The coronavirus vaccine should be renewed for the fall, FDA advisers say

As companies take months to produce new vaccines, the deadline for choosing a vaccine prescription ready for deployment in October has come. The FDA is expected to make a final decision within a few days.

Coronavirus vaccine tracking

However, no one knows what variants will be prevalent this winter. It is reasonable to expect that the Omicron variants incorporated into the updated vaccine will enter the rear-view mirror by the time the shot becomes a weapon. Updated vaccine Those containing BA.1 have been tested by humans for months, but the variant has been prevalent this winter and has already been concealed by other versions of Omicron.Subvariants BA.4 and BA.5 are already configured Half of the case In the United States.

There is also uncertainty as to whether the renewed vaccine really protects people better. Companies have shown that they can trigger moderately high levels of virus blocking antibodies, but it is unclear if that will lead to better protection against hospitalization and infection. The improved vaccine is expected to broaden the immune response.

“Today we are more or less required to have a crystal ball,” said Arnold Monto, chair of the FDA Advisory Board and Professor Emeritus of Public Health at the University of Michigan School of Public Health. rice field.

During the discussion, many members of the committee stated that the vaccine should be a multi-strain vaccine containing the original version of the virus and the components of Omicron. Many members and FDA authorities supported the BA.4 and BA.5 Omicron subvariants, but others were hoping to include the BA.1 version of Omicron.

“Given the speed of evolution, [of the virus] Mark Sawyer, a professor of clinical pediatrics at the University of California, San Diego School of Medicine, said: “The general perception is that the FDA has already postponed approval. I think that enough data is presented here today to drive the strain change.”

Vaccine companies, including Moderna, NovavaxPfizer and its German partner BioNTech present sometimes conflicting data on potential booster strategies, forcing committee members to duplicate and sometimes triangulate between different results. I did.

Paul Offit, a vaccine expert at the Philadelphia Children’s Hospital, called the data “unpleasantly scarce” and voted against the strain change. He questioned whether the slight differences in how modified vaccines elicit an immune response are significant enough to benefit people.

“I don’t think it’s fair to ask people to take risks … if we’re not happy with the level of protection we might get,” Offit said.

Each company presented data to support its priority strategy.

For example, Moderna Bivalent vaccine It has been tuned to protect against the original version of the virus and the Omicron BA.1 variant. The company said it could start vaccination this summer, but warned that vaccines containing BA.4 and BA.5 could be vaccinated until late October or early November.

However, Pfizer and its German partner BioNTech have found that vaccines targeting BA.1, a single variant of the virus, are superior to divalent formulations. The company also said that vaccines tailored to fight the soon-to-be-dominated Omicron subvariants, BA.4 and BA.5 in the United States, could elicit a stronger and broader immune response. We have presented suggested mouse data. The company is ready to supply either version of the vaccine by the first week of October.

The Novavax vaccine is not yet licensed in the United States, but uses a different technique — Delivery of viral proteins Brewed in the laboratory. The company provided data suggesting that additional doses of existing vaccines may be protective even against subvariants of Omicron. Clinical trials of the Omicron booster are underway and results are expected in September.

Adam Berger, director of the Clinical and Healthcare Research Policy Division of the National Institutes of Health, suggests that the data presented at the conference favor a universal recommendation to change vaccines for simplicity, but the results are ” It’s not a universal answer as to whether strain changes are needed. “

Some experts have raised concerns that if the United States changes the composition of the vaccine, it could be exacerbated. Global Vaccine Fairness Issues And vaccine recognition. It was also unclear whether the vaccine change would apply to adults or include children. Some experts said they would like to see more tests if the vaccine was changed for the child.

However, during public comment sessions, some parents enthusiastically pleaded that the vaccine would be updated for all age groups, including the youngest child.

Wait for the vaccine for the child Kate Schenck, the mother of three children, said that under the age of five was “long and intolerable.” She said, “This can never happen again. Children must be eligible to receive these updated boosters with their old cohort — not late and unprotected.”

What you need to know about coronavirus vaccines for children under 5 years old

Peter Markes, director of the FDA’s Center for Biologics Evaluation and Research, has half of Americans I haven’t received a boosterDespite clear evidence that the third shot will recover and extend protection. Even those who receive boosters become vulnerable again over time as their immunity weakens.

“We believe that the more compatible the vaccine is with the circulating strain, the more effective the vaccine will be and the more durable the defense will be,” says Marks.

However, even updated vaccines do not reset the pandemic, evolve rapidly, and provide complete protection against highly infectious viruses. The Omicron subvariants, which are already increasing in frequency today, may not be what the world faces in the fall. How well the vaccines based on them are protected from future repeats of the virus is not entirely known until they are used.

This process is compared to getting the flu vaccine each year. In one year, it matches better with circulating influenza strains than others.

However, influenza is another virus, and this conference is an early stage in the long-term challenge of developing a vaccination strategy.

“Remind us that parallel tracking of a very well-performing influenza strain selection has been a well-honed process for many years, so it probably requires a lot of work,” said the Vaccine Research Review Bureau. Jerry Weir, Head of Virus Products Division, said. “This is another virus. There is a lot to do about the strain selection process for the corona vaccine.”