Pa. ‘pauses’ Johnson & Johnson COVID-19 vaccine after blood clotting reports

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UPDATE: The federal Centers for Disease Control and Prevention and Food and Drug Administration lifted the pause on the Johnson & Johnson vaccine Friday following a safety review, according to a statement from the agencies.

Both agencies have determined that the vaccine is safe and effective in preventing COVID-19, and that the benefits of receiving it outweigh the risks, the statement said.

The Pennsylvania Department of Health has notified local vaccine providers that they may continue administering the J&J vaccine.

ORIGINAL UPDATE: The Pennsylvania Department of Health on Thursday announced that it is extending a “pause” on administering the Johnson & Johnson vaccine for four days, from April 20 to April 24. The department also clarified that a 26-year-old woman from Pennsylvania is among one of six across the country who experienced blood clotting after receiving the shot. This story reflects those changes.

HARRISBURG — The Pennsylvania Department of Health has directed all vaccine providers in the state to “pause” the administration of the Johnson & Johnson COVID-19 vaccine until at least April 24 following reports that six people who received it developed blood clots.

The federal Centers for Disease Control and Prevention and the Food and Drug Administration recommended the pause after six women between 18 and 48 years old in the United States developed cerebral venous sinus thrombosis, a rare but severe type of blood clot, within six to 13 days of receiving the J&J vaccine.

About 6.8 million people nationwide have received the J&J vaccine, which puts the odds of experiencing this side effect at more than one in a million, making it exceedingly rare. Pennsylvania has administered 262,739 of those doses, Acting Health Secretary Alison Beam said during a news briefing Tuesday.

One of those six cases involved a 26-year-old woman from Pennsylvania who was treated in a New Jersey hospital, the health department clarified in a statement Thursday.

The woman has since recovered, but the CDC has not released additional information about the case, the statement said.

It is not clear exactly how many vaccine appointments throughout Pennsylvania will be postponed as a result, but the state was scheduled to receive about 20,000 doses of the J&J vaccine this week, Beam said.

The state’s regional vaccination clinic at the Bryce Jordan Center on Penn State’s University Park campus in Centre County will be on hold until further notice, she said.

While the pause is standard and in line with best scientific practices, health officials are concerned it will feed into fears people might have about vaccinations. They emphasize that vaccinations remain overwhelmingly safe and necessary; it’s the coronavirus that is deadly.

So far, more than 25,000 people in Pennsylvania alone have died because of COVID-19, and vaccinations are the most efficient way to put an end to it.

“There’s been a high level of scrutiny of this vaccine,” Dr. Denise Johnson, Pennsylvania acting physician general, said during the news briefing. “Even though there are only six cases that have come to our attention, we have this pause so that we can evaluate closely what actions need to be taken.”

According to the University of Michigan Health System’s stroke center, only about 5,000 people in the country are diagnosed with the rare clotting a year. One of the most common causes is elevated estrogen or medications with estrogen in them, such as birth control, as well as other medications.

The Wolf administration earmarked its initial doses of J&J’s vaccine for teachers and other school staff. In addition to the Corrections Department, the state is now providing the vaccine to the Department of Human Services and those in the food and agriculture industries.

The J&J vaccine, like the AstraZeneca vaccine, uses a modified piece of a virus — not the virus that causes COVID-19 — to infect cells, trigger the immune system and teach the body to defend itself against the coronavirus, according to the CDC.

Pfizer and Moderna vaccines use messenger RNA, or manufactured genetic materials, which also trigger antibodies, but without a virus.

The pause on administering the J&J vaccine comes on the same day Pennsylvania was scheduled to open up vaccine eligibility to everyone age 16 and older. So far, about 39.5% of Pennsylvania residents have received at least one dose of a coronavirus vaccine, according to data from the Centers for Disease Control and Prevention.

Beam was not able to say whether certain areas of the state or specific vaccination providers have received a greater share of the state’s J&J doses and if, as a result, they might be more affected by the pause on those doses.

In some cases, the J&J vaccine was spread across the vaccine provider network. In other areas, it was sent to mass vaccination sites, like the regional vaccination clinic at Penn State, Beam said.

The pause on J&J vaccines could also slow efforts to vaccinate the state’s farm and food workers, said Liam Migdail, spokesman for the Pennsylvania Farm Bureau. Some doses of the J&J vaccine had been allocated to reach agricultural workers through mobile and on-site vaccination clinics, he said.

The suspension also includes vaccines administered at facilities throughout the state corrections system, which are primarily using the J&J vaccine for both prison staff and incarcerated people.

At least 11 of the state’s 23 prisons had already started receiving vaccines as of April 8.

The J&J vaccine was also used in a three-week initiative to vaccinate teachers and school staff across Pennsylvania that wrapped up more than two weeks ago, according to a statement from the Pennsylvania State Education Association, the state’s largest teachers union. More than 112,500 people were vaccinated as part of that effort.

“We aren’t aware of any school staff members who have reported these side effects, but we will stay vigilant about this,” the statement read.

The state is expected to receive about 270,000 doses of the Pfizer and Moderna vaccines this week, Beam said.

Those vaccines — which require two doses — are not affected by the pause on J&J vaccines.

Some vaccine providers, like UPMC, will be able to proceed with scheduled appointments by replacing the J&J doses with a different vaccine.

The health-care system was scheduled to administer 12,000 J&J doses during a two-day clinic on April 14 and 15 at the Pittsburgh Mills mall, about 20 miles northeast of Pittsburgh, in Frazer. Instead, a UPMC statement clarifies that it will use the Pfizer vaccine.

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