British drug regulator approves J&J vaccine

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May 28 (UPI) — Britain’s Medicines and Healthcare products Regulatory Agency on Friday approved a one-dose coronavirus vaccine produced by Johnson & Johnson.

The approval makes the Johnson & Johnson vaccine the fourth available in Britain. Vaccines by Pfizer/BioNTech, Moderna and AstraZeneca/Oxford are all available. The Johnson & Johnson vaccine, though, is the first one-dose vaccine that will be used.

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The vaccine, referred to by Johnson & Johnson’s subsidiary Janssen, will be available for those 18 and over while pregnant and breast-feeding women should talk to their doctors before using it, the MHRA said.

The Centers for Disease Control and Prevention and Food and Drug Administration paused using the Johnson & Johnson vaccine in the United States for more than a week while researching reports of blood clotting complications among a small number of users. The agencies approved the drug for use again last month.

The European Union’s top medicines regulator said last month a warning should accompany the Johnson & Johnson vaccine with information that says it has been linked to cases of blood clotting. It said in its ruling that the clotting issue appeared to be “very rare.”

“We have undertaken a thorough review of the conditional marketing authorization application submitted by Janssen, including the information on quality, safety and effectiveness,” Dr. June Raine, MHRA’s chief executive said in a statement. “This is encouraging news for the public and the healthcare sector. We now have four safe and effective vaccines approved to help protect us from COVID-19.”

Munir Pirmohamed, chair of the independent Commission on Human Medicines, said its coronavirus working group was “pleased” with the MHRA’s evaluation of Johnson & Johnson’s application and recommendation.

“This is yet another win for the vaccination program, which has saved thousands of lives so far, he said.