US suspends use of J&J Covid-19 vaccine due to risk of blood clots

J&J shares fell 3% after the FDA and the Centers for Disease Control and Prevention suspended vaccine use to investigate a link to blood clots in six women receiving the J&J vaccine.

Johnson & Johnson (JNJ) shares plummeted 3.6% in early trading on Tuesday (as of this writing) amid news that the Food and Drug Administration (FDA) and the Centers for Control and US Disease Prevention (CDC) has temporarily suspended the use of the J&J COVID-19 vaccine.

“We recommend that you pause the use of this vaccine for reasons of caution,” the US health authorities said.

According to regulators, the reason for the suspension is the identification of rare cases of severe side effects in the form of blood clots after vaccination with J&J. Six women in the United States, aged 18 to 48, developed a rare bleeding disorder 6-13 days after vaccination.

Johnson & Johnson said there was no “clear causal relationship” between the blood clots and the vaccine, but added that the company is working closely with regulators to evaluate the data.

CDC officials said the Advisory Committee on Immunization Practices (ACIP) will meet on Wednesday to further review these cases and assess their potential significance. The FDA will review this analysis as it is also investigating these cases.

Regulators noted that “these side effects are extremely rare at this time,” and pointed out that as of December 4, more than 6.8 million doses of J&J vaccine had been administered in the United States.

The J&J vaccine has been approved by the US government for emergency use of its vaccine in a pandemic after just two months of testing. Full approval of a vaccine usually requires at least six months of research data.

The Johnson & Johnson vaccine was considered by many experts as more preferable compared to analogues from Pfizer (PFE) and BionTech (BNTX) and Moderna (MRNA), since it requires only one dose, not two doses to form persistent immunity against the COVID-19 virus. …

Opponents rallied early on Tuesday amid J&J trouble, with Pfizer rallying 1.18% and Moderna a whopping 8%.

Some US health officials have raised concerns that the delay in the use of the J&J vaccine could reduce the rate of vaccination of the US population, and that the supply of double-dose vaccines from Pfizer and Moderna will not be able to quickly cover the shortage of J&J vaccines.

Although cases of blood clots after the J&J vaccine are rare, and even if they are not proven to be side effects, this creates a negative reputation for the company’s drug.

After the AstraZeneca vaccine, developed in partnership with the University of Oxford, a rare side effect of blood clotting problems has also been identified, as confirmed by the European Medicines Regulator. AstraZeneca has not been approved for use in the United States.

Rare allergic reactions following Pfizer-BioNTech and Moderna vaccinations for COVID-19 are also being investigated by the US National Institutes of Health (NIH). According to the NIH, the trials will involve 3,400 adults between the ages of 18 and 69 at 35 allergy research centers across the country.

Dr. Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, said: “The information gathered from this trial will help doctors educate people with severe allergies or serious illnesses about the risks and benefits of getting these two vaccines. For most people, however, the benefits of being vaccinated against COVID-19 far outweigh the risks. ”

If someone has a serious allergic reaction after receiving the first dose of the Covid-19 vaccine, the CDC recommends not receiving a second dose of that vaccine, even if the allergic reaction was not severe enough to warrant emergency treatment.

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