The Food and Drug Administration on Tuesday approved Novavax’s updated Covid-19 vaccine, giving Americans looking to upgrade their coverage against the SARS-CoV-2 virus another option.
While the FDA’s green light came three weeks after the approval of the updated Moderna and Pfizer-BioNTech vaccines, it contained good news for the Gaithersburg, Maryland-based company, which has struggled to claim a shrinking percentage of the Covid vaccine market. . – globally and in the United States.
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Previous regulations established by the FDA and the Centers for Disease Control and Prevention limited the use of this vaccine to people over the age of 12 who had not received a first Covid vaccine or who had received a first series and a single booster. and who would. There is no agreement to get more messenger RNA boosters, the generation used by Pfizer and Moderna.
While the age restriction remains in place, the other restrictions have now been lifted, making the Novavax vaccine available to anyone who needs to use it, provided it has been at least two months since their last Covid vaccine.
“Today’s authorization provides an additional Covid-19 vaccine option that meets the FDA’s mandatory safety, efficacy and production quality criteria to aid emergency use authorization. As we approach the fall season and transition to 2024, we strongly inspire those who are eligible to receive an updated Covid-19 vaccine to provide greater coverage against variants circulating lately,” Peter Marks, director of the Center for Biologics Evaluation and Research, said in a statement.
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In one move, the CDC’s specialized vaccine panel, the Advisory Committee on Immunization Practices, has already evaluated the vaccine and recommended at a Sept. 12 meeting that all Covid boosters that the FDA approves or authorizes be used in the United States. CDC Director Mandy Cohen agreed with this recommendation, which means that FDA approval opens the door for Novavax’s vaccine to be available without delay in pharmacies and doctors’ offices.
“The approval of Novavax today means that other people will now have the option to choose a protein-based option without mRNA to help protect against Covid-19, which is now the fourth leading cause of death in the United States,” John said. Jacobs, president and chief executive officer of Novavax, said in a statement, “In the coming days, Americans in the United States will be able to stop at primary pharmacies, doctors’ offices, clinics and government entities to obtain an updated Novavax vaccine. “
The company said it expects the vaccine to be available at thousands of locations across the country, adding CVS and Rite Aid pharmacies. The locations that store the vaccine can be found on the Vaccines. Gov online page or on the Novavax online page.
In clinical trials, the most common side effects related to the Novavax vaccine included headache, nausea or vomiting, muscle aches, joint pain, tenderness at the injection site, pain at the injection site, fatigue, and malaise.
Like the Moderna and Pfizer vaccines, the Novavax vaccine is monovalent and protective against a single strain of SARS-2. Although the virus has evolved since the FDA approved the vaccine strain in June, those vaccines are expected to offer counter coverage. to serious illness and death caused by Covid.
Novavax, which did not have its own means of production when it began its search to manufacture a vaccine against Covid, has struggled to compete with other more established or agile manufacturers. Among other problems, their vaccine, which uses a subunit protein platform, takes longer to manufacture and update than mRNA vaccines. This will remain a challenge as SARS-2 continues to evolve and vaccine targets are replaced in an attempt to keep pace.
Novavax’s solvency depends exclusively on the advertising success of its updated vaccine. Due to repeated delays in development and production, the company has not yet met peak demand for Covid vaccines and warned its shareholders that it may not do so in the next 12 years. months if sales do not resume.
The company’s stock is up about 12% on Tuesday’s news, and the FDA approval suggests Novavax could still play a role in the fall recall campaign.
Damian Garde contributed to the report.
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