If You Got This COVID Vaccine, the FDA Says to Get a Booster Right Away
An FDA panel has just made new recommendations on booster doses.
Over the past few months, health officials and experts have battled over whether or not to provide booster shots, as all three vaccines still appeared to protect most people against severe COVID. In late September, both the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) nevertheless decided to go ahead and authorize Pfizer boosters for select groups of people. Now, an advisory committee for the FDA has endorsed booster shots for Moderna and Johnson & Johnson as well. But for the recipients of one of these vaccines, there might be more urgency when it comes to getting another dose.
On Oct. 15, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to endorse authorizing a booster dose of Johnson & Johnson to all recipients of the one-shot vaccine, per The New York Times. In a 19-0 vote, the agency recommended that recipients of this vaccine receive a second shot at least two months after the first dose.
This strays from the panel's recommendations for Pfizer and Moderna, as the VRBPAC only endorsed boosters of these two vaccines for certain recipients: those 65 years and older and those younger who are at higher risk due to medical, occupational, or institutional reasons. The timeline is also accelerated for Johnson & Johnson recipients, who can get another shot after two months instead of the six months recommended for Pfizer and Moderna boosters. The FDA does not have to follow the panel's advice, but it usually does.
Many of the panel members noted that they viewed the Johnson & Johnson booster as more of a second shot, like Moderna and Pfizer already have, rather than a booster on par with the mRNA vaccines. "I certainly agree with my colleagues that this does look more like a two-dose vaccine," VRBPAC member Michael Nelson, MD, said, per CNBC.
Amanda Cohn, MD, an official from the CDC, added to the committee that, "The effectiveness or protection of a single dose of the J&J vaccine is not equivalent to protection at this time with either two doses of an mRNA vaccine and certainly not in those groups who have now been authorized to receive a booster dose of an mRNA vaccine," per CNN. According to Cohn, various studies suggest that real-world efficacy of Johnson & Johnson's one-shot is only around 50 to 68 percent against both infection and hospitalization.
The committee's decision was also made despite Johnson & Johnson's actual data on its booster shots being "a little bit immature and somewhat scant in multiple areas," Nelson said. The vaccine manufacturer only presented data based on a group of 17 volunteers given boosters six months after first shots and a larger study of 51 trial participants who were given a booster two months after the first dose, according to CNBC.
Johnson & Johnson said that an extra dose administered two to six months after the first dose boosted protection against symptomatic infection to 94 percent. Johan Van Hoof, MD, a vaccine development executive for Johnson & Johnson, told the FDA committee that boosters administered six months after the primary dose resulted in a 12-fold increase in antibodies, while there was a 5-fold increase in antibodies from the larger study following boosters given after two months.
But committee chair Arnold Monto said that the data was clear in that Johnson & Johnson's one-shot vaccine has a lower level of protection against infection and severe COVID when compared to Pfizer and Moderna's vaccine. According to new data released from the CDC, Johnson & Johnson has been the least protective vaccine against both COVID cases and deaths. Fewer than one in every 100,000 people vaccinated with either Moderna or Pfizer have died from COVID, while Johnson & Johnson's death rate is nearly twice that.
"There is a public health imperative here because what we're seeing is this is a group with overall lower efficacy than we have seen with the mRNA vaccines. So there is some urgency to do something," Monto said, per CNBC.