Tag Archives: BioNTech SE

Pfizer wants to store vaccine at higher temperatures, making deliveries easier

FRANKFURT (Reuters) – Pfizer Inc and BioNTech SE have asked the U.S. health regulator to relax requirements for their COVID-19 vaccine to be stored at ultra-low temperatures, potentially allowing it to be kept in pharmacy freezers, they said on Friday.

Approval by the Food and Drug Administration (FDA) could send a strong signal to other regulators around the world that may ease distribution of the shot in lower-income countries.

The companies have submitted new temperature data to the FDA to support an update to the current label that would allow vials to be stored at -25 to -15 degrees Celsius (-13°F to 5°F) for a total of two weeks.

The current label requires the vaccine to be stored at temperatures between -80ºC and -60ºC (-112ºF to -76ºF), meaning it has to be shipped in specially designed containers.

The shot’s cold-storage requirements set off a scramble among U.S. states at the beginning of the rollout for dry ice, in which it can be stored temporarily when there are no specialized freezers available, for instance in rural areas.

Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security, said the higher temperatures should “greatly expand the ability to use this vaccine in many parts of the world (or even the U.S.) that do not have the capacity for deep freeze storage”.

Pfizer/BioNTech’s vaccine, along with Moderna Inc’s two-dose shot, has already won U.S. emergency-use authorization and is being widely distributed as part of the country’s mass vaccination efforts.

The update from the drugmakers comes as two studies from Israel found that the vaccine greatly reduced virus transmission, and the shot was backed by two of the South African government’s top advisers.

The new data also will be submitted to global regulatory agencies within the next few weeks, the two companies said.

A BioNTech spokeswoman declined to provide more details on the timing and which agencies would be contacted.

“The data submitted may facilitate the handling of our vaccine in pharmacies and provide vaccination centers an even greater flexibility,” BioNTech Chief Executive Ugur Sahin said.

Deutsche Post, which has shipped COVID-19 vaccines to several European countries, Israel, Bahrain, Mexico and Singapore, among other states, said -25 degrees would provide some relief but transportation would still not be easy.

A spokeswoman said air freight would likely no longer require dry ice on board, increasing storage capacity per plane.

BioNTech has said it imposed long-term storage and transportation requirements of -70 degrees out of caution because it had started stability and durability tests on its vaccine relatively late.

Even though it launched its COVID-19 vaccine development program as early as January 2020, working on four compounds in parallel, it did not decide until July which of the four to proceed with, and only then started stability tests.

If approved, the less onerous storage requirements would provide significant logistical relief.

The World Health Organization’s COVAX global vaccine-sharing program has so far limited distribution of Pfizer-BioNTech vaccines to just a few countries, partly out of concern over a lack of infrastructure in developing nations.

The WHO said it was hopeful that eased requirements could broaden its reach.

“We are aware of reports of this and look forward to seeing the data. If proven correct, this could make rollout of the vaccine easier in all countries, and particularly in low-income ones,” it said.

Moderna’s product, which like Pfizer’s is based on so-called messenger RNA molecules, is already cleared for storage at -25 to -15 degrees Celsius.

(Reporting by Manojna Maddipatla and Ankur Banerjee in Bengaluru, Ludwig Burger in Frankfurt, John Miller in Zurich, Matthias Inverardi in Duesseldorf, Michael Erman in Maplewood, N.J. and Lisa Baertlein in Los Angeles; Editing by Shounak Dasgupta, Anil D’Silva, Jan Harvey and Nick Macfie)

Racing the virus: Why tweaking the vaccines won’t be simple

By Julie Steenhuysen and Michael Erman

CHICAGO (Reuters) – After developing and rolling out COVID-19 vaccines at record speed, drugmakers are already facing variants of the rapidly-evolving coronavirus that may render them ineffective, a challenge that will require months of research and a massive financial investment, according to disease experts.

Executives from Moderna Inc and Pfizer Inc and partner BioNTech SE are considering new versions of their vaccines to respond to the most concerning variants identified so far. That is just one piece of the work needed to stay ahead of the virus, nearly a dozen experts told Reuters.

A global surveillance network to assess emerging variants must be built. Scientists need to establish what level of antibodies will be required to protect people from COVID-19 and determine when vaccines need to be altered. And regulators must convey what is needed to demonstrate updated vaccines are still safe and effective.

“At this point, there is no evidence that these variants have changed the equation in terms of protection from the vaccine,” said Dr. Michael Osterholm, an infectious disease expert at the University of Minnesota. “But we have to be prepared for that.”

Johnson & Johnson told Reuters the concerning variant first identified in South African has got its attention and will tweak its vaccine accordingly if needed. Pfizer said it could produce a new vaccine relatively quickly, but a top vaccine executive said manufacturing it presents additional challenges.

The urgency of this effort is clear.

Moderna on Monday said lab studies showed antibodies made in response to its vaccine were six times less effective at neutralizing a lab-created version of a South African variant than prior versions of the virus.

A study released on Wednesday ahead of peer review found the South African variant reduced neutralizing antibodies 8.6-fold for the Moderna vaccine and by 6.5-fold for the Pfizer/BioNTech shot, although a separate Pfizer-backed study released on Wednesday suggests its vaccine may be more hardy. Moderna said this week it is starting work on a potential booster shot.

COULD TAKE MONTHS

Just how far protection can drop before a COVID-19 vaccine needs to be altered is not yet known. With influenza, an eightfold drop in vaccine-induced antibody protection means time to update. That does not necessarily apply to this coronavirus.

“The problem is we don’t know what the cut point is for coronavirus,” said Dr. John Mascola, director of the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID), whose scientists helped develop Moderna’s vaccine.

Mascola said both studies testing the Moderna vaccine against the South African variant are roughly in the “same ballpark.” It could be that antibody protection is high enough from the vaccine that it will still be effective, he said.

NIAID scientists are analyzing data from Moderna’s late-stage trial to see what level of neutralizing antibodies is required for protection. They are comparing individuals who were vaccinated but got sick anyway to vaccinated people who remained healthy.

It could take two months to complete this work, Mascola said. They hope to produce a benchmark for the minimum level of vaccine-induced antibodies needed to protect against COVID-19.

A global surveillance network is also needed to identify troubling new variants as they emerge, similar to one used to track fast-mutating flu viruses. That could cost tens to hundreds of millions of dollars in the United States alone.

Richard Webby, a flu surveillance expert from St. Jude Children’s Research Hospital, said the United States could probably build a system to identify variants fairly quickly. Developing the capability to determine whether they evade current vaccines will take more time.

The United States is currently conducting genetic sequencing to look for changes in the virus in just 0.3% of positive coronavirus tests. That pales compared with 10% in the UK, which was first to discover a major mutation in the virus that increases transmission by at least 50%. Experts said countries should sequence at least 5% of positive cases to detect significant changes in the virus.

Companies are waiting for the U.S. Food and Drug Administration to relay what testing will be needed for altered vaccines, said Phil Dormitzer, one of Pfizer’s top viral vaccine scientists. With influenza vaccines, companies can make changes without new trials. “But that’s after doing it for 50 years,” he said.

Peter Marks, who oversees the FDA’s vaccine approval process, has said small trials testing updated vaccines in around 400 participants may be needed at first. Even that could add months to the process.

Norman Baylor, chief executive of Biologics Consulting and a former FDA vaccines official, said the agency will lay out the regulatory road. But public health agencies like the U.S. Centers for Disease Control and Prevention and the World Health Organization would decide when vaccines should be updated, as with flu.

Altering Pfizer’s vaccine would require “a very minor change,” Dormitzer said.

Like Moderna’s, it uses messenger RNA (mRNA) technology, which relies on synthetic genes that can be generated and manufactured in weeks.

He estimates the company could make a prototype version in a week or so, and take another two months to scale up and update their lab tests.

J&J, which is expected to release late-stage trial data on its vaccine within days, has laid the groundwork to address troubling virus changes, Chief Scientific Officer Paul Stoffels told Reuters. Its trial included sites in South Africa, which should give the company insight on that variant.

If a change is necessary, Stoffels said J&J likely would add a second strain into its existing vaccine.

“We are looking at this with a lot of attention,” he said.

(Reporting by Julie Steenhuysen in Chicago and Michael Erman in New York; Editing by Caroline Humer and Bill Berkrot)

Explainer-When and how will COVID-19 vaccines become available?

By Julie Steenhuysen and Carl O’Donnell

NEW YORK (Reuters) – Pfizer Inc with partner BioNTech SE and Moderna Inc have released trial data showing their COVID-19 vaccines to be about 95% effective at preventing the illness, while AstraZeneca Plc this week said its vaccine could be up to 90% effective.

If regulators approve any of the vaccines in coming weeks, the companies have said distribution could begin almost immediately with governments around the world to decide who gets them and in what order. The following is an outline of the process:

WHEN WILL COMPANIES ROLL OUT A VACCINE?

Pfizer, Moderna and AstraZeneca have already started manufacturing their vaccines. This year, Pfizer said it will have enough to inoculate 25 million people, Moderna will have enough for 10 million people and AstraZeneca will have enough for more than 100 million people.

The U.S. Department of Defense and the Centers for Disease Control and Prevention (CDC) will manage distribution in the United States, likely starting in mid-December with an initial release of 6.4 million doses nationwide.

UK health authorities plan to roll out an approved vaccine as quickly as possible, also expected in December.

In the European Union, it is up to each country in the 27-member bloc to start distributing vaccines to their populations.

WHO WOULD GET AN APPROVED VACCINE AND WHEN IN THE UNITED STATES?

Upon authorization from the U.S. Food and Drug Administration, the CDC has said first in line for vaccinations would be about 21 million healthcare workers and 3 million residents in long-term care facilities.

Essential workers, a group of 87 million people who do crucial work in jobs that cannot be done from home, are the likely next group. This includes firefighters, police, school employees, transportation workers, food and agriculture workers and food service employees.

Around 100 million adults with high-risk medical conditions and 53 million adults over the age of 65, also considered at higher risk of severe disease, are the next priority.

U.S. public health officials said vaccines will be generally available to most Americans in pharmacies, clinics and doctors offices starting in April so that anyone who wants a shot can have one by the end of June.

It is unclear when a vaccine will be available for children. Pfizer and BioNTech have started testing their vaccine in volunteers as young as 12.

WHEN WILL A VACCINE BE AVAILABLE IN OTHER COUNTRIES?

The European Union, the United Kingdom, Japan, Canada and Australia are all running rapid vaccine regulatory processes.

Many of AstraZeneca’s doses this year are expected to go to the United Kingdom, where health officials have said that if approved they could begin vaccinating people in December. At the top of their list is people living and working in care homes.

In Europe, the E.U. drugs regulator has said it could rule on the safety of a COVID-19 vaccine in December.

Most countries have said the first vaccines will go to the elderly and vulnerable and frontline workers like doctors.

Countries say they are buying vaccines via the European Commission’s joint procurement scheme, which has deals for six different vaccines and nearly 2 billion doses.

Delivery timelines vary and most countries are still drawing up plans for distributing and administering shots.

Italy expects to receive the first deliveries of the Pfizer-BioNTech shot and AstraZeneca’s shot early next year. Spain plans to give vaccines in January.

In Bulgaria, the country’s chief health inspector expects the first shipments in March-April. Hungary’s foreign minister said doses will land in the spring at the earliest.

Germany, home to BioNTech, expects to roll out shots in early 2021 with mass vaccination centers in exhibition halls, airport terminals and concert venues. It will also use mobile teams for care homes. Front-line healthcare workers and people at risk for serious COVID-19 are expected to get inoculated first.

WHEN WILL DEVELOPING COUNTRIES HAVE ACCESS TO VACCINES?

COVAX, a program led by the World Health Organization and the GAVI vaccine group to pool funds from wealthier countries and nonprofits to buy and distribute vaccines to dozens of poorer countries, has raised $2 billion.

Its first goal is to vaccinate 3% of the people in these countries with a final goal of reaching 20%. It has signed a provisional agreement to buy AstraZeneca’s vaccine, which does not require storage in specialized ultra cold equipment like the Pfizer vaccine.

It is expected but not certain that less wealthy countries in Africa and South East Asia, such as India, will receive vaccines at low or no cost under this program in 2021. Other countries such as those in Latin America may buy vaccines through COVAX. Several are also striking supply deals with drugmakers.

HOW MUCH WILL IT COST?

Vaccine makers and governments have negotiated varying prices, not all of which are public. Governments have paid from a few dollars per AstraZeneca shot to up to $50 for the two-dose Pfizer regimen. Many countries have said they will cover the cost of inoculating their residents.

(Reporting by Carl O’Donnell and Julie Steenhuysen; Additional reporting by Michael Erman in New York, Caroline Copley in Berlin, Francesco Gaurascio in Brussels, Josephine Mason in London, Krisztina Than in Budapest and Tsvetelia Tsolova in Sofia; Editing by Caroline Humer and Bill Berkrot)

Pfizer is first to apply for U.S. emergency use for COVID-19 vaccine

By Vishwadha Chander

(Reuters) – Pfizer Inc. said it will apply to U.S. health regulators on Friday for emergency use authorization (EUA) of its COVID-19 vaccine, the first such application in a major step toward providing protection against the new coronavirus.

The application to the U.S. Food and Drug Administration (FDA) comes just days after Pfizer and German partner BioNTech SE reported final trial results that showed the vaccine was 95% effective in preventing COVID-19 with no major safety concerns.

Pfizer’s shares rose 1.6% and BioNTech climbed 6% on the news that a vaccine could soon be available, raising hopes for the end of a pandemic that has claimed more than a quarter of a million lives in the United States and over 1.3 million worldwide.

The application also includes safety data on about 100 children 12-15 years of age. The company said 45% of U.S. trial participants are 56-85 years old.

If the data is solid, “we literally could be weeks away from the authorization of a 95% effective vaccine,” U.S. Health Secretary Alex Azar said on CBS’ “This Morning”.

The companies expect the FDA to grant the EUA by mid-December and said they will begin shipping doses almost immediately. Pfizer has said it expects to have 50 million vaccine doses ready this year, enough to protect 25 million people.

An FDA advisory committee tentatively plans to meet Dec. 8-10 to discuss the vaccine, a source familiar with the situation told Reuters, though the dates could change.

The final trial data showed the vaccine provided a similar level of protection across different ages and ethnicities – an encouraging result as the disease disproportionately hurts the elderly and minorities.

Of the 170 volunteers who contracted COVID-19 in Pfizer’s trial involving over 43,000 people, 162 had received only a placebo, meaning the vaccine was 95% effective, far higher than originally expected. U.S. FDA had set minimum bar for efficacy of 50%.

Pfizer said nearly 42% of global participants and 30% of U.S. participants in the Phase 3 study have racially and ethnically diverse backgrounds.

“Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine,” Pfizer Chief Executive Officer Albert Bourla said in a statement.

Moderna Inc. is expected to be the next company to seek a U.S. emergency use nod for a COVID-19 vaccine. An initial analysis of data from its late-stage trial showed the vaccine was 94.5% effective. Final results and safety data are expected in the coming days or weeks.

Both the Pfizer/BioNTech and Moderna vaccines work using a new technology to trigger an immune response known as synthetic messenger RNA that can be produced at scale much more quickly than traditional vaccines.

Of dozens of drugmakers and research institutions racing to develop COVID-19 vaccines, the next late-stage data is expected to come from AstraZeneca Plc, which is working with the University of Oxford, in November or December.

Johnson & Johnson said it expects to have data needed to seek U.S. authorization for its experimental vaccine by February.

(Reporting by Vishwadha Chander in Bengaluru, additional reporting by Ankur Banerjee in Bengaluru and Doina Chiacu in Washington; Editing by Bill Berkrot, Shinjini Ganguli and Chizu Nomiyama)

Pfizer ends vaccine trial with 95% success rate, paving way for a shot this year

By Michael Erman and Ludwig Burger

(Reuters) – Pfizer Inc and BioNTech could secure emergency U.S. and European authorization for their COVID-19 vaccine next month after final trial results showed it had a 95% success rate and no serious side effects, the drugmakers said on Wednesday.

The efficacy of the shot was found to be consistent across different ages and ethnicities – a promising sign given the disease has disproportionately affected the elderly and certain groups including Black people.

The U.S. Food and Drug Administration could grant emergency-use approval towards the end of the first half of December or early in the second half, BioNTech Chief Executive Ugur Sahin told Reuters TV. Conditional approval in the European Union could be secured in the second half of December, he added.

“If all goes well I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively,” he said.

The success rate of the vaccine developed by U.S. firm Pfizer and Germany’s BioNTech is the highest of any candidate in late-stage clinical trials so far, and experts said it was a significant achievement in the race to end the pandemic.

Pfizer said 170 volunteers in its trial involving over 43,000 people contracted COVID-19 but 162 of them had only been given a placebo, meaning the vaccine was 95% effective. Of the 10 people who had severe COVID-19, one had received the vaccine.

“A first in the history of mankind: less than a year from the sequence of the virus to the large-scale clinical trial of a vaccine, moreover based on a whole new technique,” said Enrico Bucci, a biologist at Temple University in Philadelphia. “Today is a special day.”

BioNTech’s Sahin said the U.S. emergency authorization would be applied for on Friday.

The FDA committee tentatively plans to meet on Dec. 8-10, a source familiar with the situation said, though the dates could still change. The FDA did not respond to requests for comment.

COVID-19 RUNS RAMPANT

The final trial analysis comes a week after initial results showed the vaccine was more than 90% effective. Moderna Inc <MRNA.O> released preliminary data for its vaccine on Monday, showing 94.5% effectiveness.

The better-than-expected results from the two vaccines, both developed with new messenger RNA (mRNA) technology, have raised hopes for an end to a pandemic that has killed more than 1.3 million people and wreaked havoc upon economies and daily life.

The Pfizer-BioNTech shot was found to have 94% efficacy in people over 65 years, which experts said was crucial at a time when COVID-19 is running rampant around the world with record numbers of new cases and hospitalizations.

“This is the evidence we needed to ensure that the most vulnerable people are protected,” said Andrew Hill, senior visiting research fellow at the University of Liverpool’s department of pharmacology.

Global shares rose as the trial results countered concerns around the stubbornly high global infection rate. Pfizer shares were up 1.6% while BioNTech jumped 3.8% in the United States. By contrast, Moderna dropped 4.2%.

Investors have treated vaccine development as a race between companies, although there is likely to be global demand for as much vaccine as can be produced for the foreseeable future.

DISTRIBUTING SHOTS

Pfizer says it expects to make as many as 50 million vaccine doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.

While some groups such as healthcare workers will be prioritized in the United States and Britain for vaccinations this year, it will be months before large-scale rollouts begin in either country.

Pfizer also has agreements with the European Union, Germany and Japan where distribution could begin next year.

Mike Ryan, the World Health Organization’s top emergency expert, said it would be at least 4-6 months before significant levels of vaccination were taking place around the world.

Distribution of a Pfizer-BioNTech shot is complicated by the need to store it at ultra-cold temperatures of -70 degrees Celsius. It can, however, be kept in a normal fridge for up to five days, or up to 15 days in a thermal shipping box.

Moderna’s vaccine can be stored for up to six months at -20C though it is expected to be stable for 30 days at normal fridge temperatures of 2 to 8 degrees Celsius (36°-46°F).

FATIGUE AND HEADACHES

Pfizer said its two-dose vaccine, called BNT162b2, was well-tolerated and that side effects were mostly mild to moderate, and cleared up quickly.

It said the only severe adverse events experienced by volunteers were fatigue and headaches. Out of 8,000 participants, 2% had headaches after the second dose while 3.8% experienced fatigue. Older adults tended to report fewer and milder adverse events.

“These are extraordinary results, and the safety data look good,” said David Spiegelhalter, a professor and expert in risk and evidence communication at the University of Cambridge.

“It would be interesting to see what adverse reactions were reported by the group getting the placebo, since that gives an idea of how much of the adverse effects are due to the vaccination process, and how much is due to the vaccine itself.”

Of the dozens of drugmakers and research groups racing to develop vaccines against COVID-19, the next data release will likely be from AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson says it is on track to deliver data this year.

Authorization of vaccines for children will take longer. Only Pfizer has started vaccinating volunteers under the age of 18 in trials, giving shots to children as young as 12. Moderna and Johnson & Johnson have said they hope to start testing the vaccine in younger patients soon.

(Reporting by Michael Erman in Maplewood, N.J.; Additional reporting by Ankur Banerjee in Bengaluru, Caroline Humer in New York, Dan Levine in San Francisco, Elizabeth Howcroft, Kate Kelland and Josephine Mason in London, Emilio Parodi in Milan and Stephanie Nebehay in Geneva; Writing by David Clarke; Editing by Pravin Char)

Pfizer to start pilot delivery program for its COVID-19 vaccine in four U.S. states

(Reuters) – Pfizer Inc. has launched a pilot delivery program for its experimental COVID-19 vaccine in four U.S. states, as the U.S. drugmaker seeks to address distribution challenges facing its ultra-cold storage requirements.

Pfizer’s vaccine, which was shown to be more than 90% effective in preventing COVID-19 based on initial data, must be shipped and stored at -70 degrees Celsius (minus 94°F), significantly below the standard for vaccines of 2-8 degrees Celsius (36-46°F).

“We are hopeful that results from this vaccine delivery pilot will serve as the model for other U.S. states and international governments, as they prepare to implement effective COVID-19 vaccine programs,” Pfizer said in a statement on Monday.

It picked Rhode Island, Texas, New Mexico, and Tennessee for the program after taking into account their differences in overall size, diversity of populations, immunization infrastructure, and need to reach individuals in varied urban and rural settings.

The four states will not receive vaccine doses earlier than other states by virtue of the pilot, nor will they receive any differential consideration, Pfizer said.

The company expects to have enough safety data on the vaccine from the ongoing large scale late-stage trials by the third week of November before proceeding to apply for emergency use authorization (EUA).

Pfizer and its partner BioNTech SE have a $1.95 billion deal to supply 100 million doses of the vaccine to the U.S. government, which has an option to acquire up to an additional 500 million doses.

Earlier on Monday, rival Moderna Inc. said its experimental vaccine was 94.5% effective in preventing COVID-19 based on interim data from a late-stage trial, boosting hopes that vaccines against the disease may be ready for use soon.

Both the Pfizer and Moderna vaccines use a new technology called synthetic messenger RNA to activate the immune system against the virus.

(Reporting by Shubham Kalia in Bengaluru; Editing by Anil D’Silva and Richard Pullin)

Fauci not advising Biden, sees no reason to quit Trump now: Reuters interview

By Julie Steenhuysen

CHICAGO (Reuters) – Dr. Anthony Fauci, the top U.S. infectious disease expert, said he has had no contact with President-elect Joe Biden’s coronavirus transition team and sees no reason to quit to join that effort when there is so much to do now to fight the surging pandemic.

“I stay in my lane. I’m not a politician. I do public health things,” he said in an interview on Thursday ahead of next week’s Reuters Total Health conference.

Since January, Fauci has served on President Donald Trump’s White House Coronavirus Task Force, a position that has frequently put him at odds with the president, who has sought to downplay the pandemic and focused instead on opening the economy.

“There’s absolutely no reason and no sense at all for me to stop doing something in the middle of a pandemic that is playing a major role in helping us get out of the pandemic,” Fauci said.

His advice for the president-elect, he said, is “exactly the same” as what he is recommending now – social distancing, avoiding crowds, wearing masks, washing hands. “Public health principles don’t change from one month to another or from one administration to another.”

Fauci has served six administrations and came to prominence fighting the AIDS epidemic in the 1980s under President Ronald Reagan.

His “day job” is developing vaccines and therapeutics as director of the National Institute of Allergy and Infectious Diseases, work that is starting to bear fruit.

On Monday, Pfizer Inc and German partner BioNTech SE announced that their experimental coronavirus vaccine was more than 90% effective – significantly higher than most experts had anticipated.

Moderna Inc, a company developing a similar vaccine with support from the White House’s Operation Warp Speed program, is expected to report results from their late-stage vaccine trial in the next week or so.

Both vaccines use messenger RNA (mRNA) technology, an entirely new rapid vaccine platform that uses synthetic genes to trigger an immune response. Older methods typically use some form of inactivated or killed virus particles.

“It was a home run for the Pfizer product, more than 90% – close to 95% – effective. I have every reason to believe that the Moderna product is going to be similar,” Fauci said.

“It’s an almost identical platform to the Pfizer vaccine, so I would not be surprised at all if it was highly effective,” Fauci added.

The next big question about mRNA technology is safety. Fauci took as a good sign the fact that neither the Pfizer trial, which has enrolled more than 43,000 people so far, nor the Moderna trial, which involves 30,000, had to pause to investigate safety issues.

“That’s really good news,” he said. People in both trials will be followed for two years to make sure there are no long-term side effects. Barring that, “I think that the mRNA platform is here to stay,” he predicted.

In spite of the high bar set by the Pfizer vaccine so far, Fauci said he believes there is still “plenty of room for multiple vaccines, even though there may be a modest degree of difference in total efficacy.”

(Reporting by Julie Steenhuysen, Editing by Peter Henderson and Bill Berkrot)

Explainer – Shot in the dark: Early COVID-19 vaccine efficacy explained

By John Miller

ZURICH (Reuters) – This week has seen a flurry of good news from COVID-19 vaccine developers, with Pfizer Inc. and BioNTech SE trumpeting early data indicating their mRNA candidate is more than 90% effective.

A Russian project came out a day later, touting 92% efficacy for the Sputnik V candidate, named after the Soviet-era satellite, based on a smaller data set.

HOW DO MANUFACTURERS ARRIVE AT EFFICACY NUMBERS?

In Pfizer’s case, it waited until 94 volunteers in its late-stage clinical trial of more than 43,500 people – half got the vaccine, the other half got a placebo – tested positive after developing symptoms.

For 90%-plus efficacy, no more than eight people among those who tested positive had received the vaccine, with the rest having received the placebo.

“Roughly speaking, it’s probably around eight to 86 cases in the treated and placebo groups,” David Spiegelhalter, a Cambridge professor of risk and an expert in statistics, told Reuters.

“You don’t need a lot of fancy statistical analysis to show that this is deeply impressive. It just hits you between the eyes.”

In Russia, Sputnik V-developer Gamaleya Institute reached its preliminary 92% efficacy figure based on 20 illnesses in 16,000 volunteers as its late-stage trial progresses. It aims to reach 40,000 people.

Of the 16,000 people, about quarter got the placebo.

“It suggests that there is some effect, but it’s insufficient to estimate the magnitude of it,” Spiegelhalter said.

HOW MANY PEOPLE MUST GET SICK IN BIG VACCINE TRIALS?

Some experts say that, ideally, 150 to 160 people in a trial of tens of thousands of participants must get sick before making a reliable assessment of a vaccine’s efficacy. That’s a bit of a rule of thumb, though, open to interpretation.

“There is no such regulatory standard requiring X number of events for making a reliable decision,” the government-funded Swiss Clinical Trial Organization said. “The amount of (infections) has to be seen in relation to the disease and its risk profile. It’s rather a case-by-case evaluation.”

Typically, regulators strive to have at least 95% certainty that the trial read-out is not the result of random variations with nothing to do with the tested compound.

For trial sponsors there is safety in numbers as a large enough trial can ensure that 95% reliability hurdle is cleared. But the larger the underlying clinical benefit, the fewer trial participants needed to create that clarity.

In Pfizer and BioNTech’s trial, they planned a final analysis when 164 people had become sick, with multiple, pre-planned interim analyses along the way. They skipped an analysis at 32 patients, and once they were ready to release a look at the 62-person mark, 94 had come down sick.

Details from the Russian trial are unclear, without access to its protocol.

HOW DO THESE RESULTS STACK UP TO OTHER DRUGS, OR VACCINES FOR OTHER ILLNESSES?

In normal drug trials, for diseases like terminal cancer, benefits of new medicines may be less apparent, with survival benefits of just a few months sometimes revolutionary for patients at death’s door.

For vaccines, however, marginal protection is inadequate, and the World Health Organization ideally wants to see at least 70% efficacy in trials, while the U.S. Food and Drug Administration wants at least 50%.

The 90% efficacy reported in the Pfizer and Russian trials beats those, and appears to exceed that of typical flu vaccines, which the U.S. Centers for Disease Control and Prevention (CDC) estimate reduce the risk of sickness by 40%-60%.

For other shots, the CDC estimates the efficacy of a two-shot measles vaccine at 97%, and a two-dose chicken pox vaccine at 90%. Two doses of polio vaccine are 90% effective, rising to nearly 100% with a third.

CAN WE EXPECT EFFICACY RATES TO HOLD UP AS TRIALS ADVANCE?

Pfizer acknowledged on Monday that its final vaccine efficacy percentage may vary. Still, Spiegelhalter said the study’s design seems likely to generally hold up, based on the 94 sick participants.

“In this case, the effect is so huge, even if there is a little bit of fallback – if the effects become slightly smaller over time – that is very unlikely to be significant.”

WHAT ABOUT REAL-WORLD EFFICACY, SHOULD THE VACCINES BE APPROVED?

The interim data is promising, since it appears to demonstrate that a vaccine can be effective in preventing COVID-19.

The jump to mass vaccinations, however, presents new hurdles, in particular for an mRNA vaccine like Pfizer and BioNTech’s that must be stored and shipped at minus 70 degrees Celsius (-94°F).

Moreover, the Pfizer-BioNTech vaccine requires two doses, ideally 21 days apart. If people do not stick to the timetable, it may affect the vaccine’s efficacy.

Protection against the mumps, for instance, drops from nearly 90% to 78%, if people don’t get a follow-up shot.

Swiss epidemiologist Marcel Tanner, president of Switzerland’s Academies of Arts and Sciences and one of the government’s top COVID-19 science advisers, expects possible variations in efficacy among older people, whose immune systems wane with time, or those with immune disorders.

“Efficacy says, ‘Does it work?’ Effectiveness says, ‘Can it be applied? Can you carry the efficacy to the people?'” Tanner said. “But no question: 90% efficacy, at that stage, is a pretty good result.”

(Reporting by John Miller in Zurich, Kate Kelland in London, Ankur Banerjee in Bengaluru, Julie Steenhuysen in Chicago and Polina Ivanova in Moscow; Editing by Josephine Mason and Nick Macfie)

Pfizer CEO made $5.6 million stock sale on same day as COVID-19 vaccine update: filing

(Reuters) – Pfizer Inc Chief Executive Officer Albert Bourla sold $5.56 million worth of company shares on Monday, the day the drugmaker said its COVID-19 vaccine was 90% effective based on interim trial results, a regulatory filing showed.

Bourla authorized the sale of the shares on Aug. 19, provided the stock was at least at a certain price, as part of a predetermined plan, the company said.

Bourla sold 132,508 shares at $41.94 per share, according to a Securities and Exchange Commission filing late Tuesday.

“The sale of these shares is part of Dr. Bourla’s personal financial planning and a pre-established (10b5-1) plan, which allows, under SEC rules, major shareholders and insiders of exchange-listed corporations to trade a predetermined number of shares at a predetermined time,” Pfizer said.

Pfizer said on Monday its experimental COVID-19 vaccine was more than 90% effective based on initial trial results, sending its shares higher along with the broader markets.

The company’s shares rose as much as 15% to trade at session high of $41.99 on Monday, before closing up 7.7%. They were trading at 38.75 on Wednesday.

Pfizer and German partner BioNTech SE have said no serious safety concerns were found so far and expect to seek U.S. emergency use authorization this month, raising the chance of a regulatory decision as soon as December.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shinjini Ganguli and Shounak Dasgupta)

Q&A: Where are we in the COVID-19 vaccine race?

(Reuters) – Drugmakers and research centers around the world are working on COVID-19 vaccines, with large global trials of several of the candidates involving tens of thousands of participants well underway.

The following is what we know about the race to deliver vaccines to help end the coronavirus pandemic that has claimed over 1.26 million lives worldwide:

Who is furthest along?

U.S. drugmaker Pfizer Inc and German partner BioNTech SE were the first to release data showing on Monday that their vaccine worked in a large, late-stage clinical trial.

Russia’s sovereign wealth fund published interim late-stage trial results for its Sputnik V vaccine on Wednesday showing the shot is 92% effective at protecting people from COVID-19.

The next data releases will likely be from U.S. biotech firm Moderna Inc, possibly in November, and from Britain-based AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson says it is on track to deliver data this year.

What happens in these trials?

The companies are testing their vaccines against a placebo – typically saline solution – in healthy volunteers to see if the rate of COVID-19 infection among those who got the vaccine is significantly lower than in those who received the dummy shot.

Why is Pfizer ahead with its data?

The trials rely on subjects becoming naturally infected with the coronavirus, so how long it takes to generate results largely depends on how pervasive the virus is where trials are being conducted. Each drugmaker has targeted a specific number of infections to trigger a first analysis of their data.

Pfizer said its interim analysis was conducted after 94 participants in the trial developed COVID-19 while Russia’s examination was conducted after 20 participants in the trial developed the disease.

AstraZeneca said last week a slowdown in infections during the summer is delaying data analysis for its UK trial.

COVID-19 cases, however, soared in October and early November, setting daily records in the United States and Europe.

How well are the vaccines supposed to work?

The World Health Organization has recommended a minimum standard for effectiveness of at least 50%. The United States and some other regulators are following that guideline – which means there must be at least twice as many infections among volunteers who received a placebo as among those in the vaccine group. The European Medicines Agency has said it may accept a lower efficacy level.

Pfizer and Russia both said their vaccines are more than 90% effective against COVID-19.

When will regulators rule on safety and efficacy?

Regulators review vaccines after companies submit applications seeking either emergency use authorization (EUA) or formal approval.

The earliest the U.S. Food and Drug Administration could make a decision is in December because Pfizer/BioNTech and Moderna do not expect to have enough safety data until the second half of November. The FDA has asked companies to watch trial participants for side effects for two months after receiving a final vaccine dose.

Regulators for Europe, the United Kingdom and Canada are considering data on a rolling basis, as it becomes available. They expect to conduct expedited reviews as well. It is not clear when companies will submit efficacy data to these agencies or when the agencies would make a decision.

Could these be the first widely available coronavirus vaccines?

Yes, although China is on a similar timeline. The country launched an emergency use program in July aimed at essential workers and others at high risk of infection that has vaccinated hundreds of thousands of people.

At least four vaccines are far along including those from China National Biotec Group (CNBG), CanSino Biologics and Sinovac. Sinovac and CNBG have said to expect early trial data as soon as November.

Russia has also given the Sputnik V vaccine developed by the Gamaleya Institute to 10,000 members of the general population considered at high risk of contracting the virus.

In late October, the director of the Gamaleya Institute, Alexander Gintsburg, said 20,000 volunteers had received the first shot so far and 9,000 the second.

(Reporting by Carl O’Donnell in New York; Additional reporting by Julie Steenhuysen in Chicago, Michael Erman in New York, Ludwig Burger in Frankfurt, Alistair Smout in London and Polina Ivanova in Moscow; Editing by Caroline Humer, Bill Berkrot, Edwina Gibbs, David Clarke and Josephine Mason)