Coronavirus Vaccines

WHO plans slew of approvals for global distribution of shots

Expedited authorisations crucial for poorer countries with limited regulatory capacity

Workers in Dhaka unloading AstraZeneca Covid-19 vaccines which had arrived from India as a gift to Bangladesh yesterday. Covax, a global scheme co-led by the World Health Organisation, wants to deliver at least two billion Covid-19 vaccine doses acro
Workers in Dhaka unloading AstraZeneca Covid-19 vaccines which had arrived from India as a gift to Bangladesh yesterday. Covax, a global scheme co-led by the World Health Organisation, wants to deliver at least two billion Covid-19 vaccine doses across the world this year, with at least 1.3 billion going to poorer countries.PHOTO: REUTERS

BRUSSELS • The World Health Organisation (WHO) plans to approve several Covid-19 vaccines from Western and Chinese manufacturers in the coming weeks and months, a document published on Wednesday shows, as it aims for rapid roll-outs in poorer countries.

Covax, a global scheme co-led by the WHO, wants to deliver at least two billion vaccine doses across the world this year, with at least 1.3 billion going to poorer countries.

But it has so far struggled to secure enough shots due to a shortage of funds, while wealthy nations have booked large volumes of vaccines for themselves.

In the race to deploy shots, regulatory approvals are key to confirming the effectiveness and safety of vaccines, and boosting output. But some poorer countries rely mostly on WHO authorisations as they have limited regulatory capacity.

The WHO is, therefore, expediting emergency approvals, according to a Covax internal document seen by Reuters.

The Covid-19 vaccine developed by AstraZeneca and manufactured by the Serum Institute of India (SII) could be authorised by this month or next month, the document said.

The same vaccine produced in South Korea by SK Bioscience could be approved by the second half of next month, a provisional calendar published by the WHO showed.

AstraZeneca did not respond to requests for comment, while SK said it was not aware of the WHO's approval timeline.

The AstraZeneca vaccine, developed with Oxford University, has already been given emergency approval in Britain.

Covax has supply contracts with AstraZeneca and SII for about 400 million doses and an option for hundreds of millions more.

The WHO authorised the vaccine developed by Pfizer and BioNTech at the end of last month.

It is seeking a supply deal with the US pharmaceutical giant, which has already committed hundreds of millions of doses this year to several wealthy nations.

Covax had not initially included the Pfizer-BioNTech shot in its shortlist for advance purchases.

Pfizer did not respond as to whether a deal was close and whether it would involve only a limited number of doses this year.

The provisional approval calendar also showed that the WHO is expected to approve Moderna's vaccine, which is based on the same messenger RNA technology as Pfizer's, at the end of next month.

Moderna, whose vaccine is already approved in many Western countries, including the United States and in the European Union, had no immediate comment.

The vaccine developed by Johnson & Johnson (J&J), which has a non-binding agreement to supply Covax with 500 million doses over an unspecified time frame, is expected to get WHO approval in May or June at the earliest, the WHO document said.

J&J has not yet published results of its vaccine's phase three clinical trials, but the EU has said it expects the company to apply for approval as early as next month. J&J did not respond to a request for comment.

The WHO is also considering possible quick approvals for two Chinese vaccines, the provisional calendar showed.

Sinopharm and Sinovac have filed their applications with the WHO, which is reviewing them, and could make decisions on both in March at the earliest, it said.

Neither vaccine was shortlisted by the WHO for possible advance purchase deals.

WHO approval does not automatically lead to purchases by Covax. It could also facilitate the roll-out in poorer countries that acquire the vaccines directly.

Sinopharm has filed applications for two Covid-19 vaccines, but the possible March approval concerns only the one developed by its Beijing-based affiliate, Beijing Institute of Biological Products, which has already been widely used for inoculations in China.

Sinovac has yet to release global results of its phase three trials, but its vaccine has been approved for emergency use in countries such as Brazil, Indonesia and Turkey.

Sinopharm and Sinovac did not respond to requests for comment.

REUTERS

A version of this article appeared in the print edition of The Straits Times on January 22, 2021, with the headline 'WHO plans slew of approvals for global distribution of shots'. Subscribe