Johnson & Johnson’s COVID-19 vaccine will remain in limbo for some time after government health advisers stated on Wednesday that they need more evidence to decide if a handful of unusual blood clots were linked to the injection – and if so, how big the risk really is. is.
The reports are extraordinarily rare – six cases of the more than 7 million US vaccinations with the single-dose vaccine. But the government recommended a break in J&J vaccinations this week, not long after European regulators stated that such clots pose a rare but possible risk with the AstraZeneca vaccine, an injection made in a similar fashion but not yet approved for use in the USA.
At an emergency meeting, advisers from the Centers for Disease Control and Prevention grappled with the fact that the US has enough alternative shots to vaccinate the population, but other countries anxiously awaiting the one-time vaccine may not.
“I continue to feel that we are in a race against time and the variants, but we have to move forward in the safest possible way,” said CDC advisor Dr. Grace Lee of Stanford University, who was among those striving to postpone a vote on the vaccine.
Authorities have only studied the clots for a few days and have little information to assess the shot, agreed fellow counselor Dr. Beth Bell of the University of Washington.
“I don’t want to send the message that there is something fundamentally wrong with this vaccine,” said Bell. “It is a very rare event. Nothing in life is without risk. But I want to be able to understand and defend the decision I made based on a reasonable amount of data. “
These are not everyday blood clots. They occurred in unusual places, in veins that drain blood from the brain, and in people with abnormally low levels of clot-forming platelets. The six cases raised an alarm because that number is at least three times more than experts expected, even from more typical brain drainage clots, said Dr. Tom Shimabukuro of the CDC.
“What we have here is a picture of clots forming in large vessels where we have low platelets,” explained Shimabukuro. “This usually doesn’t happen,” but it is comparable to European reports on the AstraZeneca vaccine.
The good news: The government says there are no signs of similar blood clots following vaccination with the Pfizer and Moderna injections that are the mainstay of the US COVID-19 battle.
The J&J cases now being investigated are all among women under the age of 50. But the advisory panel stressed that there isn’t enough information to say if only certain groups are at risk. In Europe, most, but not all, post-AstraZeneca cases occurred in women under 60, so different countries used that vaccine in different ways.
Also, a 25-year-old man developed a similar blood clot while testing J & J’s vaccine in the US, something the government was watching closely at the time, but could not relate to the shot. On Wednesday, the company also brought the CDC’s attention to a woman whose clot was not occurring in the brain, raising more questions about what other evidence to investigate.
The CDC expects its advisers to reconsider the evidence within two weeks. So far, the clots have occurred between one and three weeks after people received the J&J vaccine, and officials warned more reports could emerge.
Concerns about the clots could undermine public confidence in a vaccine that many hoped would help some of the hardest to reach populations – in poor countries or in places like homeless shelters in the US.
But the US is closely monitoring COVID-19 vaccines because side effects too rare to have occurred in studies of thousands of people sometimes crop up when millions of injections have been used. Shimabukuro said noticing such a rare potential risk amid the massive vaccine rollout in the country “is an example of a vaccine safety success story.”
Some vaccine specialists, closely monitoring the deliberations, expressed dismay that the public – at home and abroad – will have to wait for more advice.
“What they did was punt them,” said Dr. Paul Offit, a vaccine expert at Children’s Hospital in Philadelphia. “I just don’t think waiting will give you a critical amount of information to help you make a decision.”
He noted that many European countries are dealing with the AstraZeneca uncertainty without stopping its use.
Health officials have recommended the J&J timeout in part to make sure doctors know how to recognize and treat the unusual condition. The CDC said on Wednesday that four out of six women with the unusual blood clots were treated with a blood thinner called heparin – a treatment the government is warning doctors to avoid.
The setback for J&J comes as the global death toll from COVID-19 approaches 3 million, including more than 560,000 who perished in the US, who continue to report tens of thousands of new infections and an average of nearly 1,000 deaths every day.
So far, the J&J vaccine has been a minor player in US vaccinations. More than 122 million Americans have received at least one dose of vaccine and nearly 23% have been fully vaccinated. Moderna and Pfizer are on track to deliver 300 million doses each by mid-July to the end of July.
Vaccinations are slower in Europe, where many countries have difficulties with their supplies. J&J has delayed some of its European deliveries due to the clot evaluation, but Poland said it would use the party it already controls. European medical regulators plan to release their own evaluation of the J&J clot problem next week.
When the blood clots were noticed after the AstraZeneca vaccinations, scientists in Norway and Germany pointed to the possibility that some people might experience an abnormal immune response, forming antibodies that turn off their platelets. That is the theory as the US is now examining the J&J reports.
Associated Press Health author Matthew Perrone contributed to this report.
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