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BRUSSELS – The World Health Organization (WHO) plans to approve several COVID-19 vaccines from Western and Chinese manufacturers in the coming weeks and months, a document released on Wednesday shows, as it points to rapid rollouts in poorer countries.
COVAX, a global scheme co-led by WHO, wants to deliver at least 2 billion doses of COVID-19 worldwide this year, with at least 1.3 billion for the poorest countries.
But so far it has struggled to secure enough vaccines due to funding shortfalls, while wealthy nations have reserved large volumes of vaccines for themselves.
In the race to implement vaccines, regulatory approvals are key to confirming the effectiveness and safety of vaccines and to boosting production. But some poorer countries rely mainly on WHO authorizations, as they have limited regulatory capacity.
The WHO is therefore “speeding up” emergency approvals, according to an internal COVAX document seen by Reuters.
The COVID-19 vaccine developed by AstraZeneca and manufactured by the Serum Institute of India (SII) could be licensed by the WHO in January or February, the document says.
The same vaccine produced in South Korea by SK Bioscience could be approved by the UN agency in the second half of February at the earliest, according to a provisional schedule published by the WHO on Wednesday.
In addition to vaccines, regulators often authorize their manufacturing processes at different plants.
SII executive director Adar Poonawalla told Reuters last week that he expected WHO approval “in the next week or two.”
AstraZeneca did not respond to requests for comment, while SK said it was not aware of the WHO approval schedule.
The AstraZeneca vaccine, developed with the University of Oxford, has already received emergency approval in Britain, while decisions in the European Union and the United States are close.
COVAX has supply contracts with AstraZeneca and SII for around 400 million doses and an option for many more hundreds of millions, although the timing of deliveries is uncertain.
OTHER WESTERN TAKES
The WHO licensed the vaccine developed by Pfizer and its German partner BioNTech in late December.
WHO officials have said they are seeking a supply deal with the US pharmaceutical giant, which has already pledged hundreds of millions of doses this year in several wealthy nations.
COVAX had not initially included the Pfizer / BioNTech outlet on its short list for advance purchases.
Pfizer did not respond to a request for comment on whether a deal was closed and would involve only a limited number of doses this year.
The tentative approval schedule also shows that the WHO is expected to approve Moderna’s COVID-19 vaccine, which is based on the same messenger RNA (mRNA) technology as Pfizer’s, in late February.
Moderna, whose vaccine is already approved in many Western countries, including the United States and the European Union, did not immediately 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 period of time, is expected to obtain WHO approval in May or June at the earliest, says the WHO document.
J&J has not yet released the results of phase III clinical trials of its vaccine, but the EU has said it expects the company to apply for approval starting in February.
A J&J spokesperson did not respond to a request for comment.
CHINA AND RUSSIA
The WHO is also considering possible expedited approvals for two Chinese vaccines, the tentative schedule shows.
Sinopharm and Sinovac have submitted their applications to the WHO, which is reviewing them and could make decisions on both in March at the earliest, he says.
No vaccine was shortlisted by WHO for possible advance purchase agreements. WHO approval does not automatically lead to purchases by COVAX. It could also facilitate deployment in poorer countries that purchase vaccines directly.
Sinopharm has submitted applications for two COVID-19 vaccines, but the possible approval in March refers only to the one developed by its Beijing-based subsidiary, Beijing Institute of Biological Products Co., Ltd (BIBP), which has already been widely used. for inoculations in China.
Sinovac has not yet released the global results of its phase III 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.
There is still no tentative schedule for the possible approval of Russia’s Sputnik V vaccine, despite the fact that its developers have submitted the relevant documentation, the schedule shows.
The Russian Direct Investment Fund (RDIF), the main financial sponsor of Sputnik V, did not respond to a request for comment. – Francesco Guarascio / Reuters
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