E.U. Regulator Says J.&J. Shot Ought to Carry Uncommon Clot Threat Label

BRUSSELS – Johnson & Johnson announced Tuesday that its coronavirus vaccine rollout in Europe is due to resume after European Union drug regulators announced they would add a warning to the product highlighting a possible association with rare blood clots that Benefits of the shot, however, outweigh risks.

“The reported combination of blood clots and low platelets is very rare, and the general benefits of the Covid-19 vaccine Janssen in preventing Covid-19 outweigh the risk of side effects,” the European Medicines Agency said in a statement referring to Johnson & Johnson’s vaccine development division, Janssen. The rare blood clots are “very similar,” the agency added, to those associated with the AstraZeneca vaccine, for whom the agency made a similar recommendation.

Johnson & Johnson decided last week to postpone rollout in the bloc’s 27 member states after regulators in the US called for the vaccine to be suspended due to concerns about the possible serious side effects.

The EMA’s recommendation is non-binding, but it is the first hint of what might happen next with the launch of the highly anticipated single vaccine in Europe, which has already been given to nearly eight million people in the US. The agency said regulators in individual EU member states should decide how to proceed, taking into account their particular case load and vaccine availability.

The agency said it made its recommendations in front of U.S. regulators because it built some confidence in the response by spending a lot of time reviewing similar cases that had occurred with the AstraZeneca vaccine.

In its statement, the agency stressed the importance of managing the possible side effects and issued guidelines for health professionals to look out for the rare coagulation disorder.

“Health professionals and people receiving the vaccine should be aware of the possibility of very rare cases of blood clots combined with low platelet levels within three weeks of vaccination.”

Using data already available, the agency said one possible explanation is that the blood disorder was an immune response.

The temporary suspension of Johnson & Johnson’s rollout in the European Union exacerbated the block’s problems with the AstraZeneca vaccine. Vaccination efforts in Europe have been lagging in part because the Anglo-Swedish pharmaceutical company was unable to deliver the number of doses expected in the first quarter of the year. The AstraZeneca vaccine was then suspended due to very similar blood clotting concerns that regulators are currently investigating for Johnson & Johnson’s product.

Although the EU regulator eventually found that the benefits of the AstraZeneca vaccine outweighed the risks and that EU members should use it, the damage had been done. Many Europeans have refused to take the vaccine and several EU countries have restricted its use to the elderly, as most of the people with the rare blood clots were under 60 years of age. The EMA declined to name populations at risk in relation to both the AstraZeneca and Johnson & Johnson vaccines, although most of the reported cases occurred in younger women. The agency said it did not have enough information to draw any definitive conclusions.

What You Need To Know About The Johnson & Johnson Vaccine Break In The United States

    • On April 13, 2021, U.S. health officials called for an immediate halt to use of Johnson & Johnson’s single-dose Covid-19 vaccine after six recipients in the U.S. developed a rare blood clot disorder within one to three weeks of being vaccinated.
    • All 50 states, Washington, DC, and Puerto Rico have temporarily stopped using the vaccine or recommended providers are suspending use of the vaccine. The U.S. military, government-run vaccination centers, and a variety of private companies, including CVS, Walgreens, Rite Aid, Walmart, and Publix, also paused the injections.
    • Fewer than one in a million Johnson & Johnson vaccinations are currently being studied. If there is a real risk of blood clots from the vaccine – which has yet to be determined – the risk is extremely small. The risk of contracting Covid-19 in the United States is much higher.
    • The hiatus could complicate the country’s vaccination efforts at a time when many states are facing spikes in new cases and are trying to address vaccine hesitation.
    • Johnson & Johnson has also decided to delay the launch of its vaccine in Europe amid concerns about rare blood clots, which is taking another blow to the vaccine surge in Europe. South Africa, devastated by a contagious variant of the virus found there, also stopped using the vaccine. Australia announced that it would not buy cans.

The EU announced last week that it would increase its supply of the Pfizer BioNTech vaccine and negotiate a new contract with the company for future booster vaccines for 2022 and 2023 to signal that vaccines like Pfizer and Moderna will have priority mRNA technology.

However, the Johnson & Johnson vaccine was an important part of vaccination schedules from the US to South Africa.

U.S. health officials on April 13 called for a hiatus in vaccine use to investigate a rare bleeding disorder that has occurred in a small number of recipients. Johnson & Johnson suspended the EU rollout immediately afterwards. EU countries had just started receiving their first shipments of the vaccine and all but Poland followed the company’s instructions and have not yet started giving it.

In the United States, the Centers for Disease Control and Prevention said Monday, while federal health officials examined “a handful” of new, unconfirmed reports that have surfaced since the nationwide hiatus, “no additional cases of the rare form of blood clot. ” – Vaccination with the Johnson & Johnson vaccine has been confirmed. “

Dr. Anthony S. Fauci, the foremost infectious disease expert in the United States, previously said he was awaiting a decision to resume administration of the Johnson & Johnson vaccine this Friday as a panel of experts advised the Centers for Disease Control and Prevention is scheduled to meet.

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