The US Food and Drug Administration (FDA) has delayed the approval of Novavax’s COVID-19 booster vaccine, citing a need for additional clinical data. However, patients with long COVID and other groups who rely on the vaccine are fighting to keep it on the market.
Novavax is the only COVID-19 booster that does not use messenger RNA technology, which some states have begun to ban. The FDA has given the company an opportunity to provide more clinical data on its efficacy following approval.
Vaccine critic Robert F. Kennedy Jr. recently criticized Novavax, stating that single-antigen vaccines are ineffective for respiratory illnesses. However, vaccine experts argue that many examples of effective single-antigen vaccines against respiratory illnesses exist.
Patients with long COVID rely heavily on COVID boosters to avoid reinfections with the virus, which can cause their symptoms to flare. The FDA’s delay has left these individuals without a means of protecting themselves.
A small study by Yale immunobiologist Dr. Akiko Iwasaki found that patients with long COVID fared well with an mRNA booster, but 3 out of 16 volunteers experienced worsening symptoms. Iwasaki suspects that Novavax may be easier to use for patients with long COVID due to its lower reactogenicity.
As the current batch of Novavax boosters expires on April 30, many are scrambling to find last doses ahead of a potential summer wave of COVID-19 cases. Patients and advocacy groups continue to push for FDA approval, citing the need for access to this vital vaccine.
Source: https://www.reuters.com/business/healthcare-pharmaceuticals/fda-delays-novavax-covid-vaccine-approval-patients-fight-back-2025-04-24