FDA & CDC Recommend to Pause J&J coronavirus vaccine use

The United States Food & Drug Administration (FDA) and the U.S Centers for Disease Control & Prevention (CDC) recommend that America pause the use of Johnson & Johnson’s coronavirus vaccine over six reported cases of a severe and rare type of blood clotting. At present, one individual is in critical condition, and another, a forty-five-year-old Virginia woman, died after receiving the vaccination.

Today FDA and @CDCgov issued a statement regarding the Johnson & Johnson #COVID19 vaccine. We are recommending a pause in the use of this vaccine out of an abundance of caution.

— U.S. FDA (@US_FDA) April 13, 2021

The six reported cases of coronavirus patients were among over 6.8 million doses of the Johnson & Johnson vaccine directed in the U.S. According to a joint statement from Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation & Research, and Dr. Anne Schuchat, principal deputy director of the CDC, all these six cases with blood clots occurred among women between the ages of eighteen and forty-eight, whereas symptoms occurred six to thirteen days after vaccination.

The statement states that CDC will organize a meeting of the Advisory Committee on Immunization Practices on Wednesday to review these cases more deeply and evaluate their potential significance. FDA will evaluate that analysis as it also investigates these rare cases. The statement further adds that Until the competition of the process, they recommend a pause in its use out of an abundance of caution. It is crucial to ensure that the health care benefactor community is aware of the possibility of these contrary events and can plan for proper management and recognition because of the special treatment needed with this type of blood clot.

The Rare Event of Blood Clotting

J&J stated that it settled to delay the start of its vaccine in Europe proactively. It also said on Tuesday evening to pause vaccinations in all of its coronavirus vaccine clinical trials while they update guidance for participants and investigators. In an earlier statement, Johnson & Johnson said that they have been working in collaboration with health authorities and medical experts, and they are strongly backing the open communication of this information to the public and healthcare professionals.

For people who received the vaccine shots of Johnson & Johnson, those who developed symptoms such as shortness of breath, abdominal pain, severe headache, or leg pain within three weeks after vaccination should contact their health care provider. In addition, the statement noted that these contrary events of side effects seem to be extremely rare.

Executive associate dean of the Emory University School of Medicine (Emory University) at Grady Health System, Dr. Carlos del Rio, tells John Berman and Poppy Harlow of CNN that it is a rare event. In other words, it is around one person per million, and when a company gives millions of vaccine doses, one can see events like this but could not see in the clinical trial just because millions of people didn’t enroll in those trials.

However, Dr. del Rio congratulate the FDA and the CDC for instantly jumping on it, halting the vaccination process, and seriously trying to understand the reason behind this. Vaccine safety has always been a priority, and this is exactly the move until understanding what’s going on and the way next. He adds that the blood clotting might lead to how the J&J vaccine is an adenovirus vector vaccine – the same vaccine type as the COVID-19 vaccine of AstraZeneca.

Still, People Should get Vaccinated

The AstraZeneca vaccine is not used in the U.S., but around seventy countries authorized it for its use. Recently, the European Medicines Agency reached a result that unusual blood clots with short blood platelets should list as very rare side effects of the AstraZeneca vaccine. Del Rio said that the two other coronavirus vaccines approved for emergency use in the United States – Moderna and Pfizer’s vaccines – are mRNA vaccines, which are a different type of the vaccine.

Moreover, Rio still recommends people to receive vaccination against the coronavirus. FDA’s Marks said that, in general, it appears to be similarities between the rare blood clotting incidents might associated with the AstraZeneca and J&J’s COVID-19 vaccine. Marks adds that the AstraZeneca is a chimpanzee adenoviral vector vaccine, and they are from the same general class of viral vectors. The mechanism behind the blood clotting incidents in patients who receive the J&J vaccine remains unclear – but possibly similar to the mechanism behind possible events linked with the AstraZeneca vaccine.

Federal Health Officials to Stop using Johnson & Johnson Vaccine Immediately

The latest announcement from the CDC and the FDA means all U.S. federal health channels, such as community health centers, mass vaccination sites, and others, who were administering the J&J vaccine will instantly stop it for the time being, according to a source from federal health. The health agencies are suggesting that other states do the same, but it will be up to every individual state’s decision because they have a separate allocation of doses. However, the rare type of blood clotting after receiving vaccination shots requires unique treatment.

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