It’s the fourth jab to be approved in the UK.
The U.K. drugs regulator Friday backed the use of Johnson & Johnson’s single-dose COVID-19 vaccine.
The Medicines and Healthcare Products Regulatory Agency (MHRA), which has been reviewing the datasets supporting the vaccine since late February, green-lit its use in adults 18 and over. Like the Oxford/AstraZeneca vaccine, the J&J jab is an adenovirus viral vector vaccine.
It’s the fourth jab to be approved in the U.K., following BioNTech/Pfizer, Oxford/AstraZeneca and Moderna, but it’s the first single-shot vaccine to get the OK. The EU approved the vaccine on March 11.
The single-dose vaccine was shown to be 67 percent effective overall in preventing COVID-19 infection and 85 percent effective in preventing severe disease or hospitalization, the U.K. government said in a statement.
Like the Oxford/AstraZeneca vaccine, the J&J jab comes with a warning of risks of rare but serious blood clots and thrombocytopenia
In April, as the first shipments were due to arrive in Europe, the U.S. recommended suspending use of J&J’s vaccine after six reports of those blood clots. The company then promptly announced it would “proactively delay” its European rollout. The European Medicines Agency investigated eight reported cases of blood clots from the U.S. and concluded on April 20 that the vaccine’s benefits outweighed its risks, while not ruling out a link to rare clots.
Similarly, drug regulators in the EU and U.K. have said the Oxford/AstraZeneca vaccine is possibly linked to those very rare blood clots, but the EMA has not concluded there is a class effect with these types of vaccines. Belgium has restricted the use of the J&J jab to over 41s, while Denmark has dropped both the J&J jab and Oxford/AstraZeneca jabs from its program.
The U.K. has ordered 30 million doses of J&J’s vaccine, but reduced its order to 20 million Friday. The EU has secured up to 400 million doses.
J&J’s vaccine was already granted an emergency use listing from the WHO on March 12 — a prerequisite to supply vaccines to the COVAX facility for pooled procurement and distribution, especially in low-income countries. That followed the U.S. emergency-use authorization on February 27.This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email email@example.com for a complimentary trial.
Source: POLITICO https://www.politico.eu/article/uk-oks-jj-coronavirus-vaccine/?utm_source=RSS_Feed&utm_medium=RSS&utm_campaign=RSS_Syndication