LAURAN NEERGAARD and MIKE STOBBE / Associated Press
Most Americans should get the Pfizer or Moderna vaccines instead of the Johnson & Johnson vaccine, which can cause rare but severe blood clots, US health advisors recommended Thursday.
The strange coagulation problem has caused nine confirmed deaths after J&J vaccinations – while the Pfizer and Moderna vaccines are unrelated to that risk and appear to be more effective too, advisors for the Centers for Disease Control and Prevention said.
It’s an unusual move, and the CDC director, Dr. Rochelle Walensky, must decide whether to accept the advice of the panel.
So far, the US has treated all three COVID-19 vaccines available to Americans as equal choices, as large studies found they all offered strong protection and early care was limited. J & J’s vaccine was initially welcomed as a single-dose option that could be especially important for hard-to-reach groups such as the homeless who may not receive the required second dose of the Pfizer or Moderna options.
But CDC advisors said Thursday it was time to realize that much has changed since the vaccines were launched a year ago. More than 200 million Americans are considered fully vaccinated, including about 16 million who received the J&J vaccination.
New data from an unprecedented safety watch of all of these vaccinations has convinced the panel that while the blood clots associated with J & J’s vaccine are very rare, they still occur and not just in younger women as originally believed.
In a unanimous vote, the advisors decided that the safer vaccines Pfizer and Moderna would be preferred. However, they said that J & J’s Janssen division recording should still 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 might – and should be able – to choose this vaccine, said CDC advisor Dr. Beth Bell from the University of Washington.
The clotting problems first appeared last spring when J&J was injected in the US and a similar vaccine from AstraZeneca that is used in other countries. Ultimately, U.S. regulators decided that the benefits of J & J’s unique vaccine outweighed the very rare risk – as long as recipients were warned.
European regulators also continued to recommend AstraZeneca’s two-dose vaccine, although some countries put age restrictions in place as the first reports were mostly from younger women.
COVID-19 also causes fatal blood clots. But the species associated with vaccines is different, which is believed to form due to a rogue immune reaction to the J&J and AstraZeneca vaccines due to their manufacture. It forms in unusual places, such as veins that drain blood from the brain and, in people who also develop abnormally low levels of platelets, who form clots. Symptoms of the unusual clot known as “thrombosis with thrombocytopenia syndrome” include a severe headache a week or two after the J&J vaccination – not immediately – as well as abdominal pain and nausea.
Although it’s still very rare, the Food and Drug Administration told health care providers this week that there have been more cases after J&J vaccinations since the spring. They are most common in women between the ages of 30 and 49 – about once per 100,000 doses given, according to the FDA.
In total, the government has confirmed 54 blood clot cases – 37 in women and 17 in men, and nine deaths, including two men, said Dr. Isaac Lake from the CDC on Thursday. He said two more deaths were suspected.
The CDC is deciding how to use vaccines in the US, and its advisors called the ongoing deaths worrying. Comparing the pros and cons of each vaccine, the panelists agreed that the side effects of the Pfizer and Moderna vaccines weren’t as severe – and that supplies are now plentiful.
J&J is also not still considered a one-time vaccine, several advisors noted. The single-dose option wasn’t quite as protective as two doses of the Pfizer and Moderna vaccines. Since extra contagious virus mutants are now spreading, booster doses are also recommended.
Several countries, including Canada, already have guidelines giving preference to Pfizer and Moderna vaccines. However, J&J told the committee that their vaccine still offers strong protection and is a critical option especially in parts of the world with insufficient vaccine supplies or for people who do not want a two-dose vaccination.
While blood clots are rare, “unfortunately, cases of COVID-19 aren’t,” said Dr. Penny Heaton from J&J.
The U.S. is lucky with vaccine availability, and Thursday’s measures shouldn’t prevent J & J’s vaccine from being used in places around the world where it’s needed, said CDC advisor Dr. Matthew Daley of Kaiser Permanente Colorado.
The FDA also warned this week that another dose of the J&J vaccine should not be given to anyone who has developed a clot after a J&J or AstraZeneca syringe.
The committee also heard some of the first data on reported side effects from Pfizer vaccinations in younger children. Early last month, the CDC recommended a two-dose series for this age group, and more than 7 million doses have been given to date. But few issues were reported. Of the 80 reported cases of serious side effects, about 10 were related to some form of inflammation seen in teenage males and young adults.
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