Scientists from the Food and Drug Administration concluded that a vaccine that might entice people who are hesitant about getting vaccinated against COVID-19 is highly effective in documents released Friday.
According to the FDA, Novavax, Inc. of Gaithersburg, Md., found that the vaccine was 90% effective in preventing mild, medium and severe COVID-19. The vaccine was tested on approximately 30,000 people aged 18 and over.
However, FDA scientists said that a few cases of rare heart inflammation in vaccine recipients was “concerning”. This condition has also been rare in patients who have received COVID-19 vaccines. Novavax stated that there is not enough evidence to prove a causal link between the vaccine and these cases.
The FDA’s Tuesday adviser meeting was scheduled to discuss whether the FDA should recommend the approval of the vaccine.
This vaccine requires two shots, spaced 21 days apart. It could be appealing to people who have not been vaccinated.
These vaccines stimulate the immune systems by injecting genetic code from the SARS/CoV2 virus into your body. They are extremely safe and effective but some people hesitate to use them due to misinformation and new technology.
“We all know there are some people in the population that are still concerned about a vaccination that is relatively new within the field of vaccinology,” Dr. Anthony Fauci, White House science adviser, said to NPR in an interview. They may be looking for a classic vaccine, which we have many years of experience with.
Novavax uses a method that has been used in many other vaccines. This involves injecting the virus’ protein, which is made from insect cells. To stimulate the immune system further, the protein is then combined with an adjuvant.
In an interview with NPR, Dr. Gregory Glenn, president of Novavax’s research and training, stated that “it’s a very efficient and proven way to create vaccines.”
Others are skeptical that the Novavax vaccine would convince those who aren’t ready to get vaccinated.
Saad Omer, a Yale University student who studies vaccines, says, “I’m still not sure that I believe in that, unfortunately.” “It’s not as if there are a lot of people who just want to get vaccinated. “I don’t believe so.”
The vaccine’s effectiveness against the omicron variant is a key question. It wasn’t available at the time the vaccine was tested. However, FDA scientists believe it will prove useful.
FDA staff stated that “based on the efficacy estimate from the clinical trial, it is more probable than not that the vaccine would provide some meaningful degree of protection against COVID-19 because of Omicron in particular against more serious disease.”
Novavax is currently studying this question as well as a new vaccine specifically targeting omicron. Novavax is also testing its vaccine’s effectiveness as a booster for people who have received the mRNA vaccines.
Federal officials are trying to determine what type of booster people should receive in fall to reduce the severity of possible new infections next winter. A panel of FDA advisors will meet in the last week of October to discuss which coronavirus strains should be targeted with updated vaccines.