With J&J Vaccine Restrictions, Experts Say We Need More Options Beyond mRNA

Johnson & Johnson COVID-19 vaccines are now limited to only a select group of people, according to an announcement made by the Food and Drug Administration (FDA). The vaccine is now only authorized for people 18 and over whom Pfizer and Moderna vaccines are not accessible or clinically appropriate and to those who would not get a COVID-19 vaccine otherwise.

The FDA said the restriction was due to the risk of a rare and life-threatening blood clot called thrombosis with thrombocytopenia syndrome (TTS) after receiving the vaccine.

However, the agency said people who had a severe allergic reaction to an mRNA vaccine or personal concerns about the mRNA vaccine may still get a J&J shot. With the new limits placed on J&J, experts say it's important for the FDA to authorize other COVID-19 vaccines like Novavax and Sanofi/GSK to offer more options beyond mRNA.

According to a phase 2 clinical trial by the National Institutes of Health, researchers found rare cases of severe allergic reactions to the two mRNA vaccines, mainly in people with a history of allergies and anaphylaxis, and among those with certain blood disorders. 

“These cases are rare, and research shows that the majority of them are mild, treatable, and triggered not by the mRNA, but other ingredients added as stabilizing agents,” said Bernadette Boden-Albala, DrPh, MPH, director and founding dean at the University of California, Irvine Program in Public Health.

More Vaccine Options Are Needed

Boden-Albala said the recent restrictions on the J&J vaccine call for a more speedy authorization of Novavax and Sanofi/GSK, two non-mRNA vaccine candidates.

Both Novavax and Sanofi/GSK have recently requested emergency use authorization of their COVID-19 vaccine. They are both protein-based vaccines, which are similar to vaccines used to protect against the flu and those used in routine childhood vaccinations like those that protect against meningococcal infection, Boden-Albala said.

She explained these vaccines also contain purified pieces of the spike proteins found in the virus that causes COVID-19, which are delivered along with an adjuvant, an ingredient that boosts the immune response by keeping antigens at the injection sites for longer periods.

“We’re still learning more about the Novavax and Sanofi/GSK vaccines, but early research suggests that it may have some advantages over existing COVID-19 vaccines in some cases,” Boden-Albala said. “One distinct advantage is its ability to be more easily stored and transported than its viral vector and mRNA counterparts since it can be stored in standard vaccine fridges.” 

It is important to have different vaccine options, especially for people who cannot have the mRNA vaccine due to medical reasons like allergies or for those who struggle with access, said Niket Sonpal, MD, an adjunct professor of clinical medicine at the Touro College of Osteopathic Medicine in Harlem.

Having different vaccine options can also be beneficial for people who may have vaccine distrust toward certain vaccines, Sonpal added.

“There’s a lot of misinformation across the Internet, so it’s always good to have an alternative,” Sonpal said. “But again, there are side effects with everything, though rare, it is important for the population to know about it.”

Boden-Albala said expanding access to mRNA vaccines and other vaccine options nationwide can potentially reach more people to help prevent the risk of infection and severe disease.

“The risks associated with COVID-19 infection are vast and can be severe—often much more so than any of the known or potential risks of the vaccines—so we need to prevent disease as much as possible,” Boden-Albala said. “Providing options is one way to do that.”

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