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US regulators recommend ‘pause’ in use of Johnson & Johnson vaccine over blood clot fears

The United States has suspended use of a coronavirus vaccine Kenya is eyeing over blood clot fears.

US regulators Centers for Disease Control and Prevention (CDC) and the Food & Drug Administration (FDA) Tuesday suspended use of the Johnson & Johnson Covid-19 vaccine after six recipients developed a rare disorder involving blood clots, within about two weeks of getting vaccinated with the single-dose jab.

The CDC and the FDA said they will stop using the drug, developed by J&J’s Janssen Pharmaceuticals division. CDC data indicates 6.8 million doses of the vaccine have been administered as of April 12.

“The CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance,” the agencies said in a joint statement.

“The FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution.”

AfricaCDC deal

Interim analysis of Phase 3 clinical trials in January showed that the vaccine was safe and effective at preventing moderate and severe Covid-19 in adults.

The vaccine, called Ad.26.COV2.S or JNJ-78436725, requires only a single injection and can be stored in a refrigerator for months. In February, the US FDA authorised for emergency use.

The pause may present a significant challenge for African countries like Kenya which are eagerly waiting for the vaccine to ramp up its vaccination programme.

The Ministry of Health recently mentioned it was in talks with the African Union (AU) to acquiring the single-dose Johnson & Johnson Covid-19 vaccine through the AfricaCDC.

Early in April, the AfricaCDC announced a deal that will see the manufacturer partner with South African based producer, Aspen Pharmacare, to supply up to 220 million doses to the 55 AU member states beginning October.

“We are pursuing J&J and are talking to AU but there are no specifics at this point,” Kenya’s Vaccine Advisory Task Force chairman Willis Akhwale had disclosed.

Investigations opened

According to The New York Times, the recipients who developed clots were six women aged between 18 and 48, representing a rate of around one in a million. One of them died and another is in hospital.

Johnson & Johnson’s vaccine – made by a Belgian subsidiary called Janssen – is one of the three vaccines being used in the US.

On Twitter, the FDA said: “We are recommending a pause in the use of this vaccine out of an abundance of caution… Right now, these adverse events appear to be extremely rare.”

The news makes the vaccine the second to become embroiled in a blood clot scare. A week ago some European countries, including the UK, stopped giving the AstraZeneca vaccine to people below the age of 30.

This followed concerns that it might increase the likelihood of a rare type of brain blood clot that can trigger strokes combined with a low platelet count (called thrombocytopenia).

As a result, the European Medicines Agency (EMA) said it had established a link between rare blood clots in the brain and the AstraZeneca jab, but noted that its benefits outweigh the risks.

The World Health Organization (WHO) also noted that based on current information, a causal relationship between the Oxford/AstraZeneca vaccine and the occurrence of blood clots with low platelets is considered plausible but is not confirmed.