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FDA Joins Hands With Europe To Probe Blood Clot Disorder Due To Johnson & Johnson COVID19 Shot

Drug Regulators in Europe have found rare but fatal cases of blood clots in people who have been vaccinated with Johnson & Johnson (J&J) COVID19 vaccine. Now, the US Food and Drug Administration (FDA) as well has joined hands with them to probe such cases and reexamine the safety of the J&J COVID19 vaccine. The officials from the FDA as well have reported serious thromboembolic cases in the US but they have said that there is no casual link with vaccination. However, the federal agency is going to continue its probe that might decide if there is a need for regulatory action against the company’s vaccine.

Last week, the authorities of the European Medicine Agency (EMA) have said that they have found three cases of strange blood clots along with low blood platelets in people after they have been vaccinated with Johnson & Johnson’s vaccine. As per the report, one of the cases has been fatal. The officials from Johnson & Johnson have said that the firm has been working with the regulators to gather more data and new findings that can help health care providers to track more risks linked to the vaccine. They have said that blood clotting and low blood platelet count have been linked to all COVID19 vaccines so far.

The officials of the company have claimed their data of close tracking of side effects have shown that only a small number of people might be identified with such side effects after vaccination. Currently, no link has been found between these rare cases of blood clotting and the Johnson & Johnson COVID19 shot. The EMA’s Pharmacovigilance Risk Assessment Committee has said that all reports indicate a safety signal, however, there is no data to prove a causal relationship between the vaccine and these rare cases. Soon, the committee will decide whether there is a need for any regulatory actions such as a warning about side effects of the single-dose vaccine. As of now, the FDA has shared the data of the US reports with the EMA to investigate the vaccine and its safety profile.

The FDA has said that the agency is looking at the safety profile of other COVID19 vaccines as well. Health officials hope that soon they will find specific safety concerns that might occur after the COVID19 vaccination and give an update as soon as possible. The US Centers for Disease Control and Prevention (CDC) has said that since the Johnson & Johnson COVID19 vaccine has been approved in the US, nearly 6.5 million doses have been given to the people. Europe has authorized the Johnson & Johnson COVID19 vaccine last month itself; however, the rollout has not started yet.

The rollout of the Johnson and Johnson COVID19 vaccine has gone into other snags in the US amid the concerns around rare blood clotting side effects. As per the report, only 700000 doses are scheduled to be shipped this week, while multiple vaccination sites have been shut down after recipients have started reporting negative reactions to the Johnson & Johnson shots. Apart from that, Johnson & Johnson is not able to live up to its prior commitment to deliver around 24 million doses by the end of this month.  When it has become public that the manufacturing partner of Johnson & Johnson, Emergent BioSolutions has spoiled a large consignment of the vaccine, the company has promised that it will work with the US officials to deliver 24 million doses by the end of April. As per the report, the firm is expected to deliver around 100 million doses of the vaccine by the end of May.

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