When public health officials are expecting another wave of infections, the Food and Drug Administration's panel of independent vaccine experts voted 19 to 2 to recommend new Covid-19 shots that target the omicron variant.
The panel has never proposed that vaccine makers modify the shots to target a different variant. The FDA will likely approve the vaccine change. The panel didn't make a recommendation on which shot to use.
The original Covid strain of vaccine was developed by Pfizer, Moderna, Novavax and Johnson and Johnson. The vaccines have become less effective at protecting against infections due to the rapid evolution of the virus.
The vaccines are designed to stop the virus from invading humans. The shots can't recognize and attack the spike when it's different from the original version of the virus. The omicron variant has more than 30 genes. This is one of the main reasons why omicron caused such a large wave of infections last winter, even though so many people were fully vaccined.
Omicron is becoming more contagious. The U.S. faces a Covid outbreak this fall and winter as immunity from the vaccines fades, and people spend more time indoors where Covid spreads easier.
Marks told the committee that they needed to give serious consideration to a booster campaign. The better the match of the vaccine to the circulating strain, the more effective it may be.
The most optimistic projections from a team of scientists are that 95,000 additional people could die from Covid by March 2023. There is a chance that 211,000 people will die from the virus by March of next year. There is a lot of uncertainty in the projections.
According to data presented by the Centers for Disease Control and Prevention, three doses of the current vaccines are only effective at preventing infections from omicron among adults ages 18 and older. The more contagious BA.2 and BA.2.12.1 subvariants are likely to be the reason for the low protection against infections. The data shows that a third dose was effective at preventing hospitalization for 120 days or more.
The vaccine companies are having a hard time keeping up. The original version of BA.1 was developed by Pfizer and Moderna. BA.1 is no longer present in the U.S. Marks said that the omicron subvariants are poised to become dominant in the U.S.
The data was presented by Pfizer and Moderna based on small studies of several hundred people. The immune response was still strong despite the fact that the updated shots did not perform as well as they could have. The strength of the immune response is an indication of how much protection the shots will provide against illness, but there is no data on the effectiveness of the updated shots.
The committee member said it was unclear whether the data would translate into protection in the real world.
The data presented at the meeting was "uncomfortably scant" according to Offit, an infectious disease expert at Children's Hospital Philadelphia.
The FDA panel members agreed that it would be better to target omicron BA.4 or BA.5 rather than the BA.1 variant. Logistical challenges for the vaccine companies could be created by this.
Data presented by Novavax showed that a booster dose of its current vaccine produced a strong immune response. The FDA official said the Novavax data hasn't been independently verified.
There isn't enough safety data on how changing the vaccines' composition might affect heart inflammation, or myocarditis, according to a panel member. Pfizer and Moderna's current shots have been linked to an increased risk of myocarditis in adolescents.
There needs to be more research into the relationship between vaccines and myocarditis.
Marks said that it is important to make a decision on whether or not to update the vaccines very soon so that the manufacturers have time to make the shots. Congress has not appropriated money to purchase more vaccines. The White House warns that the U.S. may have to ration shots in the fall for people at high risk.
The U.S. Covid response has said that other countries have begun negotiations with vaccine makers for new shots. As the administration waits for more money from Congress, it has carved out $5 billion in funding to start talks with companies. The $5 billion the White House is using for vaccines was originally intended for Covid tests and protective equipment, which means there is less money for those other important tools to fight the Pandemic.
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