An FDA advisory panel endorsed the Johnson & Johnson booster shot for all adults on Friday; the final decision to approve the booster for general use now rests with the FDA itself.
The panel recommended that there be a 2-month gap in the shot series for all those 18 and over, meaning that there must be at least that amount of time since the end of the initial J & J shot and the booster.
The J & J inoculation is the only single-shot coronavirus vaccine that has been authorized in the United States.
The panel’s vote was unanimous, at 19-0.
The panel, known as the Vaccines and Related Biological Products Advisory Committee (VRBPAC), had been tasked with judging whether or not the safety and effectiveness data called for an emergency authorization for the booster shot.
The data they studied was from a trial involving 30,000 participants.
In a different scenario than has been put before the FDA panel in the past, the panel recommended shots for all adults; this marks the first recommendation for all those over 18 to receive a booster.
All previous decisions regarding coronavirus booster shots recommended that they be given only to those in certain high-risk groups.
Johnson & Johnson booster ups effectiveness to 94%
For the Pfizer-BioNTech and Moderna inoculations, boosters were only recommended for adults over age 65 and those aged 18-64 who were at high risk of exposure and severe Covid-19 complications.
According to Johnson & Johnson, the initial dose of their product was 74% effective against severe coronavirus and 70% protective against what they termed as “symptomatic,” or less severe, disease symptoms.
According to Dr. Penny Heaton, the global therapeutic division director at Janssen, the producer of the J & J product, a booster shot given two months after the initial one-dose coronavirus vaccine series increased protection to an extremely impressive 94%.
Overall, however, a number of studies showed a range of efficaciousness; according to a report from Fox News, surveillance data indicated that the Johnson & Johnson booster shot was 68% effective against hospitalization among adults who did not suffer from immunodeficiencies.
Perhaps most interestingly, Heaton said that the protection afforded by the initial J & J shot was quite lasting over time; this is in contrast to the Pfizer and other shots, which in testing have shown to become much less effective over time.
The Pfizer inoculation has shown itself to sink to 47% from a high of 88% six months after the second dose, according to data that U.S. health agencies considered when deciding on the need for booster shots.
This data, which was published in the medical journal The Lancet, had already been released in August, before the peer review that was part of the FDA’s booster approval process.
However, the mRNA-based vaccine’s effectiveness in preventing hospitalization and death stayed at an impressive 90% for at least six months, even against the highly contagious Delta variant, according to the data.
One wrinkle in the J & J product is that overall it gives less protection to its recipients compared to the mRNA-based shots, even taking their waning potency over time into consideration.
Panel member Dr. Michael Kurilla told J & J officials “The reality is that your vaccine does seem to be holding up actually quite well in terms of durability, so the immediate need for a booster is not apparent.” However, he added that there may be a benefit in administering it, considering the constant emergence of variants of the virus.
In an important caveat, panel members stated that the FDA has still not conducted either complete, independent analyses or verification of the data given to it by the company for thousands of patients.
Such reams of data would have taken months to review, noted Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research.
The last of the approved vaccine products to be authorized for general use in the United States, the J & J vaccine has been less popular than the first two inoculations, which were developed by Pfizer-BioNTech and Moderna.
The J & J shot has been given to only 15.2 million people while the Pfizer product has been administered to 236 million individuals, while 153 million people have received the Moderna shots in the US, according to the CDC.
After a string of blood clotting incidents occurred after administration of the shot in the Spring of 2021, US health officials lifted an 11-day pause on the J & J inoculation in April after a review. Experts recommended at that time that it did in fact meet all appropriate safety standards despite the several instances of blood clots that took place after inoculations.
On Friday, Johnson & Johnson officials noted in a new safety analysis that not one single case of the rare clotting syndrome, called thrombosis with thrombocytopenia syndrome (TTS), occurred in the Johnson & Johnson booster shot trials.