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COVID-19 vaccine booster tensions mount between White House, CDC and FDA

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Facing the second-biggest wave of COVID-19 infections and waning popularity, President Biden has promised to launch an initiative to begin providing vaccine boosters starting September 20.

But the plan hinges upon FDA and CDC support, and some officials at the agencies remain unconvinced that boosters are immediately necessary.

Two departing senior FDA vaccine officials recently co-wrote an article published in The Lancet arguing that insufficient evidence exists to justify the case for boosters. “Even if boosting were eventually shown to decrease the medium-term risk of serious disease, current vaccine supplies could save more lives if used in previously unvaccinated populations than if used as boosters in vaccinated populations,” the paper argues. In addition, while the public could ultimately benefit from boosting, administering boosters before they are required could lead to an uptick in adverse events, according to The Lancet art…

COVID-19 vaccine booster tensions mount between White House, CDC and FDA

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Facing the second-biggest wave of COVID-19 infections and waning popularity, President Biden has promised to launch an initiative to begin providing vaccine boosters starting September 20.

But the plan hinges upon FDA and CDC support, and some officials at the agencies remain unconvinced that boosters are immediately necessary.

Two departing senior FDA vaccine officials recently co-wrote an article published in The Lancet arguing that insufficient evidence exists to justify the case for boosters. “Even if boosting were eventually shown to decrease the medium-term risk of serious disease, current vaccine supplies could save more lives if used in previously unvaccinated populations than if used as boosters in vaccinated populations,” the paper argues. In addition, while the public could ultimately benefit from boosting, administering boosters before they are required could lead to an…

FDA could soon greenlight COVID-19 vaccine boosters

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. DoD photo by Lisa Ferdinando.

While President Biden initially announced that COVID-19 boosters would be available by September 20, media reports suggested that the announcement caught FDA off guard.

White House chief medical advisor Dr. Anthony Fauci recently suggested in an interview with CBS’s “Face the Nation” that the U.S. government is scaling back its booster plan for the broader public, but that FDA could authorize Pfizer’s COVID-19 vaccine by September 20. The agency would authorize the Moderna vaccine afterward.

“The bottom line is very likely, at least part of the plan [to authorize mRNA boosters] will be implemented, but ultimately the entire plan will be,” Fauci said.

The U.S. will likely stick by its earlier plan to provide booster doses of mRNA vaccines eight months after administering the…

Full COVID-19 vaccination could ultimately mean three doses

Dr. Anthony Fauci

While mRNA vaccines from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) had 95% efficacy in Phase 3 clinical trials, their effectiveness in the real world has dropped with the rise of the Delta variant.

As a result, breakthrough infections have grown more common in people who have received two doses of mRNA vaccines.

Ultimately, full vaccination may require three doses, concluded Chief Medical Advisor to the President Dr. Anthony Fauci in a press briefing. While acknowledging that the FDA would need to make the final decision, “I must say from my own experience as an immunologist, I would not at all be surprised that the adequate full regimen for vaccination will likely be three doses,” Fauci said.

In the briefing, Fauci pointed to booster data emerging from Israel recently published in a preprint. The Pfizer-BioNTech vaccine led to a 70% to 84% risk reduction 14 days after admin…

Study finds Moderna’s COVID-19 vaccine drives a stronger antibody response than Pfizer’s

Research published in JAMA found the Moderna’s COVID-19 vaccine drove an antibody response that was more than two times greater than that of Pfizer’s.

Specifically, the Moderna mRNA-1273 vaccine generated post-second-dose antibody levels of 2,881 units per milliliter. Those who received the Pfizer-BioNTech BNT162b2 vaccine had antibody levels measuring 1,108 units per milliliter.

The study involved 1,647 fully vaccinated healthcare workers in Belgium.

Immune protection, however, involves more than antibody levels. Pfizer researchers found that recipients of their vaccine have immune protection 12 days after vaccination when there are low antibody levels, according to a STAT article.

In volunteers who had previously contracted COVID-19, the Moderna vaccine recipients generated antibody levels of 3,836 units per milliliter, while antibody levels in Pfizer-BioNTech vaccine recipients were 1,444 units per milliliter.

Some 688 volunt…

Third dose of Pfizer COVID-19 vaccine boosts protection in people over 60

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. DoD photo by Lisa Ferdinando.

Israeli researchers report that an additional dose of Pfizer (NYSE:PFE) and BioNTech’s (NISDQ:BNTX) COVID-19 vaccine leads to notable improvements in immunity in people 60 and older.

The protection against infection increased fourfold 10 days after administration of the third dose, according to scientists at the Gertner Institute (Ramat Gan, Israel) and KI Institute (Kfar Malal, Israel). In addition, patients who received a third dose had four to six times greater protection against severe illness and hospitalization.

In people over 60, a third dose was 86% effective in protecting against infection.

The country began distributing booster doses for people over 60 on July 30. In addition, Israel has recently made booster doses available to people 30 and older who had received…

Pfizer seeks FDA blessing for COVID-19 vaccine booster

Pfizer (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) aim to expand the recent FDA approval of their COVID-19 vaccine to include booster doses for individuals 16 and older.

The companies have submitted a supplemental Biologics License Application to the FDA, including Phase 3 data drawn from participants aged 15 to 55.

The latest data indicate that a third dose of the Comirnaty vaccine boosts antibody titers and continues to be well tolerated.

Get the full story from our sister site, Drug Discovery & Development.

Pfizer seeks FDA blessing for COVID-19 vaccine booster

Pfizer (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) aim to expand the recent FDA approval of their COVID-19 vaccine to include booster doses for individuals 16 and older.

The companies have submitted a supplemental Biologics License Application to the FDA, including Phase 3 data drawn from participants aged 15 to 55.

The latest data indicate that a third dose of the Comirnaty vaccine boosts antibody titers and continues to be well tolerated.

Trial investigators administered the booster between 4.8 and 8 months after giving the second dose of the COVID-19 vaccine.

The booster resulted in strong protection against the original or wild-type strain of SARS-CoV-2. Specifically, 99.5% of participants had a four-fold increase in neutralizing antibody levels after the third dose.

The most common side effects were similar to those from earlier doses, including injection-site soreness, fatigue, headache, muscle aches and chills.

The comp…

COVID-19 vaccine mandates likely to accelerate

Pfizer-BioNTech COVID-19 vaccine. [Image courtesy of Wikimedia Commons]

Now that the FDA has approved the BioNTech-Pfizer vaccine for those 16 and older, it is likely that vaccine mandates will become more common.

Following the approval of the vaccine, the Pentagon, CVS, Chevron, Disney World, New York and New Jersey schools, and other organizations have signaled their intent to enforce vaccine mandates.

Yesterday, President Joe Biden called on a variety of organizations to pursue vaccine mandates. “If you’re a business leader, a non-profit leader, a state or local leader, who has been waiting for full FDA approval to require vaccinations, I call on you now to do that,” he said.

“The pandemic of the unvaccinated is a tragedy that is preventable,” Biden said. “People are dying and will die who don’t have to.” People who haven’t been vaccinated should “do it now,” he urged.

The FDA approval…

FDA approves Pfizer’s COVID-19 vaccine

[Image courtesy of Wikipedia]The FDA today issued approval for Pfizer and BioNTech’s COVID-19 vaccine, making it the first to receive full approval in the U.S.

Approval covers the prevention of COVID-19 in individuals 16 years of age and older. The vaccine remains available under FDA emergency use authorization (EUA) for people who are 12 years of age to 15 years of age, as well as for the administration of a third (booster) dose in certain immunocompromised individuals.

Get the full story at our sister site, Drug Discovery & Development.

FDA approves Pfizer’s COVID-19 vaccine

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. DoD photo by Lisa Ferdinando.

The FDA today issued approval for Pfizer and BioNTech’s COVID-19 vaccine, making it the first to receive full approval in the U.S.

Approval covers the prevention of COVID-19 in individuals 16 years of age and older. The vaccine remains available under FDA emergency use authorization (EUA) for people who are 12 years of age to 15 years of age, as well as for the administration of a third (booster) dose in certain immunocompromised individuals.

Such approval could bring more vaccination requirements in the U.S. as many employers and organizations around the country had been holding off on vaccine mandates until full approval was granted.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have …

FDA allows Pfizer-BioNTech and Moderna boosters in the immunocompromised

The FDA has authorized boosters for certain vaccinated individuals, but the agency believes there is insufficient evidence to recommend boosters to the broader population. The amended EUA applies to the Pfizer-BioNTech or Moderna vaccines.

The individuals covered in the EUA include solid organ transplant recipients and people with other medical conditions leading to a moderate to severe state of immunocompromise.

Recipients of the Janssen vaccine are not currently eligible for a booster.

The amended EUA recommends that health officials administer the third dose at least 28 days after the second dose of the same vaccine. The EUA allows the use of the Moderna booster for patients who are 18 years old or older. It permits the administration of the third dose of Pfizer-BioNTech vaccine in individuals 12 or older.

“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are pa…