CDC, FDA Recommend Pause of Johnson & Johnson COVID-19 Vaccine Model

By: Michael Mandarino, Follow South Jersey Managing Editor

Editor’s Note: This story has been updated to reflect New Jersey’s decision to pause use of the Johnson & Johnson vaccine.

SOUTH JERSEY — The United States has recommended a pause in the use of Johnson & Johnson’s single-shot COVID-19 vaccine as it investigates six rare blood clot cases in women aged 18 to 48.

The Centers for Disease Control and the Food and Drug Administration released a joint statement on Tuesday saying that they were investigating six blood clot cases linked to the Johnson & Johnson vaccine model. The blood clots occurred in veins that drain blood from the brain, and they appeared along with low platelet counts in the six women in question. These reported cases appear to be similar to the blood clotting that prompted European countries to stop administering doses of the AstraZeneca COVID-19 vaccine model, which isn’t approved for use in the United States.

The CDC’s Advisory Committee on Immunization Practices will meet Wednesday to discuss these cases. The FDA will also launch an investigation into the cause of the blood clots and low platelet counts, but both entities are advising a pause on the use of the Johnson & Johnson vaccine until they have more information. New Jersey Governor Phil Murphy announced that the state will pause use of the Johnson & Johnson vaccine via Twitter on Tuesday morning.

Tuesday’s joint statement from the FDA and CDC has no impact on the two-dose Pfizer and Moderna models, which account for 96% of all vaccinations in New Jersey and the overwhelming majority of vaccinations nationwide.

The CDC reported that more than 6.8 million Americans have received the single-shot Johnson & Johnson COVID-19 vaccine. The vast majority of those people had mild or no side effects from the vaccine. In New Jersey, 4% of all vaccinations, or more than 217,000 doses, were the Johnson & Johnson model. One particular clinic in Cumberland County administered 800 doses of the Johnson & Johnson vaccine last week.

One man from Edison, New Jersey tested positive for COVID-19 and was hospitalized with severe symptoms nearly a month after receiving the Johnson & Johnson vaccine, according to a report from ABC-7 in New York. New Jersey officials are aware of this particular case, but they’re adamant that getting sick after receiving your vaccination is the exception, not the rule.

“There are so few cases in Jersey, in the country, in the world where someone has been infected after the vaccine,” Governor Phil Murphy said at his regularly-scheduled COVID-19 briefing on Monday. “I would just not want anyone out there to assume that that’s the norm, because it isn’t. There’s no data at all that suggests that.”

“We’re aware of the case. I have nothing more to add to it. It will happen,” New Jersey health commissioner Judy Persichilli added. “The efficacy could be close to 100% but there’s also a percentage of cases that are either contracted COVID-19 before they got vaccinated or were exposed afterwards and will fall ill. That’s about all that I have on it.”

The FDA issued emergency use authorization for the single-shot Johnson & Johnson vaccine in late February. It did so knowing that the Johnson & Johnson vaccine had a 72% efficacy rate in the United States. However, the Johnson & Johnson vaccine’s clinical trial showed that use of the vaccine stopped all hospitalizations and deaths in the vaccine group while there were 16 COVID-19-related hospitalizations and seven deaths in the control group.

By all accounts, the single-shot Johnson & Johnson vaccine is highly effective in protecting Americans against COVID-19, and cases of blood clotting and COVID-19 infections post-vaccination are the exception, not the rule. However, the exception is serious enough to prompt the CDC and FDA to recommend a pause in use of the vaccine.

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