US experts convene to decide whether to OK Pfizer vaccine

7 min readDec 10, 2020

A U.S. government advisory panel convened on Thursday to decide whether to endorse mass use of Pfizer’s COVID-19 vaccine to help conquer the outbreak that has killed close to 300,000 Americans.

The meeting of outside advisers to the Food and Drug Administration represented the next-to-last hurdle before the expected start of the biggest vaccination campaign in U.S. history. Depending on how fast the FDA signs off on the panel’s recommendation, shots could begin within days.

The FDA panel functions like a science court. During the scheduled daylong session, it was expected to debate and pick apart the data — in public and live-streamed — on whether the vaccine is safe and effective enough to be cleared for emergency use.

“The American public demands and deserves a rigorous, comprehensive and independent review of the data,” said FDA’s Dr. Doran Fink, who described agency scientists working nights, weekends and over Thanksgiving to get that done.

With unprecedented interest in the normally obscure panel, the FDA broadcast the meeting via Youtube, and thousands logged on to follow the discussion.

The FDA is not required to follow the committee’s advice but is widely expected to do so. Once that happens, the U.S. will begin shipping millions of doses of the shot.

The meeting came as the coronavirus continues surging across much of the world, claiming more than 1.5 million lives, including more than 289,000 in the U.S.

Hanging over the meeting is a warning from British officials that people with a history of serious allergic reactions shouldn’t get the vaccine. Government officials there are investigating two reports of reactions that occurred when the country began mass vaccinations on Tuesday.

Still, a positive recommendation and speedy U.S. approval appeared nearly certain after FDA scientists issued an overwhelmingly positive initial review of the vaccine earlier this week.

FDA said results from Pfizer’s large, ongoing study showed that the shot, which was developed with Germany’s BioNTech, was more than 90% effective across people of different ages, races and underlying health conditions, including diabetes and obesity. No major safety problems were uncovered, and common vaccine-related side effects like fever, fatigue and injection site pain were tolerable.

“The data presented in the briefing report were consistent with what we heard before and are really exciting,” said Dr. William Moss, head of Johns Hopkins University’s International Vaccine Access Center. “Nothing that I see would delay an emergency use authorization.”

The meeting also represented an opportunity for regulators to try to boost public confidence in the breakneck development process that has produced the Pfizer-BioNTech vaccine and a string of other upcoming shots in less than a year.

The FDA has also faced weeks of criticism from President Donald Trump for not rushing out a vaccine before Election Day.

“There have been a lot of questions about why it takes us so long or ‘are we being rigorous enough?’” said FDA Commissioner Stephen Hahn in an interview. “I’m hoping that people will see with our transparency that we have taken a very rigorous stance on this.”

Hahn said the agency had already teed up the process to authorize the vaccine by filling out all the legal paperwork in advance, regardless of the ultimate decision.

On Thursday’s agenda:

RARE ADVERSE REACTIONS

The FDA uncovered no major safety problems in its review of Pfizer’s 44,000-person study, including no allergic reactions of the type reported in Britain. But such studies can’t detect rare problems that might only affect a tiny slice of the general population.

FDA reviewers noted four cases of Bell’s palsy that occurred among people getting the vaccine. They concluded the cases were probably unrelated to the vaccine because they occurred at rates that would be expected without any medical intervention. But the agency did say cases of the nerve disorder should be tracked, given that other vaccines can cause the problem.

“I think we have to be upfront, without scaring people, that we don’t know yet about any potential, rare, long-term adverse events,” Moss said.

EFFICACY QUESTIONS

The FDA found the vaccine highly effective across various demographic groups. But it’s unclear how well the vaccine works in people with HIV and other immune-system disorders.

The study excluded pregnant women, but experts will tease apart the data for any hints in case women get vaccinated before realizing they’re pregnant.

A study of children as young as 12 is underway.

IMPACT OF EMERGENCY AUTHORIZATION

Answering some of these questions will require keeping Pfizer’s study going for many more months.

When the FDA panel met in October, experts warned against allowing trial participants who received placebos to switch and get the real vaccine immediately after it receives the FDA’s emergency OK. Doing that could make it impossible to get answers to long-term questions, including how long the protection lasts.

Pfizer and BioNTech say they want to allow such participants to get the vaccine either upon request or, at the latest, after six months of follow-up. The FDA still hasn’t made clear if it will accept that approach.

“FDA is adamant that they want these trials completed,” said Norman Baylor, former director of FDA’s vaccine office.

A vast expanse of Amazon rainforest seven times larger than Greater London was destroyed over the last year as deforestation surged to a 12-year high under Brazil’s far-right president Jair Bolsonaro.

Figures released by the Brazilian space institute, Inpe, on Monday showed at least 11,088 sq km of rainforest was razed between August 2019 and July this year — the highest figure since 2008.

Carlos Rittl, a Brazilian environmentalist who works at Germany’s Institute for Advanced Sustainability Studies, said the numbers were “humiliating, shameful and outrageous” — and a clear sign of the damage being done to the environment since Bolsonaro took office in January 2019.

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“This is an area a third the size of Belgium — gigantic areas of forest that are being lost simply because under Bolsonaro those who are doing the destroying feel no fear of being punished,” Rittl said.

“Bolsonaro’s great achievement when it comes to the environment has been this tragic destruction of forests which has turned Brazil into perhaps one of the greatest enemies of the global environment and into an international pariah too.”

Brazil’s vice-president, Hamilton Mourão, tried to put a positive spin on the bleak figures as he visited Inpe’s headquarters in the city of São José dos Campos on Monday. Mourão claimed the annual increase of 9.5% was less than half the anticipated figure of about 20%.

“We’re not here to commemorate any of this, because it’s nothing to commemorate. But it means that the efforts being launched [against Amazon deforestation] are starting to yield fruit,” Mourão claimed.

Environmentalists, who blame Bolsonaro’s deliberate weakening of enforcement efforts for the rise, scoffed at that reading. “This number is an outrage — it doesn’t tell us anything positive about the Bolsonaro administration at all. On the contrary, it shows that despite the [Covid-19] quarantine, environmental crime has increased,” Rittl said.

Mourão’s comment about the smaller-than-expected rise was “like saying that we were expecting 300,000 Covid deaths and we ‘only’ had 200,000,” Rittl added.

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Cristiane Mazzetti, a Greenpeace spokesperson for the Amazon, said: “This is an even worse number than 2019 and a direct reflection of the Bolsonaro administration’s anti-environmental policies which have weakened the monitoring agencies and used misguided strategies to fight deforestation, such as deploying the armed forces rather than environmental protection agents.”

“These numbers show us that we are continuing to move in the wrong direction than the one needed to deal with the climate emergency and the biodiversity crisis.”

The Observatório do Clima group said soaring destruction came as no surprise to those “following the dismantling of environmental policy that has been underway in Brazil since January 2019”.

“The numbers simply show that Jair Bolsonaro’s plan has worked. They are the result of a successful project to annihilate the ability of the Brazilian state and its monitoring agencies to care for our forests and fight crime in the Amazon,” it said in a statement.

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Mourão said the figures, which were produced with information from the Prodes satellite system, showed most of the devastation was occurring in four regions: Pará state, the north of Mato Grosso state, the south of Amazonas state and Rondônia.

Pará, a longtime deforestation hotspot, was by far the worst-affected state accounting for almost 47% of the total deforestation.

“Thanks to Inpe’s work we now have a perfect sense of where we need to focus our actions in order to prevent illegal activities occurring,” Mourão told reporters, praising its “brilliant scientists” for their efforts.

But despite a growing “green” government propaganda campaign — which recently saw Mourão take foreign ambassadors on a tour of the Amazon region — environmentalists and foreign investors are skeptical about its efforts to protect the world’s biggest rainforest.

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During that three-day excursion ambassadors were not taken to any of the deforestation hotspots which Mourão detailed on Monday — and activists dismissed the visit as a “sham”.

In May thousands of Brazilian troops were sent to the Amazon supposedly to fight environmental crime, although some believe they are merely making things worse.

Rittl said one ray of light was the recent defeat of Bolsonaro’s key international ally, Donald Trump. “Without the backing of Trump in the US, the international pressure [on Bolsonaro over the environment] will increase and it will increase a lot,” he predicted.

Bolsonaro is one of only a tiny group of world leaders who has yet to recognise Joe Biden’s victory and on Sunday claimed, without proof, that unnamed “sources” had convinced him the US election had been plagued with fraud.

US experts convene to decide whether to OK Pfizer vaccine

Written by Pasoye

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