US officials may take 2 weeks or more to determine if Johnson & Johnson’s vaccine is causing rare blood clots

The CDC is working to collect more data, two senior White House health officials told Politico.
But medical experts fear that withholding the vaccine for much longer may increase the reluctance to vaccinate.
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U.S. federal agencies may need two weeks or more to find out whether Johnson & Johnson’s coronavirus vaccine is linked to rare blood clots, two senior White House health officials told Politico on Saturday.

U.S. regulators recommended a break in distribution of J & J’s vaccine last Tuesday due to six reports of clotting in women who had recently received the vaccine.

The blood clot in question, central venous sinus thrombosis (CVST), forms in the brain, which can lead to a headache or stroke. In an average year, the disease occurs in about five in a million people.

The Centers for Disease Control and Prevention’s vaccine advisory group is scheduled to meet on Friday to discuss whether to end the vaccine hiatus. But two health officials told Politico the CDC may not have enough data by then to determine whether J & J’s vaccine is indeed causing rare clots.

U.S. regulators may eventually consider imposing restrictions based on the age or gender of the vaccine, which has been permitted for people 18 years of age and older. Alternatively, regulators could simply issue stronger warnings about possible blood clots in unusual cases.

Many political leaders and medical experts fear that if regulators take too long to assess the potential blood clot link, a growing share of Americans will lose faith in J & J’s vaccine.

“The longer the break, the longer it will take us to convince people that this particular vaccine is safe again,” Arkansas Governor Asa Hutchinson told Politico.

Peter Gulick, associate professor of medicine at Michigan State University, said the J&J break could delay the prospect of herd immunity – the threshold beyond which the virus will not be able to easily pass from person to person .

“The fear is that upon hearing all of this, the anti-vaxxers and even those on the fence are now falling into the arena of ‘I don’t think I want to get the shot until things get known a little more. Gulick told Insider. “We may have taken two steps back when it comes to our desire to obtain collective immunity. “

Searching for Blood Clots in “Cloudy Water” of Data

Johnson & Johnson’s coronavirus vaccine is given as a single injection, while Pfizer and Moderna require two injections.
Thiago Prudêncio / SOPA Images / LightRocket via Getty Images
The CDC’s vaccine advisory committee has already met once to review rare cases of blood clots. At a meeting last Wednesday, the panel recommended continuing the break on J & J’s vaccine until more data can be collected.

“It’s important from a public perspective: when we say rare, what does that mean? Dr. Beth Bell, professor of global health at the University of Washington, said at the meeting. “I want to be able to feel comfortable with my family and myself to receive this vaccine. “

U.S. regulators are now encouraging doctors to report any cases of post-vaccination CVST in recent weeks. Regulators are also working with Johnson & Johnson to find out more about the six reported cases – specifically, whether the women had any underlying health issues or were taking drugs that may have predisposed them to clotting.

So far, regulators have noticed a few trends: Women were between the ages of 18 and 48. They also had a rare combination of CVST and low levels of platelets – colorless blood cells that cause clots to form.

Before the authorization of the vaccines, this combination was mainly associated with heparin, an anticoagulant. In rare cases, people taking the medicine develop antibodies that bind to a specific platelet, which can make them more susceptible to clots.

“This observation of the low platelet count is part of the mystery and something that needs to be resolved to see if this is related or not,” Namandjé Bumpus, director of the Department of Pharmacology and Molecular Sciences at Johns Hopkins Medicine, told Insider .

But medical experts have stressed the need for more data before further associating clots with any particular group.

“Everything’s like big muddy water and then you just try to clean things up as much as you can to try to gauge what’s going on,” Gulick said.

Vaccinations may slow down for the homeless, prisoners, or rural Americans
Yvonne Gibbs, 72, receives the COVID-19 vaccine from Moderna, at the TCF Center in Detroit.
AP Photo / Carlos Osorio, dossier
Shortly after US regulators announced a break in J & J’s vaccine, White House COVID-19 coordinator Jeff Zients said the recommendation would not affect the pace of the US vaccine rollout.

“We have a more than enough supply of Pfizer and Moderna vaccines to maintain the current rate of around 3 million shots per day,” Zients said at a press briefing Tuesday.

Indeed, many health departments, pharmacies and immunization clinics that were planning to administer Johnson & Johnson were able to quickly procure additional injections so people did not lose their appointments.

But some vaccination sites – especially those in rural areas – have been forced to close temporarily. A state-run mass vaccination site in Aurora, Ill. Was canceled earlier this week, ending appointments for 1,000 people. Around the same time, a Johnson & Johnson clinic in Jefferson County, Ill., Suspended vaccinations.

The J&J break has also slowed the pace of vaccinations for the homeless, prisoners and those unable to leave their homes due to illness or old age. J & J’s vaccine is the only single-dose vaccine authorized in the United States, so it is the easiest to administer. It is also easier to store than Pfizer or Moderna vaccines (it can be stored in standard refrigerators rather than freezers).

On top of that, people may be drawn to J & J’s vaccine if they are afraid of needles or have difficulty taking time off work to get the vaccine.

“We’re actually seeing that some people go for the Johnson and Johnson vaccine just because of their situation – it’s a dose, it’s available, and so on. Johan Bester, director of bioethics at the University of Nevada, Las Vegas School of Medicine, told Insider.

Without the J&J option, medical experts have said, U.S. health officials might have a harder time convincing more Americans to get the vaccine – even as new, more contagious variants are increasing cases across the country.