FDA Authorizes Covid Booster Shots For Immunocompromised Patients

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by Tyler Durden
Friday, Aug 13, 2021 - 08:14 AM

After growing chatter over the past week, late on Thursday the U.S. Food and Drug Administration authorized booster shots for certain people with weakened immune systems, likely the launch of broader efforts to better protect against evasive variants like Delta. The agency said that other fully vaccinated individuals do not need an additional vaccine dose right now, clarifying that the clearance is specifically for solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

“After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines,” Acting FDA Commissioner Janet Woodcock said in a statement. She said other people who are fully vaccinated are adequately protected and don’t need an additional dose at this time. The agency is reviewing whether an additional dose may be needed in the future, she said.

The decision expanding the authorization of the mRNA shots follows "scientific evidence" that vaccines are less effective at protecting people with weakened immune systems from Covid-19 than the general population. Immunocompromised people who didn’t have an antibody response after two doses of the mRNA vaccines had responses after a third dose, studies indicated, supporting the decision to recommend a third dose. About 2.7% of American adults are immunocompromised, which also includes people who live with HIV or take cancer treatments and other drugs that suppress their immune systems.

We expect the "scientific evidence" to expand to include everyone just as soon as Pfizer sees a dip in its revenue projections.

“This action is about ensuring our most vulnerable, who may need an additional dose to enhance their biological responses to the vaccines, are better protected against Covid-19,” Centers for Disease Control and Prevention Director Rochelle Walensky said.

“An additional dose could help increase protection for these individuals, which is especially important as the Delta variant spreads,” she added.

The expanded authorization is expected to be the first step in a broader campaign to get ahead of the evolving coronavirus, which has mutated into more contagious strains. A few other countries, such as Israel and Germany, plan to or have already administered the third shot to avoid another crisis due to the contagious Delta variant of the coronavirus.

Scientists are still divided over the broad use of COVID-19 vaccine boosters among those without underlying problems as benefits of the boosters remain undetermined.

Authorized vaccines appear to work well against the new strains that have emerged so far, especially protecting people against severe Covid-19, according to studies. Yet the shots don’t appear to be quite as effective as they were against the original virus, many studies indicate. Some other, preliminary research suggests that the protection conferred by vaccination wanes over time.

As noted yesterday, Pfizer has said the efficacy of the vaccine it developed with BioNTech drops over time, citing a study that showed 84% effectiveness from a peak of 96% four months after a second dose. Moderna has also said it sees the eventual need for booster doses, especially since the Delta variant has caused "breakthrough" infections in fully vaccinated people.

The U.S. health regulator on Thursday amended the emergency use authorizations for the vaccines to allow an additional dose in certain individuals, specifically for recipients of solid organ transplant or those diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

Reports of infections among vaccinated people and concerns about diminishing protection have galvanized wealthy nations to distribute booster shots, even as many countries struggle to access first vaccine doses.

The World Health Organization last week called for a moratorium on COVID-19 vaccine booster shots until at least the end of September.

Spurred by the Delta variant, coronavirus cases in the United States have spiked to their highest levels in more than six months, according to a Reuters tally. With U.S. health officials have saying that those with weak immune systems may not be sufficiently protected by their existing COVID-19 vaccinations, 

U.S. regulators must fully authorize the COVID-19 vaccines or amend their emergency use approvals before officials can recommend additional shots. A panel of advisers to the U.S. Centers for Disease Control and Prevention will meet on Friday to discuss eligibility of immunocompromised individuals for booster doses.

To maintain high levels of protection, some public-health experts and vaccine makers have recommended giving boosters to the general public. The Biden administration is expected to decide on a broader booster strategy by September. And since the midterms are in over a year, and mail-in "voting" has to be the only option by then for obvious reason, we expect that this round of booster shots will be extended by another, and then another, until all the votes are "counted."