The Food and Drug Administration said Wednesday it is fighting whether recipients of the single-shot Johnson & Johnson COVID-19 vaccine need another dose – six months or two months early.
In an online review, FDA scientists did not reach a definitive conclusion, citing shortcomings with J&J data, including little information on protection against the additional infectious delta strain of the corona virus.
The review comes ahead of Thursday’s and Friday’s meetings when an FDA advisory panel will recommend returning booster doses of both J&J and modern vaccines. This is a step in the government’s vaccine review process: next week, the FDA will make a final decision on authorizing these boosters, and then the Centers for Disease Control and Prevention will discuss what actually happened. Who should they meet?
Health officials say all vaccines used in the United States provide strong protection against serious illness or death from Covid 19. But amid signs that the protection against mild infections is fading, the government has already cleared booster doses of the Pfizer vaccine for some people starting six months after their last shot.
Aiming at similar recommendations, Moderna similarly asked the FDA to clean up its booster diet in six months. But J&J complicated the decision by proposing a second shot in two to six months.
FDA reviewers wrote that a study of a two-month booster plan shows that “there may be some benefit”, while pointing to only a small number of people who took a second shot instead of six months. ۔
Overall, the J&J vaccine “still protects against severe COVID-19 disease and death,” the FDA reviewers concluded. But its effectiveness is “permanently lower” than the protection seen with Data Pfizer and Modern Shots.
As part of this, J&J has entered data from a real-world study with the FDA showing that its vaccine is 80% effective against hospital admissions in the United States.
J&J’s single-dose vaccine was highly anticipated to form another of his works. But its rollout was damaged by a series of troubles, including manufacturing problems and some rare but serious side effects, including blood clotting disorders and a neurological reaction called Galen Berry Syndrome. In both cases, the regulators decided that the benefits of the shot far outweighed the risks.
Rival pharmaceutical companies Pfizer and Modern have provided the majority of the American Covid 19 vaccine. More than 170 million Americans have been fully vaccinated with two dose shots from these companies, while less than 15 million Americans have received J&J shots.