WASHINGTON – The government Biden continues with a plan at least every 65 years and older – and possibly some young adults – to give the option of a second booster of Pfizer BioNTech- or Moderna coronavirus vaccine without outright to recommending that they get one, according to several people familiar with the plan.
Large uncertainties complicated the decision, including how long the protection would last for a second booster, how the plan should be explained to the public, even if the overall goal is to get everyone into consideration only will protect against serious diseases or for less serious infections as well, because they can lead to prolonged Covid.
Much depends on when will strike next wave of Covid infections, and how hard. Should the country be taken over the coming months by a powerful wave, then offering a second booster would now demonstrably older Americans could save thousands of lives and tens of thousands of hospitalizations may occur.
But if there are no major wave impacts until the fall, extra shots could turn out now on a questionable intervention waste doses of vaccine and vaccination fatigue could deepen and raise doubts about the government strategy. The highly contagious Omicron-subvariant BA.2 creates a new wave of cases of coronavirus in Europe and is responsible for around a third of new cases in the United States, but health officials said they expect no major increase caused by the subvariant.
Federal health officials have hotly debated the way forward, with some now strongly in favor of a second booster and others skeptical. But they seem together to work on a plan to give the option to older Americans anyway, just in case the infection for the autumn increase. It was not clear how wide would be the group. In the fall, officials say, would Americans of all ages still have a chance.
A decision by the Food and Drug Administration on whether to authorize a second booster may be, according to several people beginning next week who are familiar with the deliberations. The Centers for Disease Control and Prevention can then advise those who qualify to take another injection, rather recommended to do so.
Some people would at best be a stopgap measure the possibility of a second booster. Many experts assert that need to be adjusted because the variants of the virus reduce their power existing coronavirus vaccines; the question is how to configure them again. A peak is considered most likely in the fall, whether in the form of Omicron variant, such as a sub-variant BA.2 or an entirely new lineage.
There are more than a dozen studies underway to find the next generation of vaccines, and the first results are expected in May or June. If all goes well, that would give sufficient time to produce the new autumn doses. A major problem is that the government Biden says they do not have the money they need to pay in advance its place in the queue to book by vaccine manufacturers doses.
Positive aspect is that data from the CDC indicate that four to five months after a third injection of the Pfizer and BioNTech- Moderna vaccines for about 78 percent remain effective against hospitalization due to Covid-19. That may even be an underestimate, because the study possible included a disproportionate number of people with immune deficiencies, making them more likely to become seriously ill.
On the other hand, is 78 percent is still a decrease in the effectiveness of 91 percent which was found after two months, and the potency of the vaccines may be decreased further with more time. If in May or the summer strikes a new wave, even a somewhat modest decrease in protection against hospitalization have a huge impact on the had about 55 million Americans aged 65 or older, those most affected by the pandemic. Pfizer and Biontech said that emerging data, including Kaiser Permanente, demonstrate the potential of the booster dose against serious diseases decreases within three to six months.
According to data from the CDC is already one in 75 Americans aged 65 or older deceased to Covid, accounting for three-quarters of the deaths in the country by the virus. More than 33 million people received in that age group, or more than two-thirds have a first booster and would be eligible for a second.
For some officers, the key question this: how should decrease the effectiveness against hospitalization before a second booster is justified for those who are most at risk?
As in the autumn, when the boosters were rolled out, the wider scientific community is divided on the policy. “I’m not convinced that the protection decreases significantly against major diseases after the third dose,” said Dr. Philip Krause, a former senior supervisor at the FDA, in an interview.
dr. Monica Gandhi, a doctor of infectious diseases and medical professor at the University of California, San Francisco, said that healthy young people were okay one booster at this time, but that older people “probably now should get fourth injections.”
There is perhaps less resistance among scientists than there was at the first booster shots since there are indications that those doses lives saved during the Omicron wave of winter.
Given the limited nature of the data that support a second round of booster shots, some federal officials say that a kind of neutral advice the Biden administration can go. But overall is weak advice on regulations not popular because people and doctors often want more specific advice than options.
dr. Judith A. Aberg, head of the department of infectious diseases at the Mount Sinai Health System, said that might be frustrated with the public only permission for a second booster.
Unlike the first round of regulatory decisions on booster shots, there are no meetings of the advisory committees of the FDA and the CDC plan before deciding on second boosters. The panel recommendations are not binding, but are generally followed. Bypassing these committees will bring criticism.
“This is a complex decision that a pretty deep dive entails, and I think it would really benefit from a public debate,” said Dr. Jesse L. Goodman, a former chief scientist at the FDA. “I would like to see no advisory about beaten at this point.”
But government officials seem willing to accept complaints about the process. The FDA has scheduled an April 6 meeting of its Advisory Committee to discuss what should be the overall strategy of vaccine administration.
As for the timing, federal officials seem to just make their best guess. When people are given a second booster and the virus revived in July, their protection may have disappeared again. On the other hand, if the administration is waiting to strike a Covid golf, will be too late to vaccinate millions of people.
The stock is there, at least for the elderly: states have 131 million doses of the Pfizer BioNTech- and Moderna vaccines on hand.
Many experts say there is no evidence that an additional injection could damage the immunity of people to get them used to coronavirus vaccines.
The biggest drawback is perhaps more vaccine fatigue and skepticism that the vaccine works and that the vaccine policy of the country is really driven by data. With each subsequent recording becomes available, get fewer Americans. On the other hand authorizing a second booster can cause more people first, said Dr. Aberg of Mount Sinai.
Besides the CDC Britain and Israel published data on the declining effectiveness of booster shots. The latest report by the UK Health Service states that the efficacy against symptomatic infection drops to 25 to 40 percent, 15 weeks or more after a booster dose of Pfizer or Moderna.
But the British health service said how good boosters protect against hospitalization was difficult to measure. Because Omicron usually a milder disease caused than previous versions, more hospitalized patients tested positive for Covid, but they were taken for other reasons.
Just looking at patients admitted for respiratory disease, the agency estimated that the vaccine efficacy against hospitalization for people over 65 dropped to 85 percent, 91 percent or 15 weeks after the booster. Like a few other countries, the UK offers this spring a second booster to the elderly and others at high risk.
Data from Israel suggest that a second booster injection, the four-fold increases protection against hospitalization, and two-fold against infection. But no one knows for how long. Since Israel only recently started its second booster campaign, it has information of only two months or less. Other Israeli data suggests that a second booster restores antibody levels to their peak level after the first booster, but Dr. Aberg said that dataset also had limitations.
Neither Pfizer nor Moderna seem to dispose of many of their own data to their requests for support to emergency authorization; Pfizer is seeking second boosters for 65, while Moderna submitted a drastic request to provide second booster shots to all adults. Neither has submitted data from a randomized, placebo-controlled trial – considered the gold standard of scientific evidence – how well the dose would work.
“We have to make this decision based on incomplete information,” said Dr. Peter J. Hotez, a vaccine expert at the Baylor College of Medicine in Houston.
Sheelagh McNeill and Kitty Bennett research contributed.