California Pauses Johnson & Johnson Vaccine After Federal Recommendation Over Blood Clot Concerns – Updated

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UPDATED with latest: On the heels of Los Angeles pulling its meager supply of Johnson & Johnson vaccine this morning, California State Epidemiologist Dr. Erica Pan issued the following statement regarding the Coronavirus vaccine:

“Today, the CDC and FDA have recommended a temporary pause in the use of the Johnson & Johnson Covid-19 vaccine out of an abundance of caution. Of over 6.8 million doses administered nationally, there have been six reported cases of a rare and severe type of blood clot with symptoms occurring 6 to 13 days after vaccination.

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“California is following the FDA and CDC’s recommendation and has directed health care providers to pause the use of the Johnson & Johnson vaccine until we receive further direction from health and safety experts. Additionally, the state will convene the Western States Scientific Safety Review Workgroup to review the information provided by the federal government on this issue. As the federal government has said, we do not expect a significant impact to our vaccination allocations. In California, less than 4% of our vaccine allocation this week is the Johnson & Johnson vaccine.”

The last line may seem reassuring but it is, at the very least, misleading. The 4% number is doubtlessly correct, but the allocation is that small because supplies of J&J have dwindled this week without an offsetting rise in Pfizer and Moderna doses.

As a result, overall vaccine supply in Los Angeles was projected to be down 15% this week and another 5% next week. And that was before state and local officials pulled that final 4% of J&J. So the region could be looking at close to 20% fewer doses this week and 25% next week. The dip comes just as Governor Gavin Newsom has approved millions more residents for vaccinations this week, with all Californians 16+ becoming eligible. More on that below.

PREVIOUSLY at 10 a.m.: Concerns about the Johnson & Johnson Coronavirus vaccine were raised this morning following reports that federal health agencies have recommended an immediate pause in use of the single-dose shot after six U.S. recipients developed serious blood clots.

While Los Angeles and Orange counties, and the state, did not immediately say what that could mean for area vaccination sites, the City of L.A. is going to pause use of the Johnson & Johnson vaccine, according to Mayor Eric Garcetti.

“Following guidance from public health officials,” wrote Garcetti on Twitter, “our City-run vaccination program has paused use of the Johnson & Johnson vaccine.”

“Appointments at permanent sites will not be impacted,” he promised. “Angelenos scheduled to receive J&J from our MOVE clinics will receive a 1st dose of Pfizer.”

The mobile vaccination site in Wilmington will switch to the two-dose Pfizer vaccine, City Councilman Joe Buscaino said.

Buscaino issued a statement Tuesday saying, “City of Los Angeles Mobile Vaccine Site which begins vaccinations today (Tuesday) in Wilmington will switch from its intended Johnson & Johnson vaccine distribution to Pfizer today.”

CBSLA, meanwhile, quoted an L.A. Fire Department spokesperson confirming the vaccination site at Cal State Los Angeles would be offering people with Johnson & Johnson appointments the option of getting a Moderna or Pfizer vaccine, based on eligibility.

L.A. County this week received an allocation of 323,470 total doses of vaccine — including Johnson & Johnson, Pfizer and Moderna. That represents an overall drop of roughly 80,000 from last week. The drop is due to a 88% reduction in supply of the Johnson & Johnson vaccine this week caused by a manufacturing error that invalidated 15 million doses of the vaccine.

California health officials announced last week that while that week’s allocation of J&J was a robust 574,900 doses, this week’s would be just 67,600 and next week’s will be 22,400. The timing is not good.

On Friday, Governor Gavin Newsom is opening up vaccinations to all California residents over 16 years old. That will add millions of eligible people just as the overall vaccine supply was expected to dip 15% because of the manufacturing-related J&J shortage. The overall supply was expected to dip another 5% next week.

Now, those overall numbers will be cut even further as J&J is pulled out of the equation entirely.

County health officials were anticipating supplies of the Johnson & Johnson vaccine to being increasing again in the coming weeks — but now new questions could change plans.

According to joint statement from the Food and Drug Administration and the U.S. Centers for Disease Control, the federal government is recommending an immediate pause in the use of the Johnson & Johnson vaccine nationwide after the six U.S. recipients — all women between the ages of 18 and 48 — developed serious blood clots within two weeks of getting vaccinated.

One woman died and a second woman in Nebraska was hospitalized in critical condition.

“We are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, and Dr. Anne Schuchat, principal deputy director of the CDC, said.

“This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.

The statement also emphasized that the adverse reactions to the J&J vaccine “appear to be extremely rare.”

“More than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S,” the statement said. “CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine.

“In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination.

“Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.”

The CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance.

Dr. Anthony Fauci addressed the news today during the White House Covid-19 Response Team’s television update. “One of the questions that comes up already rather frequently is, ‘Does this have anything to do with the efficacy of the vaccine?’ So we know that there have been 6.85 million doses of J&J distributed in the United States thus far. Someone who had it maybe a month or two ago might say, ‘What does this mean for me?’ It really doesn’t mean anything. You’re OK because if you look at the time frame when this occurs, it’s pretty tight — from a few days, six to 13 days, from the time of the vaccination.

“The next question is one we’re all obviously aware of: What impact is this going to have about people’s attitudes about vaccines in general?” Fauci continued. “So you might know that there have been now 120 million people that have received at least one dose of a vaccine. Most of that – subtract the 6.85 million – is in the messenger RNA from Pfizer and from Moderna. There have been no red-flag signals from those. So you’re talking about tens and tens and tens of millions of people who’ve received vaccines with no adverse effect. This is a really rare event, if you look at what we know so far.”

Published reports quoted a Johnson & Johnson statement as saying, “At present, no clear causal relationship has been established between these rare events” and the company’s vaccine.

“We continue to work closely with experts and regulators to assess the data and support the open communication of this information to healthcare professionals and the public,” the statement added.

City News Service contributed to this report.

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