The Medicines and Healthcare products Regulatory Agency (MHRA) announced Friday that Johnson & Johnson's COVID-19 vaccine Ad26.COV2.S has been authorised in the UK and also endorsed by the country's independent Commission on Human Medicines. UK Health Secretary Matt Hancock said the single-dose vaccine "will play an important role in the months to come as we redouble our efforts to encourage everyone to get their jabs and potentially begin a booster programme later this year."
Data from the Phase III ENSEMBLE study has shown Ad26.COV2.S to be about 67% effective overall in preventing COVID-19 infection and 85% effective in preventing severe disease or hospitalisation. The vaccine is similar to AstraZeneca's Vaxzevria in that it uses a viral vector, and there has been concern about both being linked to rare, but serious cases of blood clots with low platelets. Still, regulators in the US and EU have said the benefits of receiving them outweigh the risks.
MHRA head June Raine stated that the agency had thoroughly vetted the quality, safety and effectiveness of Ad26.COV2.S, adding "we now have four safe and effective vaccines approved to help protect us from COVID-19." The other three currently authorised in the UK are Vaxzevria, as well as Pfizer/BioNTech's Comirnaty and Moderna's mRNA-1273, both of which are based on mRNA technology.
The UK's Vaccine Taskforce originally secured 30 million doses of Johnson & Johnson's vaccine last year, although the government has now lowered its order to 20 million doses given the "unprecedented scale and pace" of the country's immunisation programme. The vaccine can also be stored at normal fridge temperatures of between 2 and 8 degrees Celsius, which the MHRA said makes it "ideal for distribution to care homes and other locations." It added that first deliveries are expected to arrive later this year, but before they become available, the UK's Joint Committee on Vaccination and Immunisation (JCVI) will produce advice on exactly who should receive it.
Meanwhile, Ad26.COV2.S is part of the Cov-Boost study to assess its safety and effectiveness as the third dose of a potential booster programme, while Johnson & Johnson continues to explore a two-dose regimen as well. The vaccine has already been authorised for use in the EU and US, and has also received an emergency-use listing by the World Health Organization.
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