Outgoing FDA vaccine officials co-author article explaining why vaccine boosters not currently needed



Two Food and Drug Administration officials who will be stepping down later this month co-authored a new medical article that questioned the need for COVID-19 vaccination booster shots.

What is the background?

Despite the proven efficacy of COVID vaccines, the Biden administration this summer began pushing for vaccine booster shots, claiming they are necessary to fortify COVID immunity.

But the campaign has been controversial. Two weeks ago, Dr. Marion Gruber, director of the FDA's Office of Vaccines Research and Review, and her deputy, Dr. Philip Krause, announced they would leave the agency in the coming months. According to Reuters, the FDA did not say why the pair was leaving the agency, despite Gruber, for example, having spent more than three decades with the FDA.

Politico later reported that Gruber and Krause had actually resigned in protest over the White House's micromanagement of vaccine plans:

A current health official said the pair, Marion Gruber and Philip Krause, left over differences with FDA's top vaccine official Peter Marks. Now the agency is facing a potential mutiny among its staff and outside vaccine advisers, several of whom feel cut out of key decisions and who view the plan to offer boosters to all adults as premature and unnecessary.

POLITICO spoke to 11 current and former health officials and people familiar with the matter who described growing exasperation with the administration's disjointed process for implementing its booster plan. Those sources said there is little coordination between federal health agencies, even as two top FDA officials try to guide the rollout.

What happened now?

In a newly published article in Lancet, a peer-reviewed medical journal, Gruber and Krause, along with 17 others, argued for the efficacy of the COVID-19 vaccines and cautioned against pushing booster shots.

"The vaccines that are currently available are safe, effective, and save lives," the medical experts wrote. "The limited supply of these vaccines will save the most lives if made available to people who are at appreciable risk of serious disease and have not yet received any vaccine. Even if some gain can ultimately be obtained from boosting, it will not outweigh the benefits of providing initial protection to the unvaccinated."

In fact, they explained that "currently available evidence does not show the need for widespread use of booster vaccination in populations that have received an effective primary vaccination regimen." That's because, as they earlier explained, "efficacy against severe disease remains high" in vaccinated populations, including infections caused by the delta variant.

The experts also warned about the political nature of booster advocacy.

"Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics," they wrote.

Who should get a booster?

They recommended that boosting "could be appropriate for some individuals in whom the primary vaccination ... might not have induced adequate protection," such as immunocompromised individuals and people who received a vaccine with low efficacy.

Still, they added a major qualifier to booster appropriateness for such individuals.

"People who did not respond robustly to the primary vaccination might also not respond well to a booster," the medical experts wrote.

Pfizer and Moderna expected to earn billions from COVID-19 booster shots



Pfizer/BioNTech and Moderna are forecasted to earn billions in sales from COVID-19 booster shots, Reuters reported, citing analysts and health care investors.

The vaccine makers have been saying that fully vaccinated people are expected to need booster shots as protection from initial doses of their shots diminish — and the U.S. Food and Drug Administration on Thursday OK'd boosters of both vaccines for people with compromised immune systems.

Big bottom lines

Pfizer/BioNTech and Moderna have nabbed over $60 billion in combined sales for the COVID-19 shots for 2021 and 2022, the outlet reported, adding that revenue generators include supplies of the initial two vaccine doses as well as potential boosters for wealthy nations.

More from Reuters:

Going forward, analysts have forecast revenue of over $6.6 billion for the Pfizer/BioNTech shot and $7.6 billion for Moderna in 2023, mostly from booster sales. They eventually see the annual market settling at around $5 billion or higher, with additional drugmakers competing for those sales.

The vaccine makers say that evidence of waning antibody levels in vaccinated people after six months, as well as an increasing rate of breakthrough infections in countries hit by the Delta variant, support the need for booster shots.

Some early data suggests that the Moderna vaccine, which delivers a higher dose at the outset, may be more durable than Pfizer's shot, but more research is needed to determine whether that is influenced by the age or underlying health of the people vaccinated.

As a result, it is far from clear how many people will need boosters, and how often. The profit potential of booster shots may be limited by the number of competitors who enter the market. In addition, some scientists question whether there is enough evidence that boosters are needed, particularly for younger, healthy people. The World Health Organization has asked governments to hold off on booster shots until more people worldwide receive their initial doses.

"We don't know what the market forces will be," Moderna President Stephen Hoge said in an interview last week, the outlet reported. "At some point, this will become a more traditional market — we'll look at what are the populations at risk, what value are we creating, and what are the number of products that serve that value. That will ultimately impact price."

Reuters said Pfizer declined to comment for its story, but the outlet noted that the drug company's executives have said they believe a third dose will be necessary six to eight months after initial vaccination — and then regularly afterward.

You can read the rest of the Reuters report here.

Moderna says third dose likely necessary this fall as antibody levels wane and impact vaccine's efficacy



Drugmaker Moderna says a third dose of its COVID-19 vaccine will "likely to be necessary this fall." The pharmaceutical and biotechnology company believes a booster shot will likely be necessary because the spread of the Delta variant and vaccine efficacy could be diminished since antibody levels were expected to wane.

"We believe that increased force of infection resulting from Delta, non-pharmaceutical intervention (NPI) fatigue, and seasonal effects (moving indoors) will lead to an increase of breakthrough infections in vaccinated individuals," Moderna said on Thursday. "While we see durable Phase 3 efficacy through 6 months, we expect neutralizing titers will continue to wane and eventually impact vaccine efficacy."

The vaccine maker noted, "Given this intersection, we believe dose 3 booster will likely be necessary prior to the winter season."

Moderna CEO Stéphane Bancel told Fox Business the company is "waiting for a bit more data," but the COVID-19 booster shot could be available "as soon as September" for elderly populations who received the COVID-19 vaccine in January and February.

"And so it's important that people who are vaccinated a long time ago, especially with vaccines that have had lower efficacy, be protected so they are not hospitalized this fall and winter," he told host Maria Bartiromo on Thursday.

On Wednesday, the World Health Organization implored wealthy nations to hold off on the coronavirus booster shots because of vaccine inequity.

"We need an urgent reversal from the majority of vaccines going to high-income countries, to the majority going to low income countries," WHO Director General Tedros Adhanom Ghebreyesus said at a press briefing.

Moderna claimed a study found its COVID-19 vaccine to be 93.2% effective against the coronavirus six months after the second dose, 98.2% effective against severe coronavirus maladies, and 100% effective in stopping death caused by COVID-19. The biotech company also boasted that its COVID-19 offers "effectiveness against variants of concern (VOCs), including Alpha, Beta/Gamma and Delta, even after partial vaccination."

"We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through six months, but recognize that the Delta variant is a significant new threat so we must remain vigilant," Bancel told CNBC on Thursday.

Moderna expects to manufacture between 800 million to 1 billion COVID-19 vaccine doses in 2021 worldwide, and forecasts to supply up to 3 billion doses in 2022.

The United States has administered over 348.1 million doses of COVID-19 vaccines as of Wednesday, Reuters reported. Broken down by manufacturer, there have been 195 million coronavirus vaccine doses from Pfizer-BioNTech administered, almost 140 million from Moderna, and more than 13 million from Johnson & Johnson, according to CDC data.

The COVID-19 vaccine announcements were made on Thursday during Moderna's second-quarter earnings presentation. Moderna boasted about second-quarter revenue of $4.4 billion, $4.2 billion of which came from COVID-19 vaccine sales, according to the financial announcement. Moderna said it had generated $4 billion of cash in the second quarter, and held a total of $12.2 billion in cash and investments.

Despite the notable financial news, Moderna shares fell 2.4% in the premarket.

Last month, Pfizer announced that it enjoyed second-quarter revenues of $7.8 billion, half of which came from its COVID-19 vaccine developed with Germany's BioNTech. Pfizer expects to generate $33.5 billion in COVID-19 sales in 2021.

During Thursday's presentation, Moderna also announced that it is working on mRNA-1010, a quadrivalent seasonal flu vaccine. The pharmaceutical company said the mRNA flu vaccine was entering Phase 2 trials, and is currently looking for trial participants in the U.S. and Puerto Rico.

Moderna is also working on mRNA-1345m, a vaccine for Respiratory syncytial virus (RSV), a "common respiratory virus that usually causes mild, cold-like symptoms," but can be "serious, especially for infants and older adults."