FDA Approves Boosters for Immunocompromised, Pfizer and Moderna Set to Reap Billions From Sales of Third Shot

The U.S. Food and Drug Administration (FDA) Thursday authorized the third dose of Pfizer-BioNTech and Moderna COVID vaccines for people with compromised immune systems.

Neither vaccine has yet received full FDA approval, and neither has completed late-stage clinical trials proving a third dose will boost immunity or work against COVID variants.

The amended Emergency Use Authorization allows people who have had an organ transplant, or those with a similar level of the weakened immune system, to get an extra COVID vaccine dose.

The FDA did not approve a Johnson & Johnson booster, citing insufficient data.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices today voted unanimously to recommend the CDC follow the FDA’s guidance by also approving the third shots for immunocompromised patients.

Thursday’s decision by the FDA “allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19,” Dr. Janet Woodcock, FDA acting commissioner, tweeted Thursday.

“Others who are fully vaccinated are adequately protected & do not need an additional dose of COVID-19 vaccine at this time,” Woodcock said in the tweet. The vulnerable group of patients eligible for the third shot makes up less than 3% of U.S. adults, according to Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC).

Israel started administering booster vaccines on July 12, to people 60 or older, and other countries plan to follow. On Aug. 13, Israel expanded the booster vaccination campaign to include people 50 years and older — a revision from the previous age eligibility requirement of 60 years and up.

Yet, Israeli Health Ministry data published Aug. 12 showed 14 Israelis had been infected with COVID a week after receiving a booster shot. Eleven people infected were 60 or older, and two were hospitalized — while the other three received a third dose because they are immunocompromised.

If confirmed in larger samples, the Internal Health Ministry said figures could cast doubt on the effectiveness of the booster shot, which Israel started administering before major health agencies around the world approved it.

The FDA’s authorization came as Biden administration officials and pharmaceutical companies appear increasingly convinced boosters for the broader population will be necessary.

Scientists are divided over the broad use of COVID vaccine boosters among those without underlying problems, as the benefits of the boosters remain undetermined.

Officials are scrutinizing data on the vaccines’ durability and discussing when extra shots might need to be administered and which groups might get priority, according to federal officials who spoke on the condition of anonymity.

Those officials told The Washington Post discussions have become increasingly urgent as some studies indicate a waning of the vaccines’ protection over time.

“No vaccine, at least not within this category, is going to have an indefinite amount of protection,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Thursday on NBC’s “Today” show. “Inevitably, there will be a time when we’ll have to get boosts.”

Safety and efficacy data on boosters lacking

At the end of July, Pfizer and BioNTech announced findings showing four to six months after a second dose, their vaccine’s efficacy dropped to about 84%.

Earlier this month, Moderna said its two-dose vaccine was 93% effective, with efficacy “remaining durable” through six months after the second dose. However, “neutralizing titers will continue to wane and eventually impact vaccine efficacy,” the company said. “Given this intersection, we believe dose 3 booster will likely be necessary prior to the winter season.”

Pfizer CEO Albert Bourla said he is “very, very confident” a booster will increase immunity levels in the vaccinated.

According to Kaiser Health News (KHN), Pfizer has not yet delivered conclusive proof to back up that confidence. The company lacks late-stage clinical trial results to confirm a booster will work against COVID variants, including Delta — which now accounts for 93% of new infections across the U.S.

Pfizer in July announced its global phase 3 trial — which assesses the safety, efficacy, and immunogenicity of a third dose — but the trial’s completion date isn’t until 2022.  Phase 3 results generally are required before regulatory approval, KHN reported.

“We are confident in this vaccine and the third dose, but you have to remember the vaccine efficacy study is still going on, so we need all the evidence to back up that,” Jerica Pitts, Pfizer’s director of global media relations, said Monday.

Moderna’s clinical trial “designed to assess the safety, reactogenicity and immunogenicity of a delayed vaccine boost” has an estimated primary completion date of May 28, 2023, and a study completion date of 2025.

The financial stakes are high for Pfizer, which announced in July it expects to pull in $33.5 billion in COVID vaccine revenue this year.

According to Reuters, Pfizer, along with German partner BioNTech, and Moderna have together locked up COVID vaccine supply agreements worth more than $60 billion in sales, just in 2021 and 2022. The agreements include the supply of the initial two doses of their vaccines as well as billions of dollars in potential boosters for wealthy nations.

Analysts forecasted revenue of more than $6.6 billion for Pfizer’s COVID vaccine 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.

Meanwhile, Pfizer recently said if a third dose couldn’t combat the Delta or other variants, the drugmaker is prepared to come up with a “tailor-made” vaccine within 100 days, KHN reported.

All of this has sown a sense of confusion about what exactly will work, and when. The pharmaceutical industry’s rush to recommend boosters for the public is “a little frustrating,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and an adviser to the National Institutes of Health and FDA.

Even if a booster is found to be safe, Offit said, the U.S. effort should focus on “vaccinating people who are unvaccinated.” In any case, decisions about boosters do not rest with vaccine makers, he said.

“Pharmaceutical companies aren’t public health agencies, it’s really not theirs to determine when or whether there should be booster dosing,” Offit said. “That is the purview of the CDC.”

Pfizer Fails to Convince FDA on Immediate Need for COVID Booster Shots

By Megan Redshaw | The Defender

After meeting with Pfizer executives Monday, U.S. regulators said they are still not ready to recommend COVID vaccine booster shots.

“Nothing has really changed,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN’s Chris Cuomo after the meeting.

Pfizer executives met privately with U.S. senior scientists and regulators Monday evening to press their case for quick authorization of COVID booster vaccines amid pushback from federal health agencies who last week said the extra doses are not needed.

Officials said after the meeting that more data — and possibly several more months — would be needed before regulators could determine whether booster shots were necessary.

During the 1-hour online virtual meeting, Pfizer’s chief scientific officer briefed top doctors in the federal government, including Fauci; Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC); Dr. Francis Collins, director of the National Institutes of Health; U.S. Surgeon General Dr. Vivek Murthy; Dr. Janet Woodcock, acting commissioner of the U.S. Food and Drug Administration (FDA); Assistant Secretary for Health Dr. Rachel Levine; and Dr. David Kessler, chief science officer of the Biden administration’s COVID response team.

The meeting was largely seen as a courtesy after Pfizer’s announcement last week that it would seek Emergency Use Authorization for its booster shot led to unusual pushback from the FDA and CDC.

The two agencies responded to Pfizer’s news in a joint statement, issued last week by the U.S. Department of Health and Human Services (HHS), in which they said fully vaccinated Americans don’t need boosters right now and the science is lacking.

“The CDC and the FDA said that based on the data that we know right now, we don’t need a boost,” Fauci told CNN Monday. “That doesn’t mean that that won’t change. We might need, as a matter of fact, at some time to give boosters either across the board or to certain select groups, such as the elderly or those with underlying conditions,” Fauci said.

Officials said any recommendations about booster shots are likely to be scaled, even within age groups. For example, if booster shots are recommended, they might go first to nursing home residents who received their vaccines in late 2020 or early 2021, while elderly people who received their first shots in the spring might have a longer wait, The New York Times reported.

Then there is the issue of what kind of booster will be needed: a third dose of the original vaccine, or a shot tailored to the Delta variant.

“It was an interesting meeting,” Fauci said. “They shared their data. There wasn’t anything resembling a decision. This is just one piece of a much bigger puzzle, and it’s one part of the data, so there isn’t a question of a convincing case one way or the other.”

Pfizer called the meeting “productive”:

“We had a productive meeting with U.S. public health officials on the elements of our research program and the preliminary booster data in our ongoing trials. Both Pfizer and the U.S. government share a sense of urgency in staying ahead of the virus that causes COVID-19, and we also agree that the scientific data will dictate next steps in the rigorous regulatory process that we always follow.”

Pfizer said it would be publishing “more definitive data in a peer-reviewed journal and continuing to work with regulatory authorities to ensure that our vaccine continues to offer the highest degree of protection possible.”

According to The New York Times, HHS, which convened the meeting, issued its own statement reiterating the administration’s stance. “At this time, fully vaccinated Americans do not need a booster shot,” the agency said.

An HHS spokesperson told CNN the CDC and FDA take laboratory data, clinical trial data, cohort data — which can include data from specific pharmaceutical companies but do “not rely on those data exclusively.”

The administration is prepared for booster doses if the science demonstrates they are needed, the spokesperson added and will continue to review any new data as it becomes available.

Prior to Monday’s meeting, Dr. Scott Gottlieb, former FDA commissioner and current board member at Pfizer, told CBS News that updated efficacy numbers from the Israeli Ministry of Health led Pfizer to seek Emergency Use Authorization for a booster dose of its COVID vaccine.

Israel’s health ministry said in a statement last week it had seen the efficacy of Pfizer’s vaccine drop from more than 90% to about 64% as the Delta variant spread.

As a result, Israel started administering a third dose of Pfizer’s COVID vaccine to immunocompromised people and heart transplant patients — despite the vaccine’s link to heart inflammation.

WHO says Pfizer should focus on improving access to vaccines, not boosters

World Health Organization (WHO) officials insisted there was not enough evidence to show the need for third doses of COVID vaccines. They said Pfizer should concentrate instead on improving vaccine access around the world, The Guardian reported.

The WHO Director-General Dr. Tedros Adhanom Ghebreyesus said grotesque vaccine disparities were driven by “greed.”

“We are making conscious choices right now not to protect those in need,” Ghebreyesus said, adding that people who have yet to receive a single dose should be prioritized. He  called on Pfizer and Moderna to “go all out to supply COVAX, the Africa Vaccine Acquisition Task Team, and low- and middle-income countries.”

Dr. Soumya Swaminathan, chief WHO scientist, said: “At this point … there is no scientific evidence to suggest that boosters are definitely needed.”

Swaminathan said the WHO would make recommendations on booster shots “based on the science and data, not on individual companies declaring that the vaccines should now be administered as a booster dose.”

Dr. Michael Ryan, WHO emergencies chief, suggested if rich countries decide to administer booster shots rather than to donate them to the developing world, “we will look back in anger and I think we will look back in shame.”

Pfizer stands to make billions from boosters

Pfizer stands to benefit financially if booster doses are needed, according to The Motley Fool which wrote: “The more COVID vaccine doses are required, the higher the companies’ sales will be and the better its vaccine stocks will likely perform.”

According to YAHOO Finance, Pfizer has recently experienced an increase in support from the world’s most elite money managers. Among these funds, Diamond Hill Capital held the most valuable stake in Pfizer — worth $407.3 million at the end of the fourth quarter.

In second place was New York-based hedge fund Two Sigma Advisors, which amassed $387.2 million worth of shares. Citadel Investment Group and AQR Capital Management — an investment management firm dedicated to delivering results for its clients — became one of the largest hedge fund holders of the company.

In terms of the portfolio weights assigned to each position, Healthcare Value Capital allocated the biggest weight to Pfizer.

Specific money managers include Marshall Wace LLP, which invested $56.1 million in the company at the end of the quarter, and Steven Boyd’s Armistice Capital, which made a $43.5 million investment in the stock during the quarter.

Other funds with brand new Pfizer positions are Charles Clough’s Clough Capital Partners, Michael Rockefeller and KarláKroeker’s Woodline Partners, and Phill Gross and Robert Atchinson’s Adage Capital Management.

As The Defender reported July 9, Pfizer CEO Albert Bourla has said for months a booster would likely be needed within a year of the initial two-dose inoculation — followed by annual vaccinations, even as public health officials and academic scientists said it wasn’t clear yet when a booster would be needed.

Booster shots for COVID are expected to serve as a key revenue driver in the years to come for Pfizer and its primary rival in the U.S., Moderna. Pfizer in May projected global sales of its COVID vaccine to reach $26 billion in 2021.

The company has also been frank that it’s current pricing — $19.50 per dose in the U.S. — is temporary. On an earnings call in February, Frank A. D’Amelio, Pfizer’s executive vice president of global supply, assured investors the company sees the vaccine market evolving as the pandemic wanes, and will likely be able to charge more per dose than it was getting under pandemic supply deals.

D’Amelio said a more typical price for vaccination was $150 or $175 per dose.

Pfizer has been working on two different booster strategies it anticipates could carry sales beyond the immediate pandemic need: a third 30 mg dose of its current vaccines and an updated vaccine that targets the South African variant.

The company said it would begin testing a booster shot specifically programmed to combat the Delta variant in August, reaffirming concerns by scientists who predicted in April that pharmaceutical companies like Pfizer, would create a vaccine treadmill with continuous booster shots targeted at emerging variants — which is music to the ears of investors.