The World Health Organization (WHO) plans to approve several COVID-19 vaccines from Western and Chinese manufacturers in the coming weeks and months, according to a document published on Wednesday, as the World Health Agency aims for rapid release of vaccines in poorer countries .
COVAX, a global scheme led by the WHO, wants to deliver at least two billion COVID-19 doses worldwide this year, with at least 1.3 billion to poorer countries.
But the facility has so far struggled to get enough shots due to a shortage of funds, while affluent countries have booked large amounts of vaccinations for themselves.
In the race to introduce vaccines, key approvals are the key to confirming the efficacy and safety of vaccines and to increase production. But some poorer countries mostly rely on WHO authority because they have limited regulatory capacity.
The WHO is thus accelerating emergency permits, according to an internal document from COVAX seen by the Reuters news agency.
The document states that the COVID-19 vaccine developed by AstraZeneca and manufactured by the Serum Institute of India (SII) is authorized.
The same vaccine, produced by SK Bioscience in South Korea, could be approved by the UN agency in early second half of February, according to a preliminary calendar published by the WHO.
In addition to vaccines, regulators usually authorize their manufacturing processes in different plants.
AdII Poonawalla, CEO of SII, told Reuters last week that he expected the approval of the WHO “in the next week or two”.
AstraZeneca did not respond to requests for comment, while SK Bioscience said it was not aware of the WTO approval timeline.
The AstraZeneca vaccine, developed with the University of Oxford, has already been approved in the UK, while decisions in the European Union and the United States are imminent.
COVAX has contracts with AstraZeneca and SII for approximately 400 million doses and an option for many hundreds of millions more, although the time of delivery is uncertain.
Other Western shots
The WHO approved the vaccine developed by Pfizer and its German partner BioNTech at the end of December.
WHO officials have said they want to seek a supply deal with the US pharmaceutical giant, which has already committed hundreds of millions of doses to several affluent countries this year.
COVAX initially did not include the Pfizer / BioNTech survey in its pre-purchase shortlist.
Pfizer has not responded to a request for comment on whether an agreement has been reached and whether it will involve only a limited amount of doses this year.
The preliminary approval calendar also indicates that the WHO is expected to approve Moderna’s COVID-19 vaccine, which is based on the same messenger RNA (mRNA) technology as Pfizer, at the end of February.
Moderna, whose vaccine has already been 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 deliver 500 million doses to COVAX over an unspecified time frame, is expected to be approved by the WTO in early May or June, according to the WHO document.
J&J has not yet published the results of the Phase III clinical trials of its vaccine, but the EU has said it expects the company to apply for approval as early as February.
A J&J spokesman did not respond to a request for comment.
China and Russia
The WHO is also considering possible rapid approvals for two Chinese vaccines, the preliminary calendar shows.
Sinopharm and Sinovac have submitted their applications to the WHO, which will review them and take decisions at the earliest in March, it said.
None of the vaccines have been shortlisted by the WHO for possible pre-purchase contracts. WHO approval does not automatically lead to purchases by COVAX. It can also facilitate the release in poorer countries that obtain the vaccines directly.
Sinopharm has submitted applications for two COVID-19 vaccines, but the possible approval in March only applies to the one developed by its Beijing-based subsidiary, Beijing Institute of Biological Products Co., Ltd. (BIBP), which has already been widely used. for vaccinations in China.
Sinovac has not yet announced worldwide 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 preliminary timetable for the possible approval of the Russian Sputnik V vaccine, although the developers have submitted the relevant documentation, it appears from the timetable.
The Russian Direct Investment Fund (RDIF), the main financial backing of Sputnik V, did not respond to a request for comment.