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A vaccine that could tempt some people who were hesitant to get vaccinated against COVID-19 seems safe and effective, Food and Drug Administration scientists concluded in a document released Friday.
Gaithersburg, Md. Of Novavax, Inc. The vaccine produced by did not cause any serious side effects and was tested in a study of about 30,000 volunteers aged 18 and older, about 90% effective in preventing mild, moderate and severe COVID-19, according to the FDA.
The assessment was released ahead of Tuesday’s meeting of FDA advisers on whether the agency would recommend approving the vaccine.
The vaccine, which requires two shots at 21-day intervals, may apply to some people who have not been vaccinated because it uses a more traditional method than the mRNA vaccines developed by Moderna and Pfizer-BioNTech.
These vaccines stimulate the immune system by injecting genetic code for a key protein from the SARS-CoV2 virus into the body. Although they are very safe and highly effective, some people are reluctant to use them because the technology is new and there is misinformation about their safety.
“We all know that there are some people in the population who are still concerned about a vaccine that is relatively new to vaccineology,” said Dr. Anthony Fawcett, a White House science adviser. “And they may want more classical vaccines with which we have years of experience.”
The Novavax vaccine uses a method that has been used for many other vaccines. This involves injecting a protein from the virus that is produced for the vaccine by insect cells. The protein is then combined with a substance known as a stimulant to further stimulate the immune system.
“This is a very effective and proven way to make a vaccine,” Dr. Gregory Glenn, president of research and training at NovaVax, told NPR in an interview.
But others are skeptical that those who are reluctant to get the vaccine will be affected by the Novavax vaccine.
“Unfortunately, I’m not sure I bought it,” said Saad Omar, who studied vaccine at Yale University. “It’s not like a huge chunk of people are waiting for something other than the mRNA vaccine and just be vaccinated. I don’t think so.”
A key question is how well the vaccine will work against the Omicron variant, which was not promoted during the testing of the vaccine. But FDA scientists doubt it will work.
“Based on estimates of the effectiveness of clinical trials of this vaccine, it is unlikely that the vaccine will provide some significant level of protection against COVID-19 due to omecran, especially against more serious diseases,” FDA staff wrote.
The agency is currently evaluating that question, as well as a new version of the vaccine specifically targeting Omicron. Novavax is also testing how well its vaccine works for people who have been vaccinated with two shots of the Novavax vaccine as well as the mRNA vaccine.
The federal government is trying to determine what kind of booster should be available in the fall to blunt the intensity of possible new wave of infections next winter. A panel of FDA advisers will meet later this month to consider which strains of coronavirus should be targeted by the updated vaccine.