Tag Archives: FDA

High levels of toxic heavy metals found in some baby foods: report

WASHINGTON (Reuters) – U.S. congressional investigators found “dangerous levels of toxic heavy metals” in certain baby foods that could cause neurological damage, a House Oversight subcommittee said in a report released on Thursday.

The panel examined baby foods made by Nurture Inc, Hain Celestial Group Inc, Beech-Nut Nutrition and Gerber, it said, adding that it was “greatly concerned” that Walmart Inc, Campbell Soup Co and Sprout Organic Foods refused to cooperate with the investigation.

The report said internal company standards “permit dangerously high levels of toxic heavy metals, and documents revealed that the manufacturers have often sold foods that exceeded those levels.”

Campbell said in a statement on its website that its products are safe and cited the lack of a current FDA standard for heavy metals in baby food. The company said it thought it had been “full partners” in the study with congressional researchers.

Walmart did not immediately respond to a request for comment. Hain could not immediately be reached for comment.

The report was critical also of the administration of then-President Donald Trump, saying it “ignored a secret industry presentation to federal regulators revealing increased risks of toxic heavy metals in baby foods.”

The report said “in 100% of the Hain baby foods tested, inorganic arsenic levels were higher in the finished baby food than the company estimated they would be based on individual ingredient testing.”

It said that in August 2019 the FDA received a secret slide presentation from Hain that said “corporate policies to test only ingredients, not final products, under represent the levels of toxic heavy metals in baby foods.”

The report said the FDA took no new action in response. “To this day, baby foods containing toxic heavy metals bear no label or warning to parents. Manufacturers are free to test only ingredients, or, for the vast majority of baby foods, to conduct no testing at all,” the report said.

The Food and Drug Administration (FDA) has declared that inorganic arsenic, lead, cadmium, and mercury are dangerous, particularly to infants and children. They have “no established health benefit” and “lead to illness, impairment, and in high doses, death.”

(Reporting by Susan Heavey and David Shepardson; Editing by Howard Goller)

Moderna’s coronavirus vaccine faces U.S. FDA expert panel review

(Reuters) – A panel of outside advisers to the U.S. Food and Drug Administration is expected to endorse emergency use of Moderna Inc’s coronavirus vaccine during a meeting on Thursday, as the nation prepares to roll out a second vaccine.

The panel vote on whether the vaccine’s benefits outweigh its risks is likely to come some time after 3 pm ET (2000 GMT), with an FDA authorization expected as soon as Friday.

This is the same committee of expert advisers that last week backed the COVID-19 vaccine from Pfizer Inc and German partner BioNTech SE, clearing the way for the FDA emergency use authorization (EUA) a day later.

That vaccine is being distributed throughout the country. A massive inoculation program began at U.S. hospitals on Monday.

The Moderna vaccine uses similar messenger RNA technology but with less onerous cold storage requirements than the Pfizer/BioNTech shot, making it a better option for remote and rural areas. Both vaccines were about 95% effective in preventing illness in pivotal clinical trials.

The FDA advisory committee is likely to discuss Moderna’s reports of side effects from its 30,000-person trial, which were more frequent than those reported by Pfizer. These were primarily relatively short-lived reactions to the vaccination rather than serious adverse events.

SVB Leerink analysts said the Moderna vaccine appears less tolerable than the Pfizer/BioNTech shot, but noted that is not a proper comparison across trials and unlikely to stand in the way of an EUA.

The FDA staff did not raise any serious concerns about safety in documents published on Tuesday in preparation for the meeting. It said a link between Bell’s palsy, which causes temporary paralysis of facial muscles, and the vaccine could not be ruled out after some cases were reported in trials of both vaccines.

Pfizer and BioNTech said those cases occurred at the same rate as in the general population.

Moderna is seeking authorization for people aged 18 and older. That could sidestep the lively discussion last week among panel members about whether there was enough data to authorize use of the Pfizer/BioNTech vaccine in adolescents aged 16 and 17. They ultimately voted to back that vaccine for those 16 and older.

Initial Moderna vaccine supply would likely go to the United States, which has signed deals to secure as many as 200 million doses and is expecting the first 20 million this month. The vaccine is administered in two doses about four weeks apart.

The company has also signed supply deals with Canada, the European Union and the UK. The vaccine is undergoing a “rolling review” by regulators for all three.

(Reporting by Manas Mishra in Bengaluru; Editing by Caroline Humer and Bill Berkrot)

U.S. COVID deaths smash daily record amid pleas to trim back Christmas

By Susan Heavey and Maria Caspani

WASHINGTON/NEW YORK (Reuters) – The daily U.S. death toll from COVID-19 has surpassed 3,000 for the first time, prompting pleas for Americans to scale back Christmas plans even with vaccines on the cusp of winning regulatory approval.

COVID-19 deaths reached 3,253 on Wednesday, pushing up the U.S. total since the start of the pandemic to 289,740. A record 106,219 people were hospitalized with the highly infectious respiratory disease.

Healthcare professionals and support staff, exhausted by demands of the pandemic, have been watching patients die alone as millions of Americans refuse to follow medical advice to wear masks and avoid crowds to contain the spread.

Nursing home residents and staff have also felt the burden.

“This is a pandemic that no one has ever experienced in our lifetimes,” Stephen Hanse, president of the New York State Health Facilities Association and the New York State Center for Assisted Living, told Reuters on Thursday.

The one-day death toll exceeded the number of lives lost from the attacks of Sept. 11, 2001, underscoring the human toll and the call for Americans to redouble efforts.

“No Christmas parties. There is not a safe Christmas party in this country right now,” Dr. Michael Osterholm told CNN on Thursday.

“It won’t end after that but that is the period right now where we could have a surge upon a surge upon a surge,” Osterholm said.

Potentially helping to rein in the outbreak, a vaccine could start reaching healthcare workers, first responders and nursing home residents within days in what Hanse called “light at the end of the tunnel.”

A panel of independent medical experts was due to decide on Thursday whether to recommend to the U.S. Food and Drug Administration a vaccine from Pfizer Inc and German partner BioNTech SE for emergency use authorization.

A vote was expected some time after 3:10 p.m. EST (2010 GMT).

FDA consent could come as early as Friday or Saturday, followed by the first U.S. injections on Sunday or Monday, Moncef Slaoui, chief adviser to the Trump administration’s Operation Warp Speed vaccine development program, told Fox News.

A second vaccine developed by Moderna is a week behind.

Biden, who succeeds President Donald Trump on Jan. 20, has set a goal of vaccinating 100 million people within the first 100 days of his administration.

In the meantime, intensive care units at hundreds of hospitals across the country were at or near capacity, data from the U.S. Department of Health and Human Services showed.

Ten mostly rural counties in California reported having no ICU beds on Wednesday, according to state health figures analyzed by Reuters.

Besides the human cost, the pandemic has forced millions out of work as state and local officials impose restrictions on social and economic life to contain the outbreak.

Congress, meanwhile, has struggled to end a months-long stalemate over economic assistance.

Disagreements remain over business liability protections demanded by Republicans and aid to state and local governments sought by Democrats before a final deal is reached on pandemic assistance.

(Reporting by Susan Heavey, Maria Caspani, Sharon Bernstein and Lisa Shumaker; Writing by Daniel Trotta; Editing by Bernadette Baum, Steve Orlofsky and Tom Brown)

Two coronavirus vaccines available in U.S. in coming weeks: health secretary

WASHINGTON (Reuters) – The first two vaccines against the novel coronavirus could be available to Americans before Christmas, Health Secretary Alex Azar said on Monday, after Moderna Inc became the second vaccine maker likely to receive U.S. emergency authorization.

The Food and Drug Administration’s outside advisers will meet on Dec. 10 to consider authorizing Pfizer Inc’s COVID-19 vaccine. That vaccine could be approved and shipped within days, with Moderna’s following one week behind that, Azar said.

“So we could be seeing both of these vaccines out and getting into people’s arms before Christmas,” Azar said on CBS’ “This Morning.”

The federal government will ship the vaccines through its normal vaccine distribution system, with state governors determining where they should go first, Azar said.

“They will be determining which groups to be prioritized. I would hope that the science and the evidence will be clear enough that our governors will follow the recommendations that we will make to them,” Azar said.

He said he and Vice President Mike Pence will speak to all the nation’s governors later on Monday to discuss the vaccines and which groups of people should be prioritized to get them first.

(Reporting by Doina Chiacu; Editing by Kevin Liffey)

U.S. hits highest death toll since May with hospitals already full

By Daniel Trotta

(Reuters) -Daily U.S. deaths from COVID-19 surpassed 2,000 for the first time since May and with hospitals across the country already full, portending a surge in mortalities to come as the coronavirus pandemic casts a shadow over the holiday season.

The death toll reached 2,157 on Tuesday – one person every 40 seconds – with another 170,000 people infected, numbers that experts say could grow with millions of Americans disregarding official warnings and traveling for Thursday’s Thanksgiving holiday.

The deadliest day in more than six months was still short of the record of 2,806 deaths on April 14, in the early stages of the pandemic, according to a Reuters tally of official data. That one-day figure is sometimes reported higher due to a backlog of deaths that were not compiled until April 14.

With U.S. hospitalizations for COVID-19 reaching a record high of 87,000 on Tuesday, the nation’s leading infectious diseases official urged people to keep Thanksgiving gatherings as small as possible.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, stressed the need to “hang in there a bit longer” on wearing masks, maintaining distance and avoiding crowds, especially indoors.

“If we do those things, we’re going to get through it. So that’s my final plea before the holiday,” Fauci told the ABC News program “Good Morning America” on Wednesday.

Families with university students have been forced to evaluate the risk of reuniting for Thanksgiving.

Francesca Wimer, a student at Northwestern University in Illinois, flew home to Washington wearing an N95 mask and a face shield and checked into a hotel for 14 days, quarantining to protect her parents and grandparents.

“She was returning to a vulnerable set of people. We didn’t trust that a test was enough,” said her mother, Cynthia Wimer.

Others are just staying put.

Luke Burke, studying at Syracuse University in upstate New York, was planning to spend Thanksgiving with his family in New Jersey until his roommate tested positive last week.

“I’m sorry I can’t be there with my parents, but it’s the right thing to do,” Burke said.

Meanwhile school districts across the United States face pressure from all sides as they grapple with how to educate children during the pandemic, a Reuters survey of 217 districts showed.

Many parents are balking at online instruction, while others worry about sending kids back into classrooms prematurely. Teachers say they are not comfortable teaching in person.

“Every school district across the nation is in the position in which no matter what decision they make and how well thought out it is, it will leave some in the community thinking it’s the wrong decision,” said Larry Rother, senior executive director of pre-kindergarten through 12th-grade educational services in Chandler, Arizona.

Help may be coming with vaccines showing promise.

Officials from the U.S. government’s Operation Warp Speed program told reporters on Tuesday they plan to release 6.4 million COVID-19 vaccine doses nationwide in an initial distribution after the first one is cleared by regulators for emergency use, which could happen as soon as Dec. 10.

If all goes well, 40 million doses will be distributed by the end of the year, they said.

A Food and Drug Administration ruling on emergency use for Pfizer Inc’s vaccine is expected on Dec. 10.

(Reporting by Daniel Trotta, Lisa Shumaker, Gabriella Borter, Lisa Lambert, Kristina Cooke, Benjamin Lesser, M.B. Pell and Simon Lewis; Editing by Chizu Nomiyama, Andrea Ricci and Jonathan Oatis)

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)

FDA approves first COVID-19 test kit for home use

(Reuters) – The U.S. Food and Drug Administration said on Tuesday it had approved the first COVID-19 self-testing kit for home use that provides results within 30 minutes.

The single-use test, made by Lucira Health, has been given emergency use authorization for home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19 by their health care provider, the FDA said.

“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,” FDA Commissioner Stephen Hahn said.

The kit can also be used at hospitals and point-of-care settings but samples should be collected by a healthcare provider if the individuals who are tested are younger than 14 years, the health regulator said.

Although a recent string of positive news from Moderna Inc and Pfizer Inc on their potential vaccines has raised hopes in combating the disease, testing still is a key factor in controlling the spread of the virus.

“We look forward to proactively working with test developers to support the availability of more at-home test options,” said Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health.

The United States crossed 11 million total infections on Sunday, just eight days after reaching the 10 million mark.

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

FDA to make emergency use authorization data public for COVID-19 vaccines

(Reuters) – The U.S. Food and Drug Administration said on Tuesday it would make public reviews of all data and information regarding the emergency use authorization (EUA) granted to COVID-19 drugs and vaccines.

“Today’s transparency action is just one of a number of steps we are taking to ensure public confidence in our EUA review process for drugs and biological products, especially any potential COVID-19 vaccines,” FDA Commissioner Stephen Hahn said in a statement.

Hahn said all FDA drug and biological product centers intend, “to the extent appropriate and permitted by law,” to share information about scientific review documents supporting the issuance, revision or revocation of EUAs.

Countries around the world are racing to develop COVID-19 vaccines and treatments, and the rapid pace of development has had doctors and experts concerned about transparency and regulatory reviews.

The FDA said it recognizes disclosing such information would also contribute to the public’s confidence in the agency’s rigorous review of scientific data.

“We will also continue to follow the science and ensure that science remains the driver of the agency’s regulatory decision-making in our fight against COVID-19 and beyond on behalf of public health,” Hahn said.

(Reporting by Vishwadha Chander in Bengaluru; Editing by Sriraj Kalluvila)

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)