This week, the number of reported COVID-19 infections surged in the US and many corners of the world, thanks in large part to the rapid spread of the Delta variant. At the same time, the FDA has continued to keep its eye on developments related to the virus, and issue authorizations and advice where appropriate.
The FDA amended the emergency use authorizations (EUAs) for two of the three vaccines under such authorizations (the Pfizer-BioNTech vaccine, and the Moderna vaccine) to allow for a booster shot in certain immunocompromised individuals. The to-date authorized group includes organ transplant recipients and patients diagnosed with conditions considered to possess an equivalent level of immunecompromise.
“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease," said acting FDA commissioner Janet Woodcock. “After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna vaccines.”
The Center for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices reportedly plans to assemble on Friday to consider further clinical recommendations for immunocompromised patients. This week’s action does not apply to non-immunocompromised people, although as Woodcock pointed out, the federal government could recommend a booster for such citizens in the future.
“As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time,” Woodcock remarked. “The FDA is actively engaged in a science-based, rigorous process with our federal partners to consider whether an additional dose may be needed in the future.”
The FDA evaluated information on the use of a third dose of the two vaccines in immunocompromised individuals and determined that the administration of third vaccine doses may increase protection in those populations. Additionally, the agency recommends such patients continue to take masking and social-distancing precautions, and that their close contacts should get vaccinated.
Teens and parents
With many questions circulating about the vaccination of young children and adolescents, the FDA launched an information page and video “5 Things You Need to Know about the COVID-19 Vaccine for Adolescents 12 through 17" geared toward children and parents. The resource is designed to answer queries about the safety of the vaccination, at what age the vaccine has been determined to be safe for the patient and to correct misinformation.
The resource contains a frequently asked questions (FAQ) list, addressing the safety of the vaccine regarding younger Americans, potential side effects, FDA’s continued monitoring of vaccine development and validation, and more. The resource also refers visitors to other pages about up-to-date vaccine developments.
Stern warning letter
To date, the FDA has not approved or authorized any consumer products for the prevention, treatment, or cure of COVID. That lack of approval, however, has not stopped unscrupulous companies from attempting to make, distribute and sell such items.
A company named Secret of the Islands received a warning letter from Donald Ashley, director of the Office of Compliance of the Center for Drug Evaluation and Research (CDER) ordering the firm to stop making and selling its range of COVID-geared products and to cease hawking of the items on its website and social media accounts. The company’s fraudulent claims about its salt scrub products include website text purporting one product to be “the world’s first and only doctor-approved anti-bacterial and anti-viral salt scrub that kills/deactivates the coronavirus,” a claim that has not been checked and/or verified by the FDA.