Tag Archives: Pfizer Inc

U.S. to buy 10 million courses of Pfizer’s COVID-19 pill for $5.3 billion

By Manas Mishra

(Reuters) – Pfizer Inc said on Thursday the U.S. government would pay $5.29 billion for 10 million courses of its experimental COVID-19 antiviral drug, as the country rushes to secure promising oral treatments for the disease.

The deal is for around twice as many treatment courses as Merck & Co Inc has agreed to supply the United States under its contract. The price for the Pfizer pill is nearly 25%lower at roughly $530 per course, compared with about $700 for Merck’s.

Pfizer applied for emergency authorization of the drug, branded as Paxlovid, this week after reporting data showing that it was 89% effective at preventing hospitalization or death in at-risk people. The trial’s results suggest that Paxlovid surpasses Merck’s molnupiravir which was shown last month to halve the risk of dying or being hospitalized for COVID-19 patients at high risk of serious illness.

“While this pill still requires a full review by the Food and Drug Administration, I have taken immediate steps to secure enough supply for the American people,” President Joe Biden said in a statement. He added that his administration was making preparations to ensure the treatment is easily accessible and free.

Pfizer said it would begin deliveries of the treatment as soon as this year if it is authorized by the U.S. FDA.

Shares of Pfizer were up 0.65% at $51.20 on Thursday afternoon, while shares of Merck were nearly flat at $82.63.

Getting vaccinated should still be the priority for Americans but having pills that can keep people out of the hospital “could be a lifesaver,” said U.S. Secretary of Health and Human Services Xavier Becerra.

Pfizer has said it expects to manufacture 180,000 treatment courses by the end of next month and at least 50 million courses by the end of 2022.

Countries have scrambled to secure doses of the Pfizer and Merck oral drugs, based on promising data reported by both companies.

The U.S. government has so far secured 3.1 million courses of Merck’s COVID-19 pill for $2.2 billion, with the right to buy 2 million more courses in the future.

Drugs in the same class as Merck’s pill have been linked to birth defects in animal studies. Merck has said similar studies of its drug – for longer and at higher doses than used in humans – show that it does not cause birth defects or cancer.

(Reporting by Manas Mishra in Bengaluru, Additional reporting by Michael Erman in New Jersey; Editing by Ramakrishnan M. and Matthew Lewis)

What you need to know about the coronavirus right now

(Reuters) – Here’s what you need to know about the coronavirus right now:

Lawsuit consolidation set to give Biden administration a chance to revive COVID vaccine mandate

Lawsuits filed around the United States challenging the Biden administration’s workplace COVID-19 vaccine rule are expected to be consolidated in a single federal appeals court on Tuesday, giving the government a chance to revive a rule that was blocked last week.

More than a dozen lawsuits have been filed challenging the rule, which requires employers with at least 100 workers to mandate COVID-19 vaccination or weekly testing combined with wearing a face covering at work.

Pfizer to allow generic versions of its COVID-19 pill in 95 countries

Pfizer Inc said on Tuesday it will allow generic manufacturers to supply its experimental antiviral COVID-19 pill to 95 low- and middle-income countries through a licensing agreement with international public health group Medicines Patent Pool (MPP).

The voluntary licensing agreement between Pfizer and the MPPwill allow the United Nations-backed group to grant sub-licenses to qualified generic drug manufacturers to make their own versions of PF-07321332.

Pfizer will sell the pills it manufactures under the brand name Paxlovid.

Delta dominates, scientists watch for worrisome offspring

The Delta variant of the SARS-CoV-2 virus now accounts for nearly all coronavirus infections globally and virus experts are closely watching its evolution, looking for signs of mutation.

According to the WHO, Delta makes up 99.5% of all genomic sequences reported to public databases and has “outcompeted” other variants in most countries.

A key exception is South America, where Delta has spread more gradually, and other variants previously seen as possible global threats – notably Gamma, Lambda and Mu – still contribute to a significant proportion of reported cases.

Japan plans to ease quarantine rules – report

Japan intends to ease quarantine rules by the end of November for people inoculated with Johnson & Johnson’s COVID-19 vaccine, the Nikkei daily reported on Tuesday.

Last week the country took a first step in its planned phased re-opening of borders, which centers on business travelers.

Germany could make COVID test or vaccine mandatory for public transport

Want to take the bus or train in Germany? You may soon have to provide a negative COVID-19 test, or proof of vaccination or recent recovery, as the country becomes the latest in Europe to consider drastic steps to tackle a new surge in cases in the region.

The center-left Social Democrats, Greens and pro-business FDP said on Monday they would add harsher measures to their draft law under parliamentary consideration to deal with the outbreak.

India’s Dr. Reddy’s open to making Pfizer pill

Dr. Reddy’s Laboratories, one of a handful of Indian drug companies licensed to make a new COVID-19 pill developed by Merck, said on Monday it was open to making a similar pill from Pfizer thought to be even more effective.

The new drugs, which unlike vaccines can be used to treat patients once they contract coronavirus infections, are expected to have a huge market.

Merck has licensed manufacturers in developing countries to ensure swift global supply, and companies are hopeful that Pfizer will do the same.

(Compiled by Karishma Singh and Ed Osmond; Editing by Jan Harvey)

Pfizer study to vaccinate whole Brazilian town against COVID-19

BRASILIA (Reuters) -Pfizer Inc will study the effectiveness of its vaccine against COVID-19 by inoculating the whole population over the age of 12 in a town in southern Brazil, the company said on Wednesday.

The study will be conducted in Toledo, population 143,000, in the west of Parana state, together with Brazil’s National Vaccination Program, local health authorities, a hospital and a federal university.

Pfizer said the purpose was to study transmission of the coronavirus in a “real-life scenario” after the population has been vaccinated.

“The initiative is the first and only of its kind to be undertaken in collaboration with the pharmaceutical company in a developing country,” Pfizer said.

A similar study was conducted by the Butantan Institute, one of Brazil’s leading biomedical research centers, in the smaller town of Serrana, in Sao Paulo state, to test the CoronaVac shot developed by China’s Sinovac Biotech Ltd.

In May, Butantan said mass vaccination had reduced COVID-19 death by 95% in the town with a population of 45,644 people. The institute is considering extending the study for a third dose.

“Here we believe in science and we lament the almost 600,000 deaths from COVID-19 in Brazil,” Toledo Mayor Beto Lunitti said at a news conference announcing the Pfizer study.

Regis Goulart, a researcher at Toledo’s Moinhos de Vento Hospital, said its aim was to validate the real-world efficacy and safety of the vaccine seen in clinical trials.

The observational study will also be an opportunity to do long-term monitoring for up to one year of participants and to answer lingering questions such as the duration of vaccine protection against COVID-19 and new variants, Goulart said.

(Reporting by Anthony Boadle; Editing by Jason Neely and Mark Porter)

COVID-19 vaccine makers tell Congress U.S. supply will surge soon

By Michael Erman and Manojna Maddipatla

NEW YORK (Reuters) – COVID-19 vaccine makers told Congress on Tuesday that U.S. supplies should surge in the coming weeks due to manufacturing expansions and new vaccine authorizations.

Executives from Pfizer Inc, Moderna Inc and Johnson & Johnson – speaking at a hearing at the U.S. House of Representatives – said they would be able to supply enough vaccine to fully inoculate 130 million people in the United States by the end of March.

The drugmakers also reaffirmed their commitments to supply more than enough doses necessary to vaccinate all Americans by the end of July.

Pfizer Chief Business Officer John Young said it was plausible that there could be a surplus of vaccine in the United States sometime in the second quarter of this year.

“We certainly hope that we’re going to be in a position where every eligible adult will be able to receive vaccinations,” Young said.

Around 44.5 million people in the United States had received at least one dose of two-shot vaccines developed by Pfizer and BioNTech or Moderna, as of Tuesday morning.

Johnson & Johnson’s single-dose vaccine will be considered by an outside advisory committee to the U.S. Food and Drug Administration later this week, and emergency use authorization could come shortly afterward.

Richard Nettles, Vice President of Medical Affairs at J&J’s Janssen Pharmaceuticals unit, said the company would be able to ship nearly 4 million doses of its COVID-19 vaccine upon authorization and 20 million doses by the end of March.

Additional doses could also come from AstraZeneca Plc and from Novavax Inc, which are currently running clinical trials of their experimental vaccines.

An AstraZeneca executive said the drugmaker could supply doses necessary to vaccinate another 25 million people by the end of April if their vaccine is authorized by U.S. regulators.

(Reporting by Michael Erman; Editing by Bill Berkrot)

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)

4.2 million COVID-19 cases in November

WASHINGTON (Reuters) – The United States entered the final month of the year hoping that promising vaccine candidates will soon be approved to halt the rapidly spreading novel coronavirus after 4.2 million new cases were reported in November.

The new COVID-19 cases were more than double the previous monthly record set in October, as large numbers of Americans still refuse to refuse to wear masks and continue to gather in holiday crowds, against the recommendation of experts.

A Food and Drug Administration panel of outside advisers will meet on Dec. 10 to discuss whether to recommend the FDA authorize emergency use of a vaccine developed by Pfizer Inc.

A second candidate from Moderna Inc could follow a week later, officials have said, raising hopes that Americans could start receiving inoculations before the end the year, although widespread vaccinations could take months.

Other global pharmaceuticals including AstraZeneca PLC and Johnson & Johnson also have vaccines in the works, leading a member of the Trump administration’s “Operation Warp Speed” program to predict the country could be vaccinated by June.

“One hundred percent of the Americans that want the vaccine will have the vaccine by (June). We will have over 300 million doses available to the American public well before then,” Paul Ostrowski, the vaccine program’s director of supply, production and distribution, told MSNBC television on Monday.

In the meantime, leading health officials are pleading with Americans to follow their recommendations and help arrest a pandemic that killed more than 36,000 people in November, pushing hospitalizations to a record high of nearly 93,000 on Sunday, according to a Reuters tally.

The widespread impact of the pandemic has led Merriam-Webster to choose “pandemic” as the Word of the Year after it racked up the most online dictionary lookups of any word.

“Sometimes a single word defines an era, and it’s fitting that in this exceptional – and exceptionally difficult – year, a single word came immediately to the fore,” the dictionary publisher said.

In the absence of a federal blueprint to curb the spread of the virus, states are issuing new or revamped restrictions on businesses and social life.

California’s governor said he may renew a stay-at-home order in the coming days, warning that ICU admissions are on track to exceed statewide capacity by mid-December unless public health policies and social behavior change.

“The red flags are flying,” Governor Gavin Newsom told reporters in an online briefing. “If these trends continue, we’re going to have to take much more dramatic, arguably drastic, action.”

(Reporting by Reuters staff; Writing by Daniel Trotta; Editing by Bernadette Baum)

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 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)

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)