The Covid-19 vaccine made by Novavax is an early beneficiary of the government's Operation Warp Speed program.
The experts to the FDA will base their recommendation on the company's clinical trial data. The F.D.A. needs to sign off on Novavax's manufacturing process before the shots can be given.
If the F.D.A. approves the Novavax two-dose vaccine, it will be the fourth shot to get clearance for adults in the US. Even if the company gets the go-ahead, it's not clear when or how much the vaccine will be available. Over the course of a year, shots from Pfizer- BioNTech, Moderna and Johnson & Johnson have been authorized. In a number of countries where Novavax has already been approved, it has not been very popular.
A spokesman for the Department of Health and Human Services said in an email that the federal government is coordinating with Novavax to get a limited amount of vaccine. We are committed to making sure that any American who wants a vaccine can get one. Pfizer-bioNTech and Moderna have shots made with the same substance.
The Novavax vaccine is different from the three authorized shots in that it contains particles from the coronaviruses.
The Novavax vaccine was shown to have an efficacy of 90.4 percent in clinical trials. The volunteers who received the vaccine did not experience moderate or severe infections.
The Delta and Omicron variant have evaded some of the immunity from other vaccines.
Six cases of myocarditis and pericarditis were identified in about 40,000 trial volunteers.
The F.D.A. documents stated that the events raised the concern for a causality with the vaccine.
Novavax believes there is not enough evidence to establish a relationship. Myocarditis and pericarditis will be monitored.
Moderna and Pfizer-BioNTech did not find any cases of myocarditis or pericarditis. The vaccines were found to increase the risk of myocarditis in boys and young men.
The European Union and World Health Organization have given the go-ahead for the Novavax vaccine in many countries.
The number of vaccines distributed around the world and the number of people who are receiving them are both below expectations. Covax is a United Nations program that gives shots to developing countries. Covax has not yet ordered any Novavax drugs.
In other countries, demand for the vaccine seems to be low. Novavax has shipped 42 million doses to 41 countries. According to the F.D.A., Australia, Canada, the European Union, New Zealand, and South Korea give information on how many people have received the vaccine. The total in these countries was less than a million dollars.
Novavax didn't give a total number of doses administered in other countries.
The United States agreed to buy more than 100 million doses of the vaccine if it was given the green light. The government has little need for more because the country already has an effective vaccine.
Novavax was slow to demonstrate that its process met F.D.A. standards because it had trouble scaling up production. The Serum Institute of India, the world's largest vaccine producer, is now manufacturing Novavax's vaccine and would be the supplier of any doses sold in the US.
Testing and submission of manufacturing data on the vaccine were still in progress when the F.D.A. reviewed it.
Stanley Erck, the chief executive of Novavax, said in an interview that the company is in talks with the government about how many doses it will give. He said that there would be several million doses coming into the US within weeks.
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