FDA advisory panel to review Johnson & Johnson COVID-19 vaccine with thumbs up expected

By Manas Mishra and Michael Erman

(Reuters) – A panel of expert advisers to the U.S. Food and Drug Administration began a meeting to discuss Johnson & Johnson’s one-dose COVID-19 vaccine on Friday, setting the stage for a possible emergency use authorization as early as this week.

After it receives the recommendation, the FDA is likely to authorize the vaccine for emergency use within a day or so, making it the third available in the United States, and the only one that requires just one shot.

The panel, consisting of doctors, infectious disease experts and medical researchers, began the meeting at 9:00 a.m. ET (1400 GMT), and will vote in favor or against the vaccine’s use several hours later at the end of the meeting.

The panel will consider whether the benefits of the vaccine outweigh its risk for use in people aged 18 and older.

In a 44,000-person trial, the vaccine overall was 66% effective at preventing moderate-to-severe cases of COVID-19 compared with a placebo.

The effectiveness of the one-dose vaccine varied over time and location. In the United States, the effectiveness was 74% at 14 days and 72% two weeks later, while the shot was 64% effective at stopping moderate-to-severe COVID-19 after 28 days in South Africa, where a worrying new variant has swept across the country.

The vaccine was 100% effective at preventing hospitalizations 28 days after vaccination and there were no COVID-19 deaths among those who received the shot.

“In the context of the pandemic, the FDA is likely to issue an emergency use authorization (EUA) based on the data,” said UBS analyst Navin Jacob ahead of the panel meeting.

The J&J vaccine can be stored in normal refrigerator temperatures, making distribution easier than that of the Pfizer Inc/BioNTech SE and Moderna Inc vaccines that use mRNA technology and must be shipped and stored frozen.

J&J’s vaccine uses a common cold virus known as adenovirus type 26 to introduce coronavirus proteins into cells in the body and trigger an immune response.

Three to four million doses of the vaccine are expected to be rolled out next week.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in New York; Editing by Caroline Humer, Bill Berkrot and Shounak Dasgupta)

Johnson & Johnson’s one-shot COVID-19 vaccine effective and safe: FDA staff

(Reuters) – Johnson & Johnson’s one-shot COVID-19 vaccine appeared safe and effective in trials, U.S. Food and Drug Administration (FDA) staff said in documents published on Wednesday, paving the way for its approval for emergency use.

The FDA’s panel of independent experts meets on Friday to decide whether to approve the shot. While it is not bound to follow the advice of its experts, the FDA usually does and has authorized vaccines from Pfizer and Moderna.

J&J said in documents submitted to the FDA that its data suggested its vaccine was effective at preventing asymptomatic infections. It said that in a preliminary analysis of its trial, it found 16 cases of asymptomatic cases in the placebo group versus two in the vaccine group, or an 88% efficacy rate.

While asymptomatic infection was not the primary goal of the trial, which studied the vaccine’s ability to stop moderate to severe COVID-19, the reduction of asymptomatic cases implies the shot can also cut transmission of the disease.

J&J’s vaccine was 66% effective in preventing COVID-19 against multiple variants in a global trial involving nearly 44,000 people, the company said last month.

Its effectiveness varied from 72% in the United States to 66% in Latin America and 57% in South Africa, where a new variant has spread, though the vaccine was 85% effective overall in stopping severe cases of the disease.

The vaccine was effective in reducing the risk of COVID-19 and preventing PCR-test confirmed COVID-19 at least 14 days after vaccination, the FDA said in its briefing documents.

Fourteen days after injection, only two vaccine recipients developed COVID-19 severe enough to need medical intervention, compared with 14 in the placebo group. After 28 days, no vaccine recipients developed COVID severe enough to require medical intervention whereas seven in the placebo group did.

Three vaccine recipients had severe side effects in the trial that were likely related to the vaccine, but the FDA said its analysis did not raise any specific safety concerns that would preclude issuance of an emergency use authorization.

The FDA said the most common solicited adverse reactions were injection site pain at 48.6%, headache at 39%, fatigue at 38.2% and myalgia at 33.2%. Other side effects included a fever in 9% of participants and a high fever in 0.2% of those who received the vaccine.

The regulator said one case of pericarditis, a heart disease, may have been caused by the vaccine. It said cases of a rare disorder, Guillain-Barre Syndrome, were unlikely to be related to the shot though data was insufficient to determine whether or not the vaccine had caused these side effects.

J&J had not previously released details of its clinical trial data beyond efficacy rates.

(Reporting by Manas Mishra in Bengaluru; Mike Erman, Caroline Humer and Rebecca Spalding; Editing by Bernard Orr and David Clarke)

Trials of retooled vaccines for variants could take months: U.S. FDA

By Michael Erman

(Reuters) – Drugmakers should test any COVID-19 vaccines that have been retooled to combat new variants of the coronavirus in clinical trials designed to track the immune response of hundreds of test subjects, which could take months, U.S. regulators said on Monday.

Vaccine developers may need to modify their shots to provide protection against new variants of the coronavirus that turn up in the United States should they fail to elicit immune response in their current form, the U.S. Food and Drug Administration said in a statement.

The FDA said it believes currently authorized vaccines from Pfizer Inc with partner BioNTech SE and Moderna Inc. are effective against variants currently circulating in the United States.

Acting FDA Commissioner Janet Woodcock said drugmakers should not wait until a mutated virus is demonstrated to be able to escape the vaccines to begin developing new versions.

“We need to anticipate this and work on it, so that we have something in our back pocket before the threshold is upon us,” she said at a news conference.

The emergence of new, more contagious variants has prompted the U.S. government to step up efforts to track coronavirus mutations and try to keep vaccines and treatments effective against any new variants.

Pfizer and Moderna have both said they plan to run clinical trials of versions of their vaccine that have been redesigned to combat the highly contagious COVID-19 variant that has become prevalent South Africa and has turned up in several U.S. States.

The FDA made the comments as part of a newly updated guidance for companies making vaccines, tests and therapeutics for COVID-19.

As part of its updated guidance, the FDA recommended that vaccine makers test any modified vaccines in both previously unvaccinated people and vaccinated people. The manufacturers should compare the immune response of a modified vaccine against both the new variant as well as the original virus.

The FDA also recommended monitoring test subjects’ safety for at least seven days, to support emergency use authorization for modified vaccines.

The agency is trying to allow drugmakers to make the change with a minimal amount of extra data needed, said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

Still, the type of trial the agency wants, “might take a few months, whether it be two or three,” Marks said. “I can’t say exactly how long but again, that type of the scale of the amount of time.”

“We want to be ready so that we can move it into production, when it’s ready and when it’s needed,” he said.

(Additional reporting by Manojna Maddipatla and Mrinalika Roy in Bengaluru; Editing by Jonathan Oatis and 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)

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)