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WHO approves Johnson & Johnson COVID vaccine for use

WHO approves Johnson & Johnson COVID vaccine for use
March 13
00:24 2021

The World Health Organisation (WHO), on Friday, listed the Johnson & Johnson COVID-19 vaccine for emergency use in all countries.

The approval brings to three the number of vaccines that have received backing from the WHO — the organisation had earlier approved the Pfizer/BioNTech and Oxford/AstraZeneca vaccines.

In December 2020, Johnson & Johnson had announced it had enrolled about 45,000 participants for the first late-stage trial of its COVID-19 single-dose vaccine, and that it expects interim data by January.

After the successful trial of the vaccine, it was found to be over 60 percent effective in preventing COVID-19 in multiple variants of the virus.

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The drugmaker later submitted data to the WHO on February 19, for emergency use listing of its vaccine.

According to a statement issued on Friday, WHO said the decision to approve the vaccine comes after the European Medicines Agency (EMA) authorisation, which was announced on Thursday.

TheCable had reported that the EU medicines regulator authorised the Johnson & Johnson single-dose vaccine for use across the European Union.

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Speaking on the approval, Tedros Ghebreyesus, director-general of WHO, said “every new, safe and effective tool against COVID-19 is another step closer to controlling the pandemic”.

“I urge governments and companies to live up to their commitments and to use all solutions at their disposal to ramp up production, so that these tools become truly global public goods, available and affordable to all, and a shared solution to the global crisis,” Ghebreyesus was quoted to have said.

According to the WHO statement, the vaccine is the first to be listed by the organisation as a single-dose regimen, which should facilitate vaccination logistics in all countries.

It added that “the ample data from large clinical trials shared by the company also shows that the vaccine is effective in older populations”.

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“To expedite listing of the vaccine, WHO and a team of assessors from all regions adopted what is called an ‘abbreviated assessment’ based on outcomes of the EMA review, and evaluation of quality, safety and efficacy data focused on low- and middle-income country needs,” the statement reads.

WHO added that as part of the emergency use listing process “the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine.”

The WHO also noted that the COVAX facility has booked 500 million doses of the vaccine.

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