Most Americans should get Pfizer or Moderna vaccines instead of Johnson & Johnson’s vaccines, which can cause rare but serious blood clots, US health advisers recommended Thursday.
The bizarre blood clotting problem has been responsible for nine confirmed deaths since the J&J vaccine – while the Pfizer and Moderna vaccines pose no such risk and also appear to be more effective, advisers from the Centers for Disease Control and Prevention said.
This is an unusual move and the CDC director, Dr. Rochelle Walenski, must decide whether to accept the committee’s advice.
So far, the United States has viewed all three COVID-19 vaccines available to Americans as equal choices, as large studies have shown that they all provide reliable protection and supplies were limited early on. Initially, J&J vaccine was welcomed as a single dose option, which may be especially important for hard-to-reach populations, such as the homeless, who may not receive the required second dose of Pfizer or Moderna variants.
But on Thursday, CDC advisers said it was time to acknowledge that a lot has changed since the vaccine was launched a year ago. More than 200 million Americans are considered fully vaccinated, including about 16 million who received the J&J vaccine.
New data from unprecedented safety tracking of all of these vaccines convinced the panel that while blood clots associated with J&J vaccine remain very rare, they still occur, and not just in young women, as originally thought.
The advisers unanimously agreed that the safer vaccines Pfizer and Moderna were preferred. But they said the image taken by J&J Janssen’s division should still be available if someone really wants it or is seriously allergic to other options.
“I would not recommend the Janssen vaccine to my family members,” but some patients may – and should be able to – choose the vaccine, ”said CDC adviser Dr. Beth Bell of the University of Washington.
READ MORE: Why can COVID vaccine cause rare blood clots? Researchers have found clues
Clotting problems first surfaced last spring when J&J shot in the US and a similar vaccine produced by AstraZeneca that is used in other countries. In the end, US regulators decided that the benefits of the single-dose J&J vaccine outweighed what was considered a very rare risk if recipients were warned.
European regulators also continued to recommend the two-dose AstraZeneca vaccine, although since early reports were mostly in young women, some countries have introduced age restrictions.
COVID-19 also causes fatal blood clots. But the vaccines associated with the vaccine are different: they are presumed to result from a spurious immune response to J&J and AstraZeneca vaccines because of how they are made. It forms in unusual places, such as the veins that drain blood from the brain, and in patients who also develop abnormally low levels of platelets that form clots. Symptoms of the unusual clot, called thrombosis with thrombocytopenia syndrome, include severe headaches a week or two after the J&J vaccination, rather than immediately, as well as abdominal pain and nausea.
While this is still very rare, the FDA this week told healthcare providers that more cases have been reported since the spring following J&J vaccinations. They are most common in women between the ages of 30 and 49, according to the FDA – about once in every 100,000 doses given.
Overall, the government has confirmed 54 blood clots – 37 in women and 17 in men and nine deaths, including two men, Dr. Isaac Si of the CDC said Thursday. He said two more people were suspected.
The CDC is deciding how vaccines should be used in the US, and its advisers have called the continuing deaths alarming. Comparing the pros and cons of all vaccines, panellists agreed that the side effects of the Pfizer and Moderna vaccines were not so severe – and that there are now many.
Several advisers noted that J&J is still not considered a one-time vaccine. The single dose option was not as protective as the two doses of Pfizer and Moderna vaccines. In addition, due to the proliferation of highly infectious virus mutants, booster doses are now recommended.
Several countries, including Canada, already have policies favoring Pfizer and Moderna vaccines. But J&J told the committee that their vaccine continues to provide strong protection and is a critical option, especially in parts of the world where there is insufficient vaccine supply or for people who do not want to get a two-dose injection.
Although blood clots are rare, “unfortunately there are no cases of COVID-19,” said J&J’s Dr. Penny Heaton.
The US is fortunate in the availability of the vaccine, and Thursday’s action should not discourage J&J vaccine from being used in places around the world where it is needed, said CDC adviser Dr. Matthew Daly of Kaiser Permanente Colorado.
The FDA also warned this week that another dose of J&J vaccine should not be given to those who develop a blood clot following the J&J or AstraZeneca vaccine.
The committee also heard some of the first data on the side effects of Pfizer vaccination in young children. Earlier last month, the CDC recommended a two-dose series for this age group, and over 7 million doses have been administered to date. But no problems were reported. Of the 80 reported serious side effects, about 10 were associated with a form of inflammation seen in adolescent boys and young adults.
Editor’s Note: Johnson & Johnson is a sponsor of the PBS NewsHour.