Last month, the FDA approved the omicron-specific vaccine, accompanied by a stifling scientific press release and media hype. Just days after the FDA’s action, the Centers for Disease Control and Prevention followed suit, recommending updated boosters for people 12 and older who have received at least two doses of the original Covid-19 vaccine. A message to a country still battling the covid-19 pandemic: The cavalry – in the form of shooting – is over the mountains.
But for those familiar with the business strategies of the pharmaceutical industry, this exuberant messaging – coupled with a lack of complete research – has caused considerable heartburn and sparked a Series of unresolved issues.
Updated footage easily clears the government mandated “safe and effective” threshold. But in the real world, are omicron-specific vaccines more protective than the original covid vaccine many people already take Sex – and in what ways? If so, who will benefit the most from the new lenses? Since the federal government is buying these new vaccines — and many of the original, already-purchased vaccines may never make it to taxpayers — is the $3.2 billion price tag worth the ill-defined benefit? Especially when those funds have to be withdrawn from other coronavirus response efforts such as testing and treatment. Said she only voted “reluctantly”.
Some said they gave up their desire for more information and better data and voted yes because of fears of a potential winter coronavirus surge. They expressed hope that the new vaccine — or at least the vaccination campaign that accompanies it — will reduce future cases, hospitalizations and deaths. , which is understandable given the average daily death of more than 300 Americans from the coronavirus.
But this puts front-line healthcare providers in an impossible position to try to advise individual patients if and when to take a hot new vaccine without full data and marketing hype.
Don’t get us wrong. We are grateful and amazed that Pfizer-BioNTech and Moderna (with assistance from the National Institutes of Health and Operation Warp Speed) have developed an effective vaccine in record time, lifting the nation out of the deadliest of the coronavirus pandemic The stage when thousands of people were dying every day. The pandemic isn’t over yet, but a vaccine is largely credited with returning much of the U.S. to normalcy. We are all up-to-date with our covid vaccinations and don’t understand why someone would choose not to and play Russian roulette with their health.
But as society moves into its next phase during the pandemic, the pharmaceutical industry may be entering more familiar territory: developing products that may be better than before, in the absence of adequate controlled studies or published data Selling under conditions—sometimes oversold—they boost effectiveness, advertising them as desirable for all when only a few can significantly benefit, and likely to raise prices later.
This last point is worrying because the government no longer has the money to buy a Covid-19 vaccine after this fall. Funds to pay for vaccinations and community outreach providers have run out. So now and in the future, updated boosters may be offered to “worried” people with good insurance, rather than those at highest risk of contracting and progressing to serious illness.
FDA’s mandate is solely to determine whether a new drug is safe and effective. However, before authorizing the updated omicron BA.5 booster, the FDA may ask Pfizer and Moderna to provide more clinical vaccine effectiveness data.
However, the FDA cannot weigh important follow-up questions: How much of the updated booster is more effective than the vaccine already on the market? In which population? What efficiency gains are enough to drive prices up (so-called cost-benefit analysis)? Other countries, such as the UK, conduct such analyses to negotiate fair national prices before allowing new drugs to market.
The updated booster vaccine formulation is the same as the original covid vaccine, except that the mRNA code is adjusted to match the omicron BA.5 virus. Pfizer’s study showed that its updated omicron BA.1 booster delivered a 1.56-fold increase in neutralizing antibody titers against the BA.1 virus compared to a booster with its original vaccine. Moderna’s study of its updated omicron BA.1 booster showed very similar results. However, others predicted that a 1.5-fold increase in antibody titers would only marginally improve vaccine effectiveness against symptomatic and severe disease by about 5% and 1%, respectively. Pfizer and Moderna have just started studying their updated omicron BA.5 booster in human trials.
While studies of the updated omicron BA.5 booster have only been conducted in mice, the agency’s authorization is consistent with precedent: FDA clears updated influenza vaccines for new strains each year, without human testing. But with flu vaccines, scientists have decades of experience and a better understanding of how increased neutralizing antibody titers correlate with improved vaccine effectiveness. This is not the case with the Covid-19 vaccine. If the mouse data is a good predictor of clinical effectiveness, we could now develop an HIV vaccine.
As herd immunity builds up through vaccination and infection, it is unclear whether additional vaccine boosters, updates or not, will benefit all ages equally. In 2022, the rate of COVID-19 hospitalizations for people 65 and older in the United States will increase relative to younger people. While coronavirus vaccine boosters appear to be cost-effective in older adults, they may not work in younger populations. The CDC’s Advisory Committee on Immunization Practices had considered limiting the updated booster to people 50 and older, but ultimately decided it was too complicated.
Unfortunately, history has shown – as with other medicines – that once a vaccine is available and accompanied by marketing, salesmanship trumps science: many people with money and insurance will demand it, no matter what The data ultimately proves necessary for them personally.
We are all likely to encounter the SARS-CoV-2 virus again and again, and the virus is constantly mutating, producing new variants year after year. Fears of a winter surge are justified in a country where a significant portion of the at-risk population remains unvaccinated and unvaccinated.
But the widespread adoption of a vaccine – in this case the annual update of the covid booster – is ultimately a boost to protection for those who really need it, or just an increase in drugmakers’ profit? Is it worth the money?
The federal government has been paying negotiated prices for mRNA vaccines ranging from $15 to $19.50 per dose, according to purchase agreements signed at the height of the pandemic. When those government deals lapse, analysts expect the price of the updated annual Covid booster to triple or quadruple, possibly even more, and Moderna’s CEO says it will grow “like the iPhone.” To deploy these lenses and these funds wisely, a lot less hype and a lot more information might help.