Departing FDA regulators pan Covid boosters in paper

“Even in population groups with relatively high vaccination rates, the unvaccinated are still the main drivers of transmission and are themselves exposed to the highest risk of serious illnesses,” write the authors, who also include scientists from the World Health Organization.

Even if booster vaccination turns out to reduce the risk of serious diseases, it would be better to distribute existing supplies to unvaccinated corners of the world rather than strengthening the vaccinated population to prevent further variants from developing.

“Careful and public scrutiny of the evolving data will be needed to ensure that funding decisions are made more by reliable science than policy,” they wrote.

The authors point out that reinforcement may still be necessary in the future if the protection wears off before the first shots or a variant develops that eludes this protection. They also recognize the potential benefits of immediate empowerment for immunocompromised patients who may not have built an adequate immune response to their initial series of vaccines.

Now is the time to study variant-based boosters while the primary vaccines remain effective, they said, noting the similar strategy used to schedule the annual flu shot.

Background: Some members of the Centers for Disease Control and Prevention’s External Vaccine Advisory Committee last month raised similar concerns about the increase in the general population, suggesting the White House was ahead of government scientists in announcing plans To offer vaccinations on a broad basis from September 20th.

CDC officials also warned against signing boosters without sufficient data, and the committee chair stressed that preventing serious illness, hospitalizations and deaths should be the goals of the US vaccination program, rather than eliminating the virus entirely.

The warnings: Messages on boosters could undermine confidence in the vaccine, including the perceived value of initial vaccination schedules, if not backed by robust data, the authors said. They warned against using boosters too quickly, arguing that there should be “clear evidence” that they are safe, given the serious side effects already observed, such as myocarditis and Guillain-Barré syndrome. If an early booster causes serious side effects, it could have effects on vaccine uptake beyond COVID-19 vaccines.

“Public health officials should also carefully weigh the ramifications for primary vaccination campaigns in advocating boosters for only selected vaccines,” they said. CDC officials raised this prospect when meeting outside advisors last month, suggesting a risk-based approach that initially focuses on frontline health workers and residents of long-term care homes.

Creating “clear public health messages prior to the increase is generally recommended” will be a crucial part of any introduction, they wrote.

What’s next: The FDA’s external advisory committee on vaccines will meet on Friday to discuss Pfizer’s request to offer booster doses to people aged 16 and over.

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