Latest Us News is The FDA approved omicron-specific vaccinations last month, backed by a frantic press statement and a media blitz. The Centers for Disease Control and Prevention quickly followed the FDA’s lead, recommending revised boosters for anybody aged 12 and above who had gotten at least two doses of the original covid vaccinations. The message to a country still reeling from the covid-19 pandemic: The cavalry, in the shape of a shot, is on its way over the hill.
However, for those familiar with pharmaceutical industry commercial practices, the enthusiastic message and lack of completed trials have created tremendous discomfort and generated a slew of unresolved questions.
Several members of the CDC advisory group, which voted 13-1 in favour of the plan, had similar issues and concerns, with one noting she only “reluctantly” voted in favour. That calculation is understandable because more than 300 Americans die from covid every day.
Did the US Jump the Gun With the New Omicron?
According to Latest US News, the FDA’s primary responsibility is to examine whether a new medicine is safe and effective. However, the FDA might have asked Pfizer and Moderna for further clinical vaccination efficacy data before approving their modified omicron BA.5 boosters.
We are grateful and astounded that Pfizer-BioNTech and Moderna (with assistance from the National Institutes of Health and Operation Warp Speed) created an effective vaccine in record time, rescuing the country from the darkest period of the covid epidemic when hundreds were dying every day.
This is a problem since the government will no longer be able to acquire covid vaccinations after this autumn. Funding for immunization provider fees and community engagement to individuals who might benefit the most from vaccination has already run out.
As a result, updated boosters will most likely be given to the “worried well” who have good insurance rather than those at the highest risk of infection and progression to severe illness.
However, the FDA cannot comment on critical follow-up questions: How much more effective are the new boosters than the existing vaccines? What populations? And what gain in efficacy is sufficient to justify a price increase (a so-called cost-benefit analysis)? Other nations, such as the United Kingdom, do such a study before releasing new drugs onto the market to negotiate reasonable national pricing.
Except for a change in the mRNA sequence to match the omicron BA.5 virus, the revised booster vaccine formulations are similar to the original covid vaccinations. Pfizer research found that their upgraded omicron BA.1 booster increases neutralizing antibody titers against the BA.1 virus 1.56 times more than the initial vaccination booster.
Under a purchase deal that reached the epidemic’s height, the federal government has been paying a negotiated price of $15 to $19.50 per dosage of mRNA vaccine. When those government agreements expire, analysts predict that the price of updated annual covid boosters would treble or double, if not more, as Moderna’s CEO said. A lot less commotion and a lot more knowledge could help deploy these bullets and funds effectively.
Pfizer and Moderna are just getting started in human studies with their upgraded omicron BA.5 boosters. Even though the revised omicron BA.5 boosters were only studied in mice, the FDA’s approval is consistent with precedent: the FDA approves updated flu vaccinations for new strains yearly without requiring human testing.
With flu vaccinations, however, scientists have decades of experience and a better knowledge of how increases in neutralizing antibody titers correlate with advances in vaccine efficacy. That is not the case with covid vaccinations. And if rodent findings were a strong predictor of clinical success, we’d have an HIV vaccine by now.
The Henry J. Kaiser Family Foundation permit this story to be reproduce from khn.org. The Kaiser Family Foundation, a nonpartisan health care policy research organization unconnected with Kaiser Permanente, sponsors Kaiser Health News, an editorially independent news service.
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