U.S. health officials will likely say that vaccinations with Johnson & Johnson‘s single-dose shot can resume, as early as this weekend.
Two U.S. officials told the Washington Post that the vaccine will likely now carry a warning about rare, but potentially life-threatening blood clots, similar to one used in the EU.
Vaccinations with J&J’s shot were paused last week after nine reports of a rare possible reaction to the vaccine involving blood clots. Six of the reactions were in women aged 18 to 48.
Regulators are not expected to place an age limit on who can receive the vaccine.
No doses made at the plant have been shipped in the U.S. and distribution of the shot is paused amid blood clot concerns
Weekly supply of J&J’s shot was halted after the pause was placed on the vaccine last week. So far, just shy of eight million doses have been given, and 17.6 million have been distributed
Officials spoke on the on condition of anonymity, because the recommendation is supposed to be made on the basis of a determination to be made by the Centers for Disease Control and Prevention’s (CDC) vaccine panel.
That group, the Advisory Committee on Immunization Practices (ACIP), is meeting tomorrow to discuss data on blood clots linked to the vaccine.
Publicly, officials have punted and refused to give Americans an idea of when J&J vaccinations might resume, while the committee deliberates.
‘I don’t want to get ahead of the advisory committee tomorrow’s meeting,’ said CDC director Dr Rochelle Walensky on the Today show Thursday.
The committee, she noted, will review data on additional cases of blood clots linked to the vaccine that may have come in since the initial report.
Officials, including Dr Walensky and those who spoke to the Post, have also refused to disclose how many additional cases there have been, but have hinted that the figure is low.
‘I don’t want to get ahead of the advisory committee tomorrow’s meeting,’ said CDC director Dr Rochelle Walensky on the Today show Thursday (pictured)
‘We are encouraged that it hasn’t been an overwhelming number of cases but we’re looking and seeing what’s come in,’ said CDC director Dr Rochelle Walensky during a press briefing on Monday.
If that remains the case, vaccinations will likely resume almost immediately, but if more cases suddenly flood in, health officials may reconsider their current leanings.
Last Tuesday, the CDC and Food and Drug Administration (FDA) issued a joint statement announcing a pause due to concerns over blood clots.
Initially, there were seven reports of a combination of clotting and a low platelet count condition known as thrombocytopenia.
One person in the J&J trial developed the condition and died. Since the rollout of the shot began in the U.S., six women between 18 and 48 developed the condition after vaccination. Some developed clots that prevent blood from draining from the brain, a life-threatening condition.
Since then, another two cases have been identified: Another woman who got J&J’s shot during the rollout and another person in the clinical trial.
Dr Walensky’s statement suggests there have been more cases reported sense, but not many.
Nearly eight million doses of J&J’s shot have been administered to-date in the U.S.
That means that the chances of developing a blood clot after receiving the vaccine are about one in a million.
In the general population, these forms of blood clots strike about five out of every one million people.
You are about twice as likely to get struck by lightning in your lifetime as you are to develop a blood clot after getting J&J’s shot, so far.
EU regulators placed a pause on J&J vaccinations as well, but said this week that it should carry a warning about clots, but its use should not be restricted.
A similar pause was placed on AstraZeneca’s shot in the EU, due to blood clot concerns.
Rates were higher, however, and some countries have recommended an age limit, with Italy and the UK advising that people under 30 should get an alternative vaccine.
Yesterday, FDA inspectors found unsanitary conditions and a laundry list of problems that need to be fixed at the Baltimore Emergent BioSolutions facility meant to be producing J&J’s vaccine (file)
J&J will undoubtedly be relived if and when the pause is lifted – as will states, which have not been able to give out the shot – but its woes aren’t yet over.
Yesterday, FDA inspectors found unsanitary conditions and a laundry list of problems that need to be fixed at the Baltimore Emergent BioSolutions facility meant to be producing J&J’s vaccine.
The facility has not yet been authorized to make the shots, and last month ruined 5 million doses due to an ingredient mix-up.
None of the doses distributed in the U.S. so far have come from the unauthorized plant and were instead shipped from a facility in The Netherlands.
But J&J is now behind its goal of providing 100 million doses to the U.S. by the end of June.
And the Biden administration has already purchased another 100 million doses, so getting an additional facility on line could be a critical boon to the firm’s production capacity.