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14th May 2022

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CDC considers whether to lift pause on Johnson & Johnson’s Covid-19 vaccine

Some of America’s top health scientists will meet on Friday to decide whether to endorse restarting Johnson & Johnson’s Covid-19 vaccine, following a 10-day pause it recommended due to concerns over blood clots.

The Advisory Committee on Immunization Practices will hold a six-hour meeting to determine the fate of the J&J inoculation in the US, as several other countries also grapple with whether it is safe enough for everyone to receive.

The committee met last week, but could not agree whether the single-shot vaccine should still be recommended for universal use in adults. That followed a rare joint statement by the US Centers for Disease Control and Prevention and the Food and Drug Administration urging states and healthcare providers to halt the jab after six recipients suffered serious blood-clotting issues.

The scientific advisers could recommend the vaccine be halted indefinitely, resumed for everyone or restarted just for certain sections of the population. Their finding will then go to the CDC director for approval before the Food and Drug Administration will make a final decision over whether the J&J vaccinations should restart.

Experts have debated whether there is a definite link between the jab and a rare medical condition where blood clots occur alongside low platelet counts. One problem with that condition is that the anticoagulants usually used to treat clots might make the problem worse.


7m


the number of J&J vaccinations administered in the US before the pause

Some argue that even if there is a link, the benefits of the jab outweigh the risks, given US trials have shown it to have an efficacy rate of about 66 per cent for preventing moderate or severe Covid-19.

Earlier this week the European Medicines Agency found there was a “possible link” between the jab and blood clots, but concluded the benefits outweighed the risks. Germany announced on Friday morning it would allow the vaccine to be given to everyone, but Sweden said it was keeping its suspension in place.

Since the start of the pause, the pace of inoculations in the US has dropped from an average of 3.4m a day to 2.9m a day. The country has administered 219m doses, according to the CDC, with just over half of all adults having received at least one dose.

US regulators called for the pause after six women suffered very rare but serious blood clotting issues within days of getting the vaccine, out of more than 7m who had received it. One of those women died. Experts on the ACIP said last week they did not have enough data to determine whether this was a widespread problem or one that only affected certain parts of the population.

Since then, federal agencies have reported a similar case in Texas, also involving a woman.

A similar issue with rare blood clots has disrupted the rollout of the Oxford/AstraZeneca vaccine, which, like J&J’s jab, uses an adenovirus, such as the common cold, to deliver the vaccine protein into the body. Vaccines developed by BioNTech/Pfizer and Moderna use messenger RNA technology.

J&J’s vaccine, the first single-shot jab authorised for use in the US, has faced other setbacks. Production of the vaccine at a plant in Baltimore was halted by the FDA earlier this week while the agency investigates the site, run by Emergent BioSolutions, which has been beset by manufacturing problems.

The House of Representatives committee on oversight and reform on Monday launched a separate investigation into whether Emergent received contracts to manufacture vaccines “despite a long, documented history of inadequately trained staff and quality control issues”.

2021-04-23 15:36:36


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