FDA panel votes for Pfizer's booster shot for high risk, ages 65+

A U.S. Food and Drug Administration (FDA) advisory panel voted unanimously Friday to recommend Pfizer (PFE)/BioNTech's (BNTX) third dose for Americans 65 and older, and for those with high risk of contracting a severe case of COVID-19 — including health care and other workers.

The vote authorizing a booster for 65 and older was the panel's second decision of the afternoon, following a ruling against booster doses for Americans 16 and over. The second vote also approved emergency use authorization rather than a supplemental approval of the already fully-licensed vaccine.

A CDC advisory panel meeting, slated for next week, will delve further into who will qualify for the additional dose.

Dr. Lena Wen, visiting professor at George Washington University Milken Institute School of Public Health, told Yahoo Finance the vote achieved a balance.

The vote comes after a heated debate in recent weeks over the need for booster or additional shots, which both mRNA companies — Pfizer and Moderna (MRNA) — have advocated for.

"This is a reasonable 'middle ground' solution and gives discretion to physicians and patients to decide who is high risk. That level of individual decision-making is key," Wen said.

"Of course, it's true that the unvaccinated are the major problem when it comes to spread of covid, but it shouldn't mean that those vaccinated don't deserve to be better protected with an extra dose if they so choose," Wen added.

Dr. Peter Marks, the FDA's top expert on vaccines, touched on the recent controversy in his introductory remarks.

"We know that there may be differing opinions of the interpretation of the data regarding the potential need for additional doses, and we strongly encourage all the different viewpoints to be voiced and discussed regarding the data, which is complex, and evolving," Marks said.

He added the meeting focused on almost real-time analyses compared to what is happening in the world, and the goal remains slowing the spread of COVID-19, which is killing almost 2,000 Americans daily.

The question the advisory panel was originally given to consider only used the U.S. data, a small dataset, despite the presentations including data from the U.K. and Israel.

Marks instructed the panel to consider all the data, noting, "This is not a legal proceeding, this is a science proceeding, so you can take all the data into account."

But he also noted that the FDA is not obligated to follow the panel's recommendation.

The meeting precedes a September 20 start date for additional doses, announced last month by the White House COVID-19 Response Team, despite U.S. Centers for Disease Control and Prevention (CDC) data showing some Americans are already receiving third doses. Last month, the CDC recommended additional doses for immunocompromised people.

A CDC advisory panel will meet next week to discuss recommendations for who should receive a booster dose.

At a Response Team briefing Friday, U.S. Surgeon General Dr. Vivek Murthy said the administration is already communicating with pharmacies, nursing homes and state officials to help roll out additional doses.

But whether or not the average American also needed boosters had been a growing debate for weeks.

Measuring antibody levels after a vaccine, which tend to wane, versus relying on memory cells, which can recall how to fight the virus, as is typical in vaccinations, was at the heart of the debate in the science community.

A Pfizer official acknowledged that "its a much more complex story" than just antibody titers — even as the company relied on that data to advocate for additional doses.

Meanwhile, some who opposed third doses believed those doses could be better used in countries with low vaccination rates.

Marks also addressed that at the start of the meeting Friday, noting that the committee is only supposed to weigh on the data and need for shots, and not on global vaccine equity or operational concerns in rolling out a booster campaign in the U.S.

The decision Friday heavily leaned on data from Israel, as well as the U.K., which has been a point of concern.

Dr. Angela Rasmussen, research scientist at the Vaccine and Infectious Disease Organization at the University of Saskatchewan, told Yahoo Finance that there are some very important differences ini vaccination campaigns, demographics and other key comparison metrics between the three countries.

"You can make some broad conclusions based on another country’s data. But it's hard to make an apples to apples comparison," Rasmussen said.

Kathrin Jansen, senior vice president and head of vaccine research and development at Pfizer, said the company believes that boosters are a critical tool in controlling the spread.

“We thank the committee for their thoughtful review of the data and will work with the FDA following today’s meeting to address the committee’s questions, as we continue to believe in the benefits of a booster dose for a broader population," Jansen said in a statement Friday.

Lacking data

In days prior, both mRNA vaccine companies discussed and advocated for boosters.

A new report from the CDC Friday showed that Moderna's vaccine remained stronger in protecting against hospitalization compared to Pfizer and Johnson & Johnson (JNJ).

Both mRNA company CEOs have previously told Yahoo Finance that additional doses are inevitable. But when those doses will be needed — annually or sometime after a third shot — remains unknown.

Moderna president Stephen Hoge said as much in a recent interview.

"We don't really know" if a third shot will be the final or if more are needed, he said.

Pfizer CEO Albert Bourla penned an open letter advocating for boosters based on the company's clinical trial data and data from Israel.

But the FDA previously cautioned that some studies from Israel, including a few published this week, have not been independently verified by the regulatory agency.

Bourla also addressed the concerns about equitable distribution of vaccines globally.

"I believe ...that the introduction of booster doses should not change the number of doses that each country receives. No commitments already made by Pfizer to a country will change if boosters are approved," Bourla said.

Meanwhile, the U.S. is reportedly gearing up to buy an additional 500 million doses of the Pfizer vaccine for global donations, according to the Washington Post.

Infection versus severe illness

Complicating matters in the discussion of data Friday was the fact that U.S. and Israel differed in how they characterize severe illness from COVID-19. Still, the data largely focused on mild infections.

Dr. Marion Gruber, one of the FDA's top vaccine review experts who announced she was stepping down in October along with Dr. Philip Krause, said the data suggests the U.S. vaccines remain effective "in protecting against severe disease, however, some data suggest that effectiveness is waning."

Gruber was among the signatories of a shocking Lancet article earlier in the week, along with World Health Organization officials, arguing against the Biden administration's plan for boosters until the world had completed a first round of vaccines in all countries.

Data from Israel, presented at the FDA meeting Friday, showed waning in protection against infection, but protection against hospitalization and severe illness remains strong. That has been a reason for critics of additional doses to advocate against the need.

Moderna's Hoge noted that the additional doses are going to be necessary eventually, and will help against an anticipated surge of COVID-19 in the late fall and winter months.

Pfizer's data showed that efficacy against infection began to wane after about 6 months, which is why the committee faced a question to approve a booster in that time. Previously, the White House had announced an 8-month follow-up after the initial course. By comparison, Moderna is pursuing 8 months based on its data.

FDA scientists revealed in documents released this week that much of the data came from outside the U.S., largely due to the country's inability to gather data in the way Israel did.

Israeli officials said Friday they accrued the data, after it started boosters in July, in a coordinated effort with insurers and providers and the government. By comparison, the U.S. largely relies on public health offices at the state and local level — and if any choose to stop sharing, the federal government has no insight.

Follow Anjalee on Twitter @AnjKhem

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