The FDA and the CDC are requesting that the Johnson & Johnson vaccine be halted in the United States after six women developed rare blood clots and one died after receiving the vaccine.
FDA, CDC recommends pause on using J&J COVID-19 vaccine
The one-shot COVID-19 vaccine has been administered to seven million people in the US. The percentafe of people who have had blood clots as a result of that is 0.00008. The two authorities are not revoking the emergency authorization, but they request that it be put on hold until further information is gathered. Specific states must now decide if to follow their advice and halt the rollout or continue.
"As of 4/12, 6.8 million doses of the Johnson & Johnson COVID-19 vaccine had been sent out in the US." The CDC and the FDA are analyzing evidence from 6 confirmed cases of a rare and severe form of a blood clot in people who received the vaccine in the country, Daily Mail reported.
"At the moment, these side effects happen to be exceedingly unusual." The CDC and FDA said in a joint statement that the treatment for this particular form of blood clot is different from what is usually given.
A press conference will be held at 10 AM EST on Wednesday to address the topic. Following the announcement, the company's stock fell 3% in early Tuesday trading.
The COVID19 -vaccine developed by Johnson & Johnson was approved in the United States on February 27 and by the World Health Organization in March, but it is yet to be approved by individual European countries such as the United Kingdom. The AstraZeneca-Oxford vaccine has also been halted in Europe due to related fears over blood clots.
Thirty individuals out of a total of 5 million who received J&J's COVId-19 vaccine developed blood clots, a rate of 0.0006. The European Medicines Agency, on the other hand, stated that the vaccine's benefits greatly outweighed the risks.
The CDC's Advisory Committee on Immunization Practices, which includes vaccination guidance, will meet on Wednesday, as per NBC News. The committee will further examine these cases and determine their possible relevance, according to the statement, while the FDA will also look into it. "We suggest this delay before the process is completed," the joint statement said.
Johnson & Johnson COVID-19 vaccine caused rare severe blood clots
The rare blood clots accompanied by reduced platelet numbers were first discovered in people in Europe who had acquired the AstraZeneca-University of Oxford vaccine. European officials said it was "possible" that the clots were due to the vaccines. They're still looking at four other clotting cases since receiving the Johnson & Johnson vaccine, which uses similar technologies.
Johnson & Johnson spokesman Jake Sargent said in a statement that the company files all adverse case information about vaccine recipients with health officials.
"At this time, no clear causal association between these rare events and the Janssen COVID-19 vaccine has been established," Sargent added. "We will continue to collaborate closely with analysts and regulators to review the data and promote transparent communication of this data to healthcare providers and the general public," says the company.
Officials advise anyone who has had the Johnson & Johnson COVID-19 vaccine and has severe headaches, abdominal or leg pain, and shortness of breath within three weeks of receiving the shot to call their health care provider. They also want to inform vaccine providers and health practitioners of the "special care" that this sort of clot needs, as per ABC7.
With much fanfare, the FDA granted emergency use authorization to the J&J vaccine in late February in the hopes that its single-dose and easy storage requirements would accelerate vaccinations across the US. Despite this, the shot only allows for a limited portion of the doses provided in the United States, as J&J has been afflicted with development problems and manufacturing failures at a contractor's Baltimore plant. The drugmaker took over the facility last week to ramp up demand and promise the US government of 100 million doses by the end of May.