBL) – Bumble slumped 14% in premarket action after issuing a weak current-quarter revenue forecast. The dating service operator said its users are renewing subscriptions at a slower rate as consumers cut back on discretionary spending in the face of inflation.
Fair Isaac (FICO) – Fair Isaac staged a 10.4% rally in the premarket after its quarterly earnings beat analyst estimates and revenue grew in both its credit score and software units. The company, known for FICO credit scores, also gave an upbeat full-year forecast.
ZipRecruiter (ZIP) – ZipRecruiter surged 12.6% in premarket trading after the online jobs site operator posted better-than-expected quarterly results and raised its full-year forecast. ZipRecruiter also announced a $200 million increase in its share repurchase program.
Emerging omicron subvariants are resistant to key antibody treatments for HIV patients, kidney transplant recipients and other immunocompromised people, making them particularly vulnerable to Covid this winter, the White House warned this week.
“With some of the new subvariants that are emerging, some of the main tools we’ve had to protect the immunocompromised like Evusheld may not work moving forward. And that’s a huge challenge,” Dr. Ashish Jha, head of the White House Covid task force, told reporters on Tuesday.
President Joe Biden on Tuesday cautioned the estimated 7 million adults in the U.S. who have compromised immune systems that they are particularly at risk, but he could offer little in the way of reassurance other than telling them to consult their physician about what precautions to take.
“New variants may make some existing protections ineffective for the immunocompromised,” the president said before getting his booster Tuesday. “Sadly, this means you may be at a special risk this winter. I urge you to consult your doctors on the right steps to protect yourself, take extra precautions.”
The message clashes with repeated White House assurances that the U.S. has all the vaccines and treatments it needs to fight Covid this winter as public health officials are expecting another surge.
While this may be true for the general population, it is not the case for people with weak immune systems. They include those with cancer, those who have had organ transplants, people living with HIV and individuals who are taking medicine for autoimmune diseases.
Evusheld is an antibody cocktail authorized by the Food and Drug Administration to prevent Covid in people ages 12 and older who have moderately or severely compromised immune systems. The drug is administered as two injections, prior to infection, every six months.
Evusheld, made by AstraZeneca, has helped fill a gap in protection for those with weak immune systems who cannot mount a strong response to the vaccines. The drug, plus several rounds of vaccination, has led to significant declines in hospitalization among this cohort over the past several months, according Camille Kotton, an infectious disease expert who specializes in treating people with weak immune systems.
“We’ve been in a sweet spot for maybe several months now as far as immunocompromised patients having good protection and then good treatment options,” said Kotton, a physician at Massachusetts General Hospital and a member of the Centers for Disease Control and Prevention’s independent vaccine advisory committee.
But more immune evasive omicron subvariants such as BA.4.6, BA.2.75.2, BF.7, BQ.1 and BQ.1.1 are resistant to Evusheld, according to the National Institutes of Health. Scientists at Columbia University, for example, found Evusheld had completely lost its effectiveness against BA.4.6.
And BQ.1 and BQ.1.1 are likely resistant to bebtelovimab, the monoclonal antibody developed by Eli Lily to prevent people with compromised immune systems who catch Covid from developing severe disease, according to NIH.
That leaves people with compromised immune systems increasingly vulnerable as these subvariants increase in circulation in the U.S. As omicron BA.5 declines, this swarm of newer subvariants collectively make up about 38% of infections in the U.S., according to CDC data.
Although Pfizer’s antiviral Paxlovid remains effective against the omicron subvariants, people who have had organ transplants often can’t take the pill because of the way it interacts with other drugs they need, Kotton said.
“I’m concerned that the near future will be a challenging time for immunocompromised patients,” said Kotton. “The monoclonal antibodies in Evusheld are going to provide less protection and bebtelovimab is going to provide ineffective treatment for several of the emerging variants.”
And help is not on the way at the moment. Kotton said she’s not aware of any monoclonal antibodies that are ready to replace the ones the subvariants are chipping away at. Jha acknowledged at the White House on Tuesday that the U.S. has dwindling treatment and prevention options for people with weak immune systems as Covid evolves. He blamed Congress for failing to pass $22.5 billion in funding for the nation’s Covid response due to Republican opposition.
“We had hoped that over time as the pandemic went along, as our fight against this virus went along, we would be expanding our medicine cabinet,” Jha told reporters. “Because of lack of congressional funding that medicine cabinet has actually shrunk and that does put vulnerable people at risk.”
Andrew Pekosz, a virologist at Johns Hopkins University, said finding ways to protect people with compromised immune systems is the most critical issue of the pandemic right now and it needs to be addressed quickly.
“What we need to really work on is getting new antibody treatments out of the lab and into clinics,” Pekosz said. “In the lab, scientists know what next-generation monoclonal antibodies look like.”
Kotton said people with compromised immune systems should stay up to date on their vaccines, which means getting the new booster that targets omicron BA.5. Those who have stayed up to date throughout the pandemic have received six shots by now.
Those starting from scratch would receive a three-dose primary series of Moderna or Pfizer with the older generation shots and then a new booster that targets omicron, according to CDC guidelines.
People with compromised immune systems should continue to exercise caution this winter, because the immune-resistant omicron subvariants could pick up in circulation as people gather for the holidays, Kotton said. But she noted that the group has been more diligent in wearing masks and practicing mitigation measures to avoid the virus than the rest of the population.
The bigger problem is that the general population has largely moved on and is no longer taking basic precautions that could reduce transmissions and protect the vulnerable — such as wearing masks, Kotton said.
“If we all were to mask more in public venues that would enhance the safety for them and allow them to have a higher likelihood of a safer return to many activities,” she said.
Jha was asked by NBC News on Tuesday whether Biden telling people with weak immune systems to consult their physicians about precautions is an indication that the burden of responsibility has shifted to the individuals instead of the broader community.
“As a society — as a caring society, we care about all Americans, particularly the most vulnerable Americans,” Jha said. “So it remains, I think, a collective responsibility for all of us to care about our fellow Americans who are immunocompromised.”
The CDC recommends that people in communities where the Covid risk level is moderate to self test and wear a high-quality mask before meeting indoors with someone who is at high risk of getting sick. Those who are at high risk should wear a high-quality mask when indoors in public.
When the Covid level is high, people in general should consider wearing high-quality masks and the vulnerable should consider avoiding indoor activities in public that aren’t essential, according to CDC. You can check your county’s Covid level at the CDC’s website.
Investors should consider purchasing stock of the first quarter’s biggest losers if the market shows signs of recovering on its own, CNBC’s Jim Cramer said Monday.
“This market’s screaming that we’re headed for a [Federal Reserve]-mandated slowdown, that could possibly become a Fed-mandated recession,” the “Mad Money” host said. “If we get more signs that inflation is cooling on its own, like the pullback in oil, then some of the hardest hit stocks might end up looking pretty enticing.”
The first quarter of 2022 was marked by rampant volatility. Russia’s ongoing invasion of Ukraine in February sent commodities prices including oil skyrocketing, while in March the Fed took its first interest rate hike in three years in an attempt to tamp down rising prices. Global Covid outbreaks last month also caused supply chain snarls as factories in key areas like China were forced to shutter.
Fed Chair Jay Powell in late March vowed to take strong action against inflation as needed.
Adding to the speculative market environment, a key part of the Treasury yield remained inverted on Monday after 2-year and 10-year Treasury yields shifted last week, heightening concerns about a possible recession coming. While inversions have historically preceded some economic recessions, they are not guaranteed indicators.
Cramer said that energy stocks performed the best during the first quarter due to soaring prices, while “recession-resistant” utility stocks also rallied. Cramer also listed the first quarter’s biggest winning and losing companies that are listed in the Dow Jones Industrial Average, S&P 500 and Nasdaq 100.
Here are the winners and losers:
Dow Jones Industrial Average
Winners
Losers
S&P 500
Winners
Losers
Nasdaq 100
Losers
Disclosure: Cramer’s Charitable Trust owns shares of Chevron, Salesforce, Halliburton, Meta
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LONDON — Two doses of the Oxford-AstraZeneca or Pfizer-BioNTech Covid-19 vaccines are substantially less effective at warding off omicron compared to previous variants of the coronavirus, scientists have found.
However, the researchers were optimistic that a booster shot would improve immunity against the new, highly transmissible variant.
In a new study announced on Monday, researchers from the University of Oxford tested blood samples of people 28 days after their second dose of either vaccine.
When omicron was introduced to those samples, scientists reported “a substantial fall” in the neutralizing antibodies that fight off Covid compared to the immune responses seen against earlier variants.
The research paper noted that some vaccine recipients “failed to neutralize [the virus] at all.”
“This will likely lead to increased breakthrough infections in previously infected or double vaccinated individuals, which could drive a further wave of infection, although there is currently no evidence of increased potential to cause severe disease, hospitalization or death,” the study’s authors said.
The pre-print study, which is yet to be peer reviewed, was published on the MedRxiv server.
Gavin Screaton, head of Oxford University’s Medical Sciences Division and lead author of the paper, said in a press release on Monday that the findings should “press home the message that those who are offered booster vaccination should take it.”
“Whilst there is no evidence for increased risk of severe disease, or death, from the virus amongst vaccinated populations, we must remain cautious, as greater case numbers will still place a considerable burden on healthcare systems,” he warned.
“Vaccination induces many arms of our immune system, including neutralizing antibodies and T-cells,” added co-author Teresa Lambe, a professor of vaccinology at the University of Oxford.
“Real-world effectiveness data has shown us that vaccines continue to protect against severe disease with previous variants of concern. The best way to protect us going forward in this pandemic is by getting vaccines in arms.”
A report published by the U.K.’s Health Security Agency on Friday estimated that two doses of a Covid vaccine were significantly less effective at preventing symptomatic disease through infection from the omicron variant compared to delta. However, the report noted that after a booster dose, vaccines were thought to be 70 to 75% effective at preventing symptomatic infections.
“With previous variants, vaccine effectiveness against severe disease, including hospitalization and death, has been higher than effectiveness against mild disease,” the UKHSA said. “It will be a few weeks before effectiveness against severe disease with Omicron can be estimated, however based on this experience, this is likely to be substantially higher than the estimates against symptomatic disease.”
In a televised statement on Sunday, U.K. Prime Minister Boris Johnson warned Britain faces a “tidal wave” of Omicron infections, and announced that the country would be speeding up its booster program to offer all adults a third dose of a vaccine by the end of the year. The government had previously been aiming to extend its booster scheme to all over-18s by the end of January.
Johnson’s statement came after the chief medical officers of England, Scotland, Wales and Northern Ireland raised the U.K.’s coronavirus threat level to four — the second highest level — in light of the spread of omicron.
Elsewhere, an Israeli study published on Saturday found that a three-dose course of the Pfizer-BioNTech vaccine provided significant protection against the omicron variant. Israel began its booster program in July.
The findings from Israel came after researchers in South Africa found omicron could partially evade the immunity from two shots of the Pfizer-BioNTech vaccine.
The omicron variant, thought to be more infectious than its predecessor delta, was first identified in South Africa in November and has since spread to at least 38 countries around the world and 25 U.S. states.
John O’Neill, 42, from Essex, is ‘trapped in his body’ after being one in 50,000 to suffer an extreme reaction. His family say they aren’t anti-vax and don’t want their story to be hijacked for the campaign
John O’Neill suffered a stroke after the AstraZeneca vaccine
A dad has become ‘trapped in his body’ after a stroke caused by the AstraZeneca vaccine.
John O’Neill, 42, from Essex, is one in 50,000 to suffer an extreme reaction to the Covid vaccine.
The IT engineer was hit with vaccine-induced immune thrombocytopenia and thrombosis (VITT) only nine days after he received his first dose in May, the family wrote on a JustGiving page.
He lived with his 38-year-old wife Vicky and his kids, son Mason, 5, and daughter Freya, 9.
Vicky said: “He’s a nice, genuine guy who would do anything for anyone. “He was happy go lucky and a real family man.”
Vicky warns that her and John are not anti-vaccine and don’t wish for their story to be used to strengthen such arguments, reports EssexLive.
John has asthma, as does Mason, and this meant the O’Neill family were very cautious throughout the Covid lockdowns.
With a lung condition, John was deemed at higher risk if he caught the virus.
So when a vaccine became available earlier in 2021, John and Vicky were eager to get protected.
Vicky says John had feared getting a blood clot from the vaccine
However, as an “IT guy”, Vicky said her husband had done some research about the AstraZeneca vaccine and was quite worried.
John had become concerned that his asthma put him more at risk of extremely rare blood clots as a result of the AZ vaccine.
“On the day we had the vaccine he said he’d have AZ and I’d have Pfizer, so that at least the children will have one of us,” Vicky explained.
“John gets very upset now, because what we were worried about has pretty much happened.”
In May, John was given his first dose of the AZ vaccine and like most people who get vaccinated, John had flu-like symptoms for a few days, which then disappeared.
But several days later John complained of feeling “extremely tired”, before experiencing “uncontrollable shivering”, sickness and pain across his eyes.
Paramedics initially thought the 42-year-old was just having a migraine, however, he continued to feel sick then lost vision in his left eye.
After he was taken to hospital on May 27, Vicky got the news that John had suffered from a stroke.
John ‘was a loving family man before the blood clot’
He was paralysed down the right-hand side of his body after having a clot in his brain and a blocked artery in the left side of his neck.
After being sent to the Royal London Hospital for surgery, doctors didn’t understand what was happening to John.
His blood was clotting in all of his main arteries and Vicky claims it was only at this point that doctors realised it could be linked to the AZ vaccine.
After spending a long period in intensive care, John returned home from hospital, but he was not the same man.
John has lost his vision in his left eye and has “significant” brain damage, so struggles to communicate.
Sometimes John knows what he wants to say, but his brain can’t get the words out.
Vicky says it’s like he’s trapped in his own body.
She explained: “He has significant brain damage, so has to be spoken to slowly.
“He can’t digest information in big groups of people or noisy places.
“He’s improving with his speech and is trying to put sentences together.
“He struggles with reading, writing, numbers and letters.
“He completely knows what he wants to say but his brain can’t process how to get the words out. He finds it frustrating.”
John has improved a lot since returning home thanks to therapy and can now walk on his right leg – which doctors feared they would have to amputate after blood clotted in its artery.
But he still cannot walk very far. The stroke has completely changed his and his family’s life.
Vicky says Mason and Freya are doing “very well”, considering what has happened to their dad, but that the stroke has been “extremely difficult” for the O’Neills as a family.
However, Vicky admits that she’s unsure how to feel about the situation.
“We’re not against the vaccine and we did want it. Even now, we’re unsure but we’re not against people having it.
“We feel extremely let down that the government hasn’t put anything into place for us, as our lives have been completely changed forever.
“How do you survive and keep going?
“I’ve got to be a mother to my children, a full-time carer for my husband and I have bills to pay. I need the support.”
Added to John and Vicky’s tough new life, the couple are still having to contend with the stresses of an ongoing pandemic.
As John was given the AstraZeneca, doctors are unsure how his body would react to other vaccines.
Alongside his asthma, this leaves the 42-year-old virtually unprotected from Covid.
John’s sister has set up a Just Giving page and Vicky admits she has been overwhelmed by the massive £16,376 that’s been donated so far.
“It’s been unbelievable, just unbelievable,” Vicky said.
“Me and my husband were extremely grateful but we find it hard to do things like this.
“We’ve always worked from the moment we came out of college.
“The amounts people are putting on at a time are just amazing and we can’t believe it.”
You can find out more about John’s story and can donate to his family on his Just Giving page.
The new omicron Covid variant poses a greater risk for the unvaccinated and there’s reason to believe that current vaccines are going to be “quite effective,” a former White House advisor said Monday.
“What we know for sure is that it is a dangerous variant for people who have not been vaccinated,” Andy Slavitt told CNBC’s “Squawk Box Asia.”
“What we have to get to learn is whether or not omicron — how it spreads in an environment where delta is strong,” he said.
Slavitt previously served as a senior advisor on President Joe Biden’s coronavirus response team and ran the Centers for Medicare & Medicaid Services under the Obama administration.
What we know about omicron
The omicron strain was first identified by South African scientists and it has been detected in several countries including the United States, the United Kingdom, Australia and Germany.
Health experts are concerned about the omicron variant’s transmissibility given its unusual constellation of mutations and profile that differs from previous variants of concern. Scientists are also trying to figure out how effective current vaccines are in protecting people against any severe illness due to the new strain.
“I think we have good reason to believe that the vaccines are effective, if not as effective, and that with boosters, they’ll be quite effective,” Slavitt told CNBC. “But pharma’s also going back to the drawing board.”
Covid vaccine makers Pfizer, BioNTech, Moderna, Johnson & Johnson and AstraZeneca said they are investigating and testing the omicron variant.
Slavitt said it is possible that there would be updated vaccines available, if needed, in the next several months, before the omicron variant starts to spread meaningfully.
But the main problem that the world currently faces is vaccine inequity. Information compiled by Our World In Data showed just around 44% of the world population has been fully vaccinated against Covid-19. But only a small percentage of people in low-income countries have received at least one dose.
Slavitt explained that it is still too early to tell how omicron will fare compared with the lethal delta strain.
“We get to a point when we have a variant that replaces delta that is not serious or can be easily treated with medication, then that’ll be a very new day for this pandemic. We can knock on wood that happens now, if it’s not with omicron, it’ll may be the next one,” he said, adding that such a scenario could potentially turn Covid more akin to the common cold.
A paramedic prepares doses of AstraZeneca vaccine for patients at a walk-in COVID-19 clinic inside a Buddhist temple in the Smithfield suburb of Sydney on August 4, 2021.
Saeed Khan | AFP | Getty Images
Scientists claim to have discovered a “potential mechanism” that triggers rare blood clots in some people who receive the Oxford-AstraZeneca Covid vaccine.
Links between the vaccine and rare, sometimes fatal, blood clots have prompted some countries to restrict its use to older adults or favor alternative shots.
To be sure, medical experts have repeatedly said the benefits of the vaccine outweigh the risks associated with it, with one study concluding that Covid-19 poses a much bigger threat of blood clots than vaccination.
Scientists from Cardiff University in the U.K. and Arizona State University in the U.S. worked with AstraZeneca to investigate vaccine-induced blood clots, publishing their findings on Wednesday in the journal Science Advances.
The study suggested that the shot’s viral vector — the vaccine ingredient used to transport the coronavirus’ genetic material into a recipient’s cells — could be the issue.
In the Oxford-AstraZeneca vaccine, the viral vector is an adenovirus found in chimpanzees. The adenovirus is engineered to match Covid-19’s spike protein — a key part of its structure used to invade human cells.
Johnson & Johnson’s Covid-19 vaccine also uses an adenovirus to carry spike proteins from the coronavirus into human cells to trigger an immune response and has similarly been linked to rare blood clots.
The team behind the study said they believed the chimpanzee virus used in the Oxford-AstraZeneca vaccine had a specific interaction that could prompt the body’s defenses to act against itself.
According to the study, the viral vector in the Oxford-AstraZeneca vaccine, in rare cases, enters the bloodstream, where it can bind to a protein called platelet factor 4 (PF4).
Once the viral vector has bound to the protein, the immune system views it as foreign, the study’s authors said. “Misplaced immunity” may trigger a release of antibodies against PF4, which then binds to and activates cells that help blood clot, causing those cells to cluster together and generate blood clots.
The study’s authors emphasized that the phenomenon occurs in “a very small number of people.”
Alan Parker, a professor at Cardiff University’s School of Medicine, said if a procedure responsible for the rare vaccine-induced blood clots was established, it may help to prevent and treat the disorder.
“Vaccine-induced immune thrombotic thrombocytopenia [blood clots] only happens in extremely rare cases because a chain of complex events needs to take place to trigger this ultra-rare side effect,” he said in a press release Wednesday.
“We hope our findings can be used to better understand the rare side effects of these new vaccines, and potentially to design new and improved vaccines to turn the tide on this global pandemic.”
Here are the most important news, trends and analysis that investors need to start their trading day:
1. Dow set to rise slightly after strong earnings failed to inspire
Traders work on the floor of the New York Stock Exchange in New York.
Michael Nagle/Bloomberg via Getty Images
2. Macy’s, Kohl’s shares jump on strong quarterly results
Macy’s shares surged more than 10% in premarket trading after the department store chain on Thursday blew away estimates for fiscal third-quarter earnings. Revenue also topped what analysts had forecast. Macy’s raised its full-year outlook ahead of the holidays. Macy’s stock has rallied more than 174% year to date to over $30 per share. However, that’s nowhere near its all-time high of nearly $73 per share in July 2015.
Shares of Kohl’s, up nearly 40% already in 2021, were indicated to add 9% before they open for trading on Wall Street. The department store chain Thursday also reported much better-than-expected fiscal third-quarter earnings. Revenue also beat estimates. Kohl’s raised its full-year forecast. The stock saw a sharp decline from loftier levels in 2018 into the pandemic before recovering.
3. Nvidia, Cisco shares go in opposite directions after earnings
Shares of Nvidia soared 8% in the premarket, a gain that would move the tech giant closer to an $800 billion stock market value. After the bell on Wednesday, the company reported a 60% year-over-year increase in adjusted quarterly earnings per share and a 50% year-over-year rise in revenue. Both measures exceeded expectations. Shares of Nvidia, as of Wednesday’s close, have soared 124% in 2021.
Dow stock Cisco Systems, up nearly 27% in 2021 as of Wednesday’s close, fell more than 6% in the premarket, the morning after the computer networking firm missed on quarterly revenue and issued weaker-than-expected forward guidance. Cisco CEO Chuck Robbins blamed supply constraints. The company did beat estimates for earnings per share for the three months ended on Oct. 30.
4. AstraZeneca says Covid antibody drug over 80% effective
AstraZeneca says its cocktail of antibodies, AZD7442, has given results deemed positive against Covid-19 during phase III clinical trials.
AstraZeneca’s antibody drug has been shown to be highly effective at preventing Covid in people who may not respond well to vaccines, according to new clinical trial results. Patients given a single injection of the treatment were 83% less likely to develop symptomatic cases of the coronavirus than participants who were given a placebo. More than three-quarters of participants in the trial had underlying conditions that put them at high risk of contracting severe Covid.
5. Deere workers approve contract offer, will end strike
Workers picket outside of John Deere Harvester Works facility on October 14, 2021 in East Moline, Illinois.
Scott Olson | Getty Images
Deere & Co. workers approved a new contract late Wednesday, delivering 10% raises immediately and ending a monthlong strike for more than 10,000 employees. The United Auto Workers union said 61% of its members approved the latest deal with the tractor maker, even though the new offer was strikingly similar to one that a majority of workers rejected two weeks ago. Shares of Deere rose nearly 2% in Thursday’s premarket. The stock has gained around 30% in 2021.
— The Associated Press contributed to this report. Follow all the market action like a pro on CNBC Pro. Get the latest on the pandemic with CNBC’s coronavirus coverage.
A healthcare worker shows a vial containing doses of COVAXIN, a coronavirus (COVID-19) vaccine, manufactured by Bharat Biotech, at a vaccination centre, in New Delhi, India on July 3, 2021.
Mayank Makhija | NurPhoto | Getty Images
The World Health Organization on Wednesday said it had approved Indian drugmaker Bharat Biotech’s Covid-19 vaccine for emergency use, paving the way for the homegrown shot to be accepted as a valid vaccine in many poor countries.
The emergency use listing would allow Bharat Biotech to ship the shot known as Covaxin to countries that rely on WHO guidance for their regulatory decisions. It could also help millions of Indians who have received the shot to travel outside the country.
The WHO tweeted its technical advisory group had ruled that Covaxin’s benefits significantly outweighed the risks and that it met WHO standards for protection against Covid-19.
The advisory group was expected to make a decision on Covaxin last week, but had asked for additional clarifications from Bharat Biotech before conducting a final risk-benefit assessment for the vaccine’s global use.
Covaxin was also reviewed by the WHO’s Strategic Advisory Group of Experts on Immunization, which recommended its use in two doses, with an interval of four weeks, in all age groups 18 and above.
A health worker administers a dose of the Bharat Biotech Ltd. Covaxin vaccine at a Covid-19 vaccination center set up at the Delhi Municipal Corp. Public Health Center in the Daryagunj area of New Delhi, India, on Monday, June 21, 2021.
Sumit Dayal | Bloomberg | Getty Images
Bharat Biotech’s vaccine is the seventh to win WHO backing following two mRNA shots from Pfizer/BioNTech and Moderna, adenovirus vector vaccines developed by AstraZeneca and Johnson & Johnson, and China’s inactivated vaccines from Sinovac Biotech and Sinopharm.
The WHO’s approval may also clear the way for India to commit supplies to the COVAX global vaccine sharing effort, which is co-led by the WHO and aims to provide equitable access to shots for low- and middle-income countries.
Last month, Reuters reported the country was delaying a deal on that while the WHO considered the Covaxin shot for approval.
Bharat Biotech, which developed Covaxin with an Indian state research body, started sharing data with the WHO from early July.
Shares of Bharat Biotech’s U.S.-based partner Ocugen jumped over 6% in pre-market trading after the WHO’s decision.
Former Obama White House policy director Dr. Kavita Patel explained why the surging number of Covid cases in the United Kingdom could be a compelling argument for booster shots.
“What’s happening is … this real world experiment where the efficacy of AstraZeneca is decreasing, and they haven’t rolled out their boosters,” Patel said during a Tuesday evening interview on CNBC’s “The News with Shepard Smith.” “It’s an argument for boosters, and a pretty compelling one.”
The U.K.’s early vaccination rollout began in December 2020 and was one of the first in the world. Now, however, it is seen as contributing to its high case rate, due to an increasing body of data that shows immunity in vaccinated people wanes after about six months.
The spread of the much more infectious delta Covid variant in the spring and summer is also seen as a factor that has diminished vaccine efficacy.
In September the U.K. began rolling out booster shots to the over-50s, medical staff and anyone with underlying health conditions. Those who received their second dose at least six months ago are being asked to come forward first. Currently around 6.5 million people in England are eligible for a booster, with the NHS so far having administered around 3.6 million booster shots, data shows.
Patel told host Shepard Smith that she’s also been keeping an eye on the Covid strain that’s potentially contributing to the U.K. having one of the worst daily infection rates in the world.
“We’re watching, kind of, a sub-lineage of the delta strain, something very specific that is growing in percentage in the U.K … there is a potential that it is more transmissible than delta, which makes it easier to be even more infectious than delta,” said Patel.
In the United States, the New York Times reported that the Food and Drug Administration is expected to clear Johnson & Johnson and Moderna boosters and allow mix-and-match shots this week.