Tag Archives: Biotech and Pharmaceuticals

India could play an important role in producing vaccines

A medic holds Covid-19 vaccine Covaxin vials during the countrywide inoculation drive, in Jaipur, Rajasthan, India, Saturday, Feb. 6, 2021.

Vishal Bhatnagar | NurPhoto | Getty Images

India could become the world’s second largest Covid vaccine maker, and analysts say the country has the capacity to produce for both its own population and other developing countries.

Most of the world’s vaccines have historically come from India. Even before Covid-19, the South Asian country produced up to about 60% of the world’s vaccines — and can do so at a relatively low cost.

“India has been a manufacturing hub for vaccines … even before the pandemic, and should therefore be a strategic partner in the global inoculation against COVID-19,” JPMorgan analysts wrote in a report last month.

Consulting firm Deloitte predicts that India will be second only to the U.S. in terms of coronavirus vaccine production this year. PS Easwaran, a partner at Deloitte India, said more than 3.5 billion Covid vaccines could be made in the country in 2021, compared to around 4 billion in the U.S.

Furthermore, companies in India are currently scaling up production to meet demand.

“We are expanding our annualized capacities to deliver 700 million doses of our intramuscular COVAXIN,” said Indian firm Bharat Biotech, which developed a Covid vaccine together with the state-run Indian Council of Medical Research.

Covaxin has been approved for emergency use in India, but has been mired in controversy due to criticism that there was a lack of transparency in its approval, and also because it hasn’t published enough efficacy data.

India vaccines suitable for developing world

Another vaccine — known as Covishield in India and co-developed by AstraZeneca and the University of Oxford — has also been granted emergency approval in India. It is being produced locally by the Serum Institute of India (SII).

According to Reuters, SII makes around 50 million doses of Covishield every month, and plans to increase production to 100 million doses a month by March.

Other Indian companies have agreed to produce vaccines for developers such as the Russian Direct Investment Fund and U.S. firm Johnson & Johnson. To be clear, these vaccine candidates have not been approved for use yet.

“Even without successful vaccine development from their own pipelines, available capacity provides opportunity to partner as contract manufacturers with approved vaccine developers to meet supply needs particularly for India and other [emerging markets],” the JPMorgan report said.

With a proven track record on the scale at which vaccines are produced, India should be able ramp up production to meet international demand as well.

Nissy Solomon

Centre for Public Policy Research

India’s vaccines will likely be more suitable for developing countries, said K Srinath Reddy, president of the Public Health Foundation of India.

Some of the leading vaccines right now, such as the ones from Pfizer-BioNTech and Moderna, make use of messenger RNA technology (mRNA) which uses genetic material to trigger the body’s own infection-fighting process.

Those vaccines require “stringent cold chain requirements” that will be difficult, or even “out of the realm of possibility,” for most health systems, Reddy said.

Vaccines made in India are easier to transport and cheaper, putting the country in a better position than the U.S. and Europe when it comes to meeting demand in the developing world, he added.

India’s ‘proven record’

India’s huge production capacity also gives analysts confidence that the country can provide vaccines to other nations.

New Delhi has pledged to send vaccines to its neighboring countries, and has already supplied 15.6 million doses to 17 countries, according to Reuters.

“India’s manufacturing capabilities are sufficient to meet domestic demand,” said Nissy Solomon, a senior research associate at Centre for Public Policy Research (CPPR).

“With a proven track record on the scale at which vaccines are produced, India should be able ramp up production to meet international demand as well,” she told CNBC.

Solomon added that the country monitors domestic needs before making decisions on exports.

Bharat Biotech, for its part, said it is “fully prepared to meet the needs of India and global public health.”

Challenge of storing, distributing vaccines

However, there will be challenges as the country seeks to meet the vaccine demand in India and beyond.

Jefferies equity analyst, Abhishek Sharma, wrote in a note that the rollout of vaccines in India has been slow. Even under the assumption that the speed of vaccinations will increase, Sharma estimates that only 22% of India’s 1.38 billion population can be vaccinated in a year.

That’s roughly the number of people India wants to inoculate by July or August.

“The supply of vaccines is not as much a problem as that of storage, distribution and vaccine uptake,” said CPPR’s Solomon.

“India lacks the capacity to store and distribute to the masses at a scale as big as this,” she said, adding that the country should “strategically” choose vaccines that do not have to be stored at extreme temperatures.

I would say that [these challenges are] more like speed breakers which will slow down the … program, rather than actual roadblocks which require the program to stop.

K Srinath Reddy

Public Health Foundation of India

The vaccines that India currently manufactures require normal refrigeration, but those produced by Pfizer-BioNTech need to be kept in extremely cold temperatures of minus 70 degrees Celsius (minus 94 degrees Fahrenheit), while those by Moderna have to be stored at minus 20 degrees Celsius (minus 4 degrees Fahrenheit).

The “real challenge” is in the sheer number of people who need to be vaccinated, said Reddy from the Public Health Foundation of India.

“This is the first time that an adult immunization program is being undertaken at such an unprecedented scale,” he told CNBC.

He said immunization programs typically focus on vaccinating children and mothers, and logistics network may not be prepared to handle vaccines for entire populations.

Reddy suggested that existing cold chain for food products could be used for vaccines, and was hopeful that this problem could be resolved.

“I would say that [these challenges are] more like speed breakers which will slow down the … program, rather than actual roadblocks which require the program to stop,” he said.

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Medical experts try to establish ‘long Covid’ diagnosis for patients with lasting symptoms

Critical care workers insert an endotracheal tube into a coronavirus disease (COVID-19) positive patient in the intensive care unit (ICU) at Sarasota Memorial Hospital in Sarasota, Florida, February 11, 2021.

Shannon Stapleton | Reuters

Some Covid-19 patients are experiencing shortness of breath, fatigue, headaches and “brain fog” for months to nearly a year after their initial illness. Now, global medical experts are working to better diagnose and treat them for what they are tentatively calling “long Covid.”

Earlier this week, the World Health Organization hosted a global meeting with “patients, clinicians and other stakeholders” to advance the agency’s understanding of what’s medically referred to as post-Covid condition, also known as long Covid, WHO Director-General Tedros Adhanom Ghebreyesus said on Friday.

The gathering was the first of many to come. The goal will be to eventually create an “agreed clinical description” of the condition so doctors will be able to diagnose and effectively treat patients, he said. Given how many people have been infected with the virus globally — nearly 108 million people as of Friday — Tedros warned it’s likely many will experience these lingering symptoms.

“This illness affects patients with both severe and mild Covid-19,” Tedros said during a press briefing at the agency’s headquarters in Geneva. “Part of the challenge is that patients with long Covid could have a range of different symptoms that can be persistent or can come and go.”

Limited data

So far, there’s a limited number of studies that discern what the most common long-Covid symptoms are or how long they might last. Most of the focus has been on people with a severe or fatal illness, not those who have recovered but still report lingering side effects, sometimes referred to as “long haulers.”

Most Covid patients are thought to recover just weeks after their initial diagnosis, but some have experienced symptoms for six months, or even close to a year, medical experts say.

One of the largest global studies of long Covid published in early January found that many people suffering from ongoing illness after infection are unable to return to work at full capacity six months later. The study, which was published on MedRxiv and not peer-reviewed, surveyed more than 3,700 people ages 18 to 80 from 56 countries to identify the symptoms.

The most frequent symptoms experienced after six months were fatigue, tiredness after exercise and cognitive dysfunction, sometimes referred to as brain fog, the study found.

Is this unique to Covid-19?

“We really don’t know what’s causing these symptoms. That’s a major focus of the research right now,” Dr. Allison Navis, a professor at the Icahn School of Medicine at Mount Sinai, said during a call with the Infectious Diseases Society of America on Friday.

“There’s a question of whether this is something that’s unique to Covid itself — and it’s the Covid virus that’s triggering these symptoms — or if this could be part of a general post-viral syndrome,” Navis said, adding that medical experts see similar long-term symptoms after other viral infections.

Another study published in early January in the medical journal The Lancet studied 1,733 patients who were discharged from a hospital in Wuhan, China, between January and May of last year. Of those patients, 76% reported at least one symptom six months after their initial illness. The proportion was higher in women.

“We found that fatigue or muscle weakness, sleep difficulties, and anxiety or depression were common, even at 6 months after symptom onset,” researchers wrote in the study.

They noted that the symptoms reported months after someone’s Covid-19 diagnosis were consistent with data that was previously found in follow-up studies of Severe Acute Respiratory Syndrome, or SARS, which is also a coronavirus.

Post-Covid clinics come online

Some large medical centers are now creating post-Covid clinics to help care for patients with persistent symptoms. Navis said her clinic at Mount Sinai in New York City has treated a “fairly even” distribution of men and women experiencing lingering illness, and the average patient age is 40, she said.

Dr. Kathleen Bell, a professor at the University of Texas Southwestern Medical Center, said her hospital’s long-term Covid-19 clinic started last April as a wave of infections hit Italy and New York early in the pandemic.

Bell, speaking on the Infectious Diseases Society of America call Friday, said that a range of professionals are required to staff the clinics since the symptoms are uneven, including experts who can treat muscle weakness, heart-related illnesses and cognitive issues for those experiencing mental health problems after their diagnosis.

“It’s really, in many ways, forcing us all to get together and to make sure we have open lines of communication to be addressing all of these problems for patients,” Bell said.

Bell added that the Centers for Disease Control and Prevention hosted a call with long Covid centers across the country in January to discuss their model for treating patients.

“I do think that the CDC now is trying to pull centers together and get some some more firm guidelines for this, which is very exciting,” Bell said.

— CNBC’s Sam Meredith contributed to this report.

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Roche arthritis drug reduces death in hospitalized patients with severe Covid, Oxford researchers say

A pharmacist displays a box of tocilizumab, which is used in the treatment of rheumatoid arthritis, at the pharmacy of Cambrai hospital, France, April 28, 2020.

Pascal Rossignol | Reuters

A drug used to treat people with rheumatoid arthritis appears to reduce the risk of death in hospitalized patients with severe Covid-19, especially when it was combined with the steroid dexamethasone, researchers at the University of Oxford said Thursday.

Oxford researchers also found tocilizumab, an intravenous drug manufactured by a division of Swiss drugmaker Roche, also shortened patients’ length of stay at hospitals and reduced the need for a ventilator. The study was part of the RECOVERY trial, which has been testing a range of potential treatments for Covid-19 since March.

“Previous trials of tocilizumab had shown mixed results, and it was unclear which patients might benefit from the treatment,” Peter Horby, a professor at the University of Oxford and joint chief investigator for RECOVERY, said in a statement. “We now know that the benefits of tocilizumab extend to all COVID patients with low oxygen levels and significant inflammation.”

A total of 2,022 patients were randomly selected to receive tocilizumab, which is marketed under the brand name Actemra, by intravenous infusion and were compared with 2,094 patients randomly selected to receive standard care alone. The researchers said 82% of the patients were also taking a steroid such as dexamethasone, another drug that has been found to reduce deaths in the sickest Covid-19 patients.

Researchers said 596 patients in the tocilizumab group died within 28 days compared with 694 patients in the standard care group. That means for every 25 patients treated with tocilizumab, “one additional life would be saved,” Oxford researchers said.

The drug increased the probability of discharge within 28 days from 47% to 54%, according to the researchers. The benefits were seen in all patients, including those requiring mechanical ventilators in an intensive care unit, they added. Among patients not on a ventilator before entering the trial, tocilizumab reduced the chance of progressing to invasive mechanical ventilation or death from 38% to 33%, the researchers said.

The researchers said using tocilizumab in combination with dexamethasone appears to reduce mortality by about one third for patients requiring oxygen and nearly one half for those requiring a ventilator.

Results from the Oxford study have not yet been published in a peer-reviewed journal.

Public health officials and infectious disease experts say world leaders will need an array of drugs and vaccines to end the pandemic, which has infected more than 107.4 million people and killed at least 2.3 million in a little over a year, according to data compiled by Johns Hopkins University.

In the U.S., the Food and Drug Administration has approved Gilead Sciences’ antiviral drug remdesivir as a treatment for for Covid-19 patients at least 12 years old and requiring hospitalization.

The FDA has authorized the use of two monoclonal antibody treatments as well as two vaccines – from Pfizer and Moderna. A third vaccine, from Johnson & Johnson, is expected to be authorized by the FDA as early as this month.

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Dr. Fauci on why it’s important to wear a mask after getting your Covid vaccine

Sergeant Jennifer Callender (L) of the Illinois Air National Guard administers a Pfizer Covid-19 vaccine to Virginia Persha at a vaccination center established at the Triton College in River Grove, Illinois, on February 3, 2021.

Kamil Krzaczynski | AFP | Getty Images

The deployment of life-saving coronavirus vaccines brings hope that life will soon return to a time before the pandemic where we weren’t advised to wear a mask nearly everywhere we go.

But even if you’re one of the lucky few to have gotten a Covid-19 shot, it will be important to continue wearing a face covering until researchers can determine whether the vaccines prevent people from spreading the virus to others who aren’t vaccinated, White House health advisor Dr. Anthony Fauci said Thursday.

“Currently, we do not have enough data to be able to say with confidence that the vaccines can prevent transmission,” Fauci said in a tweet during an online Q&A session. “So even if vaccinated, you may still be able to spread the virus to vulnerable people.”

What the vaccines’ clinical trials have shown, however, is that the drugs are highly effective at preventing symptomatic infections in people who have been inoculated. Both Pfizer-BioNTech’s and Moderna’s vaccines, the only two in the U.S. that have received emergency authorization so far, have proven to be roughly 95% effective at preventing symptomatic infection in people given two doses spread out weeks apart.

Johnson & Johnson’s vaccine, a one-dose jab that has yet to be granted the same authorization from the federal government, reported on Friday that its vaccine was 66% effective overall in protecting against Covid-19 in clinical trials. While lower than the others, it’s still above the threshold the federal government set — roughly 50% — to be granted emergency authorization.

On top of that, the company’s drug was 85% effective in preventing people from becoming severely ill with Covid-19 four weeks after their shot. The vaccine from J&J could become available in March if it clears the U.S. Food and Drug Administration’s standards for emergency use, Fauci said.

Fauci, the director of the National Institute of Allergy and Infectious Diseases, also urged people to accept whichever vaccine available to them once it’s their turn.

Researchers are currently collecting follow-up data from people who participated in clinical trials to determine whether the amount of virus they carry in their nose is reduced after vaccination, or if there’s “significantly fewer” cases where people don’t exhibit any symptoms over the course of their infection.

That would indicate “a decreased ability to transmit the virus following vaccination,” Fauci said.

Read more: As new Covid vaccines near U.S. debut, here’s what you need to know about the shots

Masks, combined with other measures like frequent hand washing and social distancing, have been a critical tool to suppress the spread of Covid-19, medical experts have maintained.

The virus spreads from person-to-person through respiratory droplets that travel through the air when someone talks, coughs, sneezes, sings, or shouts, according to the Centers for Disease Control and Prevention. Face coverings serve as a barrier that can prevent those droplets from spraying to others.

There’s now evidence that the masks could also give the wearer some protection from the virus, the CDC says, though how well it works likely depends on the type of mask.

It’s also important to remember that most Americans haven’t been vaccinated yet, said Dr. Joshua Barocas, a professor at the Boston University School of Medicine. According to recent data from the CDC, just nearly 34 million doses of vaccine have been administered so far.

“We don’t know who’s unvaccinated. We don’t wear it like a badge on our coat. We don’t wear our immune function, we don’t show our risk factors on our shirts,” Barocas said during a call organized by the Infectious Diseases Society of America on Wednesday. “We need a continued multilayered approach.”

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UK trial experiments with mixing Covid vaccines

Empty vials of the Pfizer COVID-19 vaccine are seen at a first come first serve drive-thru vaccination site operated by the Lake County Health Department on January 28, 2021 in Groveland, Florida.

Paul Hennessy | NurPhoto | Getty Images

LONDON — A trial is being launched in the U.K. to explore whether using different Covid-19 vaccines for the first and second doses works in a bid to make nationwide vaccination programs more flexible.

The trial, being led by the University of Oxford and run by the National Immunisation Schedule Evaluation Consortium, will evaluate the feasibility of using a different vaccine for the initial “prime” vaccination to the follow-up “booster” vaccination. 

It is hoped the study will help policymakers understand whether mixing different Covid vaccines could be a viable route to increase the flexibility of vaccination programs and whether it could even provide better protection.

“If we do show that these vaccines can be used interchangeably in the same schedule this will greatly increase the flexibility of vaccine delivery, and could provide clues as to how to increase the breadth of protection against new virus strains,” Matthew Snape, chief investigator on the trial and associate professor in Paediatrics and Vaccinology at the University of Oxford, said on Thursday.

The trial, which is formally known as the “COVID-19 Heterologous Prime Boost study” but has been dubbed the “Com-Cov” study, will recruit over 800 volunteers aged 50 and above in England to evaluate the four different combinations of prime and booster vaccination.

It will trial a first dose of the Oxford-AstraZeneca vaccine followed by boosting with either the Pfizer-BioNTech vaccine or a further dose of the Oxford-AstraZeneca vaccine. The research will also look at a first dose of the Pfizer-BioNTech vaccine followed by boosting with either the Oxford-AstraZeneca vaccine, or a further dose of the Pfizer-BioNTech vaccine. 

These will be evaluated at two different dosing schedules: at a four-week interval to give an early interim data readout, and at a 12-week interval. This latter dosing interval is the current U.K. vaccination policy: A delay in the second dose means more people can get their first vaccines sooner amid a tight supply of shots.

Although the policy has been seen to be controversial, with some experts worrying that it could make the vaccines in use in the U.K. less effective; so far only the University of Oxford-AstraZeneca and Pfizer-BioNTech candidates are in use, with the Moderna shot set to be added to the basket of vaccines in use later in spring.

However, the University of Oxford published a study on Wednesday in which it showed that a delay of 12 weeks between the first and second doses of the AstraZeneca jab increases the efficacy of the vaccine.

The researchers found that the shot was 76% effective at preventing symptomatic infection for three months after a single dose, and that the efficacy rate rose to 82.4% when there was at least a 12-week interval before the second dose. When the second dose was given less than six weeks after the first one, the efficacy rate was 54.9%.

How the Com-Cov study will work

In the latest “Com-Cov” study, researchers will collect blood samples from trial volunteers and will monitor the impact of different dosing regimens on participants’ immune responses, as well as looking for any additional adverse reactions to the new combinations of vaccines.

The study will last for 13 months and has been backed by £7 million ($9.5 million) of government funding from the Vaccines Taskforce, which was set up by the U.K. last April to co-ordinate efforts to research and produce a coronavirus vaccine.

Professor Snape said the study was “tremendously exciting,” before adding that “it will provide information vital to the rollout of vaccines in the U.K. and globally.”

Richer countries are scrambling to vaccinate as many people as possible as national lockdowns, aimed to limit the spread of infections and prevent hospitals from being overrun, damage economies.

The U.K. has been hit hard by the pandemic and has seen cases surge in the winter, aided by a more virulent variant of the virus that emerged in southeastern England that has now become a dominant strain in the country.

The U.K. has the fourth-highest number of cases in the world at present, with over 3.8 million confirmed infections, according to a tally from Johns Hopkins University, and has recorded 109,547 deaths.

The U.K. government was quick to pre-order coronavirus vaccines from a variety of makers early on last year, and to approve the vaccines currently in use. Its vaccination program has been widely praised for its agility and reach, and it’s on target to have vaccinated 15 million people in its top four priority groups, including health and care workers, the elderly and over-70s and anyone deemed extremely clinical vulnerable, by mid-February.

The latest government data, as of Wednesday, shows that just over 10 million people have had their first vaccine dose, and just under 500,000 have had a second dose, too. The Oxford-AstraZeneca vaccine, which is produced in Britain, makes up the bulk of the U.K.’s vaccination program.  

Deputy Chief Medical Officer and Senior Responsible Officer for the study, Professor Jonathan Van-Tam, said that the research could even show that alternating vaccines could enhance the level of antibodies needed to fight potential Covid-19 infection.

“It is also even possible that by combining vaccines, the immune response could be enhanced giving even higher antibody levels that last longer; unless this is evaluated in a clinical trial we just won’t know. This study will give us greater insight into how we can use vaccines to stay on top of this nasty disease,” he said.

The U.K.’s vaccines minister Nadhim Zahawi told the BBC on Thursday that, for now, the country’s vaccination program will continue as normal: “At the moment we will not change anything at all,” Zahawi told the ‘Today’ program.

“If you’ve had a Pfizer BioNTech vaccine for your first dose, you’ll have a Pfizer BioNTech vaccine for your second.  If you’ve had Oxford-AstraZeneca, you’ll have Oxford-AstraZeneca for your second dose.”

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CDC director says schools can safely reopen without vaccinating teachers

Rochelle Walensky, who has been nominated to serve as director of the Centers for Disease Control and Prevention, speaks after US President-elect Joe Biden announced his team tasked with dealing with the Covid-19 pandemic at The Queen in Wilmington, Delaware on December 8, 2020.

Jim Watson | AFP | Getty Images

Teachers do not need to get vaccinated against Covid-19 before schools can safely reopen, the head of the Centers for Disease Control and Prevention said Wednesday.

“There is increasing data to suggest that schools can safely reopen and that safe reopening does not suggest that teachers need to be vaccinated,” CDC Director Rochelle Walensky told reporters during a White House press briefing on Covid-19.

“Vaccinations of teachers is not a prerequisite for safely reopening schools,” she added.

The CDC’s Advisory Committee on Immunization Practices voted to put “frontline essential workers,” which include teachers, next in line to receive a Covid-19 vaccine after first prioritizing health-care workers and long-term care facility residents. However, it may take a while for most teachers to get their shots as U.S. officials work to pick up the pace of vaccinations.

Still, school systems across the U.S. have been under pressure to reopen after shifting to remote learning last year due to the coronavirus pandemic, which has infected more than 26.4 million Americans and killed at least 447,077 in a little over a year.

Some parents have been forced to stay at home to watch their children instead of going to work. Meanwhile, teachers and other faculty have expressed concerns about returning to school, potentially put their health at risk.

A study from the CDC published late last month found little evidence of the virus spreading at schools in the U.S. and abroad when precautions were taken, such as wearing masks, social distancing and ventilating rooms.

The Biden administration has released a Covid rescue plan that includes providing schools and universities $170 billion to reopen. The money would be used in part to scale up testing. The administration has said testing is a “critical” strategy for controlling the spread of the virus, but added tests are still not widely available, and the U.S. is still not using the ones it has effectively.

Walensky has previously said that schools should be the first to open and the last to close in the pandemic.

Jeff Zients, President Joe Biden’s Covid-19 czar, said Wednesday that Biden has been “very clear” that he wants schools to “reopen and to stay open.”

“That means every school has the equipment and the resources to open safely,” he said during the press briefing, urging Congress to “do its part” by passing Biden’s Covid rescue plan. “Not just private schools or schools in wealthy areas but all schools.”

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There will be enough Covid vaccines for the ‘entire U.S. adult population by June,’ doctor says

Johnson & Johnson board member Dr. Mark McClellan told CNBC Friday that there could be enough vaccinations for the entire U.S. adult population by the summer. 

“Assuming all of the close review of the J&J data all pans out, we’re going to have the capacity between Moderna, Pfizer, J&J, to have enough vaccines available by June for the entire U.S. adult population,” McClellan, a former FDA commissioner, said on “The News with Shepard Smith.” 

The U.S. plans to buy 200 million Covid vaccine doses from Moderna and Pfizer. The Department of Health and Human Services will boost its vaccine supply to states from 8.6 million to a minimum of 10 million doses per week. So far, states have received more than 49 million doses, but only about half of those have actually ended up in people’s arms, according to the Centers for Disease Control and Prevention. The agency reports that the U.S. is administering a little more than a million shots every day.

McClellan that the U.S. should significantly increase the amount of shots administered per day and “get our capacity for doing vaccinations up closer to 3 million doses per day.”

The United States has ordered 100 million doses of the J&J vaccine, which the company plans to deliver by June. J&J plans to file for emergency use authorization next week. If J&J’s vaccine is authorized by the FDA, it would be the third vaccine approved for emergency use in the U.S. Pfizer’s vaccine was authorized by the FDA on Dec. 11, and Moderna’s was authorized a week later.

The J&J vaccine efficacy numbers were lower than those for Pfizer and Moderna. Pfizer’s vaccine was found to be 95% effective against preventing Covid-19, while Moderna’s was found to be about 94% effective. J&J’s vaccine was found to be 66% effective overall in preventing moderate to severe Covid.

Host Shepard Smith asked McClellan about the lower efficacy numbers compared to Pfizer and Moderna, and he explained to Smith that “we’re fighting a different virus today than we were three months ago when previous trials were done.”

Additionally, J&J ran its trial across three continents and the level of protection varied by region. Its vaccine demonstrated overall, 72% effectiveness in the United States and 66% in Latin America. In South Africa, where the dangerous B.1.351 strain of Covid caused a surge in cases, the J&J  vaccine demonstrated 57% effectiveness.

“Unfortunately, we’re probably going to be fighting a different virus three months from now, so most important in winning this battle, is getting as many people vaccinated as possible,” said McClellan. “The faster we get shots in arms, the more people we get vaccinated here in this country and around the world, the better we’re going to do in containing that further spread and the further damage from Covid.”

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Novavax says drug is more than 89% effective

Biotech firm Novavax said Thursday that its coronavirus vaccine was more than 89% effective in protecting against Covid-19 in its phase three clinical trial conducted in the United Kingdom.

The results were based on 62 confirmed Covid-19 infections among the trial’s 15,000 participants. The company said 56 cases were observed in the placebo group versus six cases observed in the group that received its vaccine. That resulted in an estimated vaccine efficacy of 89.3%, it said.

Shares of the company were up more than 23% in after-hours trading.

With the results, the company “has the potential to play an important role in solving this global public health crisis,” Novavax CEO Stanley Erck said in a statement. “We look forward to continuing to work with our partners, collaborators, investigators and regulators around the world to make the vaccine available as quickly as possible.”

The study also found that the vaccine appeared to be 85.6% effective against the U.K. variant, also known as B.1.1.7. A separate phase two study in South Africa showed that the vaccine isn’t nearly as effective against a new strain ravaging that country.

The shot was still considered effective in protecting against the virus, but at an efficacy rate of just 49.4% among 44 Covid-19 cases in South Africa, where 90% of the cases contain the troubling new variant, the company said.

As a result of the lower effectiveness against the strain in South Africa, Novavax said it plans to pick a modified version of the vaccine to better guard against the new strain “in the coming days.” It plans to test the modified vaccine in the second quarter of this year.

Novavax is among several companies developing a vaccine to fight the virus, which has infected more than 101 million people worldwide and killed at least 2.2 million as of Thursday, according to data compiled by Johns Hopkins University. Only two vaccines — from Pfizer and Moderna — have been authorized for use in the U.S. so far.

In July, the U.S. government, as part of the Trump administration’s Operation Warp Speed initiative, announced it would pay Novavax $1.6 billion to develop and manufacture the potential vaccine, with the aim of delivering 100 million doses by the beginning of 2021.

It’s unclear if the data Thursday will be enough for Novavax to be given an emergency use authorization by the Food and Drug Administration that would allow the distribution in the U.S. The company began a late-stage trial with 30,000 people in the U.S. and Mexico in late December.

Novavax’s vaccine contains synthesized pieces of the surface protein the coronavirus uses to infect humans. The company said the vaccine was well tolerated, adding that “severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups.”

In August, the company said phase one trial data found its vaccine generated a promising immune response. Participants received two doses of the potential vaccine via intramuscular injection approximately 21 days apart. Novavax also said the vaccine was well tolerated with no serious adverse events reported.

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