Most Americans should be given the Pfizer or Moderna vaccines instead of the Johnson & Johnson shot that can cause rare but serious blood clots, U.S. health advisers recommended Thursday.
The strange clotting problem has caused nine confirmed deaths after J&J vaccinations — while the Pfizer and Moderna vaccines don’t come with that risk and also appear more effective, advisers to the Centers for Disease Control and Prevention said.
It’s an unusual move and the CDC’s director, Dr. Rochelle Walensky, must decide whether to accept the panel’s advice.
The U.S. treated the three COVID-19 vaccines that are available to Americans until now as equal options. This is because large-scale studies showed they each offered high protection but early supply was limited. J&J’s vaccine initially was welcomed as a single-dose option that could be especially important for hard-to-reach groups like homeless people who might not get the needed second dose of the Pfizer or Moderna options.
But the CDC’s advisers said Thursday that it was time to recognize a lot has changed since vaccines began rolling out a year ago. More than 200 million Americans are considered fully vaccinated, including about 16 million who got the J&J shot.
New data from unprecedented safety tracking of all those vaccinations persuaded the panel that while the blood clots linked to J&J’s vaccine remain very rare, they’re still occurring and not just in younger women as originally thought.
The advisers voted unanimously in favor of the Moderna and Pfizer vaccines. But they said the shot made by J&J’s Janssen division still should be available if someone really wants it — or has a severe allergy to the other options.
“I would not recommend the Janssen vaccine to my family members” but some patients may — and should be able to— choose that shot, said CDC adviser Dr. Beth Bell of the University of Washington.
The clotting problems first came up last spring, with the J&J shot in the U.S. and with a similar vaccine made by AstraZeneca that is used in other countries. Eventually U.S. regulators decided the benefits of J&J’s one-and-done vaccine outweighed what was considered a very rare risk — as long as recipients were warned.
European regulators likewise continued to recommend AstraZeneca’s two-dose vaccine although, because early reports were mostly in younger women, some countries issued age restrictions.
COVID-19 causes deadly blood clots, too. But the vaccine-linked kind is different, believed to form because of a rogue immune reaction to the J&J and AstraZeneca vaccines because of how they’re made. The clot can develop in unusual locations, including veins that drain blood from your brain. It also forms in patients who have abnormally low levels in platelets, which are responsible for forming clots. Symptoms of the unusual clots, dubbed “thrombosis with thrombocytopenia syndrome,” include severe headaches a week or two after the J&J vaccination — not right away — as well as abdominal pain and nausea.
While it’s still very rare, the Food and Drug Administration told health care providers this week that more cases have occurred after J&J vaccinations since the spring. They occur most in women ages 30 to 49— about once for every 100,000 doses administered, the FDA said.
Overall, the government has confirmed 54 clot cases — 37 in women and 17 in men, and nine deaths that included two men, the CDC’s Dr. Isaac See said Thursday. His report indicated that two more deaths may be possible.
The CDC makes decisions about how vaccines are used in the United States. In comparing the pros and cons of all the vaccines, the panelists agreed that side effects from the Pfizer and Moderna vaccines weren’t as serious — and that supplies now are plentiful.
Nor is J&J still considered a one-and-done vaccine, several advisers noted. The single-dose option didn’t prove quite as protective as two doses of the Pfizer and Moderna vaccines. In addition, extra-contagious mutant viruses are spreading rapidly, so booster doses should be considered.
Many countries have already adopted policies which give priority to Moderna and Pfizer vaccines, such as Canada. But J&J told the committee its vaccine still offers strong protection and is a critical option especially in parts of the world without plentiful vaccine supplies or for people who don’t want a two-dose shot.
While blood clots are rare, “unfortunately cases of COVID-19 are not,” J&J’s Dr. Penny Heaton said.
The U.S. is fortunate in its vaccine availability and Thursday’s action shouldn’t discourage use of J&J’s vaccine in places around the world where it’s needed, said CDC adviser Dr. Matthew Daley of Kaiser Permanente Colorado.
The FDA also warned this week that another dose of the J&J vaccine shouldn’t be given to anyone who developed a clot following either a J&J or AstraZeneca shot.
Some of the first information on side effects from Pfizer vaccinations among younger children was presented to the committee. The CDC had recommended a two dose series in this age range. Over 7 million doses of the vaccine have been distributed so far. However, very few side effects have been reported. About 10 of the 80 cases of severe side effects were reported in men ages 13 and younger.
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