The FDA and the CDC recommend a lift to the pause on administering Johnson & Johnson Covid-19 vaccines after the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended today that vaccinations should be resumed for all U.S. adults over the age of 18.
In the past several weeks, 15 people in the U.S. who were given the Johnson & Johnson Covid-19 vaccine were diagnosed with a rare type of blood clot, three of whom have died.
The majority of people who have reported a blood clot associated with the vaccine so far are women under the age of 50; in this age group, the approximate risk for rare blood clots is 7 in one million.
A risk assessment by the CDC found that if all U.S. adults were able to get the Johnson & Johnson vaccine again, there would be 26 cases of blood clots and 1,435 lives saved.
Members of the CDC’s vaccine committee decided that the benefits of the vaccine outweigh the risks both on a population and individual level.
Some committee members said that they would be interested in putting age or gender restrictions on who could receive the Johnson & Johnson vaccine, but other members said that these restrictions would be difficult to implement on a large scale and could be confusing to members of the public.
“Both agencies have full confidence that this vaccines’ known and potential benefits outweigh its known and potential risks,” said acting CDC Commissioner Janet Woodcock in a press briefing on Friday. “The FDA has updated both the fact sheet for healthcare providers and the fact sheet for recipients and caregivers to include information on the risk of this rare syndrome”.
The vote to resume comes after a 10-day pause on the Johnson & Johnson vaccine that was recommended by the FDA and CDC after reports of rare blood clots began to surface in mid-April. The vaccine committee first reviewed reports of blood clots associated with the Johnson & Johnson vaccine on April 14th, and decided that at that time there was not yet enough information to recommend whether to resume using the vaccine.
The rare type of blood clots seen in connection with the Johnson & Johnson vaccine are similar to blood clots that have been linked to the AstraZeneca vaccine in Europe. Earlier this week, the European Medicines Agency decided that the Johnson & Johnson vaccine should be available to all adults in the E.U., albeit with a safety warning.
The debate over whether to pause the vaccine in the U.S. has quickly become an issue of vaccine equity, given that Johnson & Johnson vaccine is being used in vulnerable populations, including the homeless and homebound. The single-shot vaccine is also being heavily relied on by lower-income countries, many of which lack the infrastructure to use mRNA Covid-19 vaccines.
1 in 3. That’s how many U.S. adults are already fully vaccinated against Covid-19. More than 50% of American adults have gotten at least one dose of a Covid-19 vaccine.
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Though vaccinations with the Johnson & Johnson vaccine will now resume, the vaccine may not be available to everyone who wants one. Contamination issues at a facility in Baltimore last month led to 15 million doses of the vaccine being discarded and a lower than expected number of doses delivered across the country. However, government officials have said that there are 9 million doses ready to distribute as soon as the pause is lifted.