FDA Finally Recommends COVID-19 Booster Shots for All Adults

Friday’s announcement by the Food and Drug Administration was that they recommend COVID-19 booster shots to all adults in America. It is great news as America faces the possibility of a winter-related outbreak and the spread of the Delta variant. The rollout could be seriously hampered by the agency’s poor track record.

The new guidelines recommend single-dose boosters of either the Pfizer or Moderna vaccines for any American adult who has received either two doses of the Pfizer or Moderna shots, or one dose of the Johnson & Johnson vaccine. The FDA announced that single-dose boosters of vaccines were not available prior to today’s approvals.[were only]Authorized to be administered to people 65+, to those aged 18 to 64 years who are at highest risk for severe COVID-19 or to those aged 18 to 64 years with frequent exposures to SARS-CoV-2 in their workplaces and institutions.

This news does not include the complicated process between. The President Joe Biden had recommended that boosters be authorized for all adults by September 20. The FDA acting commissioner and White House COVID-19 czar both endorsed the plan, but internally the FDA disagreed, feeling it was more important to prioritize shots for children under 13—despite the fact that it was already known by then that unvaccinated children were about as safe from COVID-19 as vaccinated adults. Biden did not miss his deadline. He made the recommendation and the FDA then waited for two more months before authorizing booster shot authorizations for those who were most at risk.

During those two months there was ample evidence to support the safety and effectiveness of boosters. Moderna submitted its first data regarding the efficacy of its third-dose booster vaccine on September 1. Two weeks later, on September 15, it released updated information on long-term effectiveness, demonstrating that while still highly effective long after receiving the two initial doses, “The increased risk of breakthrough infections…illustrates the impact of waning immunity and supports the need for a booster to maintain high levels of protection.”

Israel had seen widespread success in controlling outbreaks by mid-October. This was partly due to the authorization of Pfizer boosters that were available for children 12 years and older. The number of severe breakthroughs has declined and the incidence of rare but serious side effects such as myocarditis among teenagers and young adults is declining.

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Yet, FDA’s inconsistencies on this subject were rarely met with the same seriousness as the current moment. Scott Gottlieb, a former FDA commissioner, told CBS’s Face the Nation This pandemic’s biggest opportunity was missed because of “the confused message about boosters.” Rochelle Wilensky, director of the Centers for Disease Control and Prevention, reaffirmed the decision to not include high-risk workers in their initial authorization for vulnerable people. However, she included them anyway. It doesn’t matter if her decision was right, but the way it was executed undermines its message.

Recent days have seen Ashish Jha (dean of Brown University’s School of Public Health) give the clearest and most authoritative advice on boosters. This is my first article. AtlanticIn an openly written article titled “You should get a booster now!” Jha clearly explains the truth of current circumstances: Although the Pfizer/Moderna vaccinations provide high levels of immunity over the long-term, they are less effective. Unvaccinated persons are three times more likely than those who were vaccinated to contract the disease and die. It is possible to get a breakthrough infection, but if the spread of the disease is large enough, it can pose a danger for those who are vaccinated. Boosters, which are very effective and cost-effective, are the best way to protect the elderly as well the wider public. The FDA’s inability to clearly communicate those facts up to now is beyond comprehension.

It seems that all adults who have been vaccinated for at least 6 months should be able to get a booster. Yet, FDA and CDC have been doing such a terrible job that trust is low among the general public. To the extent booster messages can be communicated to the population, this will not happen because of the agencies.