Moderna, J&J boosters get green light
CDC director affirmed advisory panel's recommendation; J&J recipients cleared to get second shot at least 2 months after first, while Moderna boosters recommended for elderly and others at high risk
As expected, boosters for people treated with all three authorized COVID-19 vaccines in the United States have been cleared by federal authorities. After the CDC’s Advisory Committee on Immunization Practices made its recommendation, CDC Director Dr. Rochelle Walensky approved booster doses of both the Moderna and Johnson & Johnson (Janssen) vaccines as follows:
“For individuals who received a Pfizer-BioNTech or Moderna COVID-19 vaccine, the following groups are eligible for a booster shot at 6 months or more after their initial series:
65 years and older
Age 18+ who live in long-term care settings
Age 18+ who have underlying medical conditions
Age 18+ who work or live in high-risk settings
“For the nearly 15 million people who got the Johnson & Johnson COVID-19 vaccine, booster shots are also recommended for those who are 18 and older and who were vaccinated two or more months ago.”
While the Moderna boosters are half-doses of the original series, the CDC did not specify whether those getting boosters after initial doses of the J&J shots should get a booster of J&J or one of the mRNA vaccines. Data presented to FDA and CDC indicated that the “mix and match” approach is safe and generates a very strong immune response.
During the advisory committee meeting, experts presented and advisors reviewed data on reported and investigated adverse events as well as both clinical study and “real world” data on vaccine effectiveness. My observations:
All three vaccines (Pfizer, Moderna and J&J) have remarkable safety profiles. The number of severe adverse reactions is very small for all three vaccines, and the vast majority of these are treatable. The number of deaths attributable to any one of the three vaccines is even smaller.
All three vaccines are keeping millions of people out of the hospital, including millions who are not getting COVID-19 because of the vaccinations.
Although the J&J vaccine efficacy appears to “top out” around 70%, its efficacy appears stable and durable at that level. With a booster, efficacy is in the same 90-95% range as the mRNA vaccines.
The Moderna vaccine seems to be the winner of the durability contest, with some of the ACIP members noting that most people who got the Moderna vaccine and are not at high risk of COVID-19 are well protected — without boosters.
Cases of myocarditis, an inflammation of the heart, were more common among young men treated with either the Pfizer or Moderna shots, but still rare — about 10 cases per million vaccine doses, and two-thirds fully recover within six weeks of standard myocarditis treatments.
There have been a few more cases of serious blood clots after the J&J vaccine — bringing the total to 47 cases including five deaths out of 15.3 million doses administered. There also appears to be an association between the J&J vaccine and Guillain-Barre syndrome, a very rare, serious reaction between the immune system and the neurological system. It has been associated with other vaccines. The rate is estimated at less than 16 cases per 1 million doses of J&J vaccine administered.
All of the presentations and data are available on the CDC website.
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