WHO Decision on AstraZeneca COVID-19 Vaccine Expected Next Week, Chinese Vaccine Decision in Advanced Stage
Dr Mariângela Simão, WHO Assistant-Director of Access to Medicines and Health Products.

The World Health Organization (WHO) expects to make a decision next week on whether to issue emergency use licenses for the AstraZeneca/Oxford COVID-19 vaccine being produced by the Serum Institute of India (SII) and South Korea’s SK Bioscience on 15 February, according to Dr Mariangela Simão, the organisation’s assistant director general of Drug Access, Vaccines and Pharmaceuticals.

The WHO had only received the full dossier from SII on 15 January, and the SK Bioscience dossier last week, Simao told the biweekly WHO COVID-19 press conference on Friday.

Meanwhile, the two Chinese vaccine manufacturers, Sinopharm and Sinovac, both have COVID-19 vaccines in very advanced stages of WHO’s Emergency Use Listing process, with a decision expected in early March. 

“We have a team of inspectors in China since the second week of January. They are waiting for their quarantine to finish and then they will start inspections next week,” said Dr Simão.

Sinopharm’s full dossier has been accepted for review, while WHO is expecting additional data from Sinovac today and again at the end of February. 

Of the two vaccines, Sinopharm yielded efficacy results between 79.3% and 86% in Phase 3 multi-country trials and has been approved in China for general public use. But Sinovac, on the other hand, yielded wildly varied efficacy scores ranging from 50.3% – 91.3%.

Sinovac applied for conditional approval in China on Wednesday and said that the preliminary results showed an “efficacy rate [that] meets the standards of the WHO and the guiding principles for Clinical Evaluation on Preventive COVID-19 Vaccine (tentative) issued by the NMPA [National Medical Products Administration, China’s medicines regulatory agency].” 

Companies Can Issue Voluntary Licenses to Speed Up Manufacture, Says Tedros

However, the WHO is concerned that vaccine supply is still lagging way below demand and Director General Dr Tedros Adhanom Ghebreyesus urged companies and countries to use the options available to increase manufacturing capacity, particularly as 130 countries have not yet started vaccinations.

“Countries are ready to go. But the vaccines aren’t there,” said Dr Tedros. “We need countries to share those once they have finished vaccinating health workers and older people. But we also need a massive scale up in production.”

He praised last week’s announcement by Sanofi that it would make its manufacturing infrastructure available to support production of the Pfizer/ BioNtech vaccine. 

Dr Tedros Adhanom Ghebreyesus, WHO Director General, at the press briefing on Friday.

“We call on other companies to follow this example. Companies can also issue non-exclusive licences to allow other producers to manufacture their vaccine, a mechanism that has been used before to expand access to treatments for HIV and hepatitis C. The COVID-19 technology access pool or C-TAP enables the voluntary licencing of technologies in a non exclusive, and transparent way by providing a platform for developers to share knowledge, intellectual property and data,” said Tedros, stressing that this would help to build additional manufacturing capacity in Africa, Asia and Latin America.

Meanwhile, WHO Chief Scientist Dr Soumya Swaminathan said that one of the top research priorities was whether different vaccines could be combined – for example, the Pfizer and Moderna vaccines that are both mRNA two-dose vaccines, or  “even more interesting would be to combine two different platforms so inactivated vaccine followed by an mRNA spike protein”.

“Information about vaccines both from the rollouts that are happening now in countries and observational studies, but also more randomised clinical trials are going to be needed to look at questions like the duration, and the gap between doses, as well as the combining different vaccines,” said Swaminathan, indicating that the Coalition for Epidemic Preparedness (CEPI) had already issued a call for applications from researchers to examine these questions.

Dr Soumya Swaminathan, WHO Chief Scientist.

The WHO officials welcomed the fact that the new infections were reducing in many parts of the world, but Dr Maria Van Kerkhove, COVID-19 technical lead, said this could not be ascribed to vaccine rollouts alone.

The decline was “due to a combination of factors, most notably the public health and social measures” such as active case finding, using rapid antigen-based tests, isolation of cases, and good clinical care.

“What is really critical is that countries that are reducing transmission continue to take all measures they can to drive down transmission,” stressed Van Kerkhove. “Individuals have a role to play in this, with physical distancing that must continue, the wearing of masks, making sure that you open windows, you avoid crowded spaces. All of these actions are driving down transmission.”

In regard to the push for the anti-parasitic drug ivermectin to be repurposed for treating COVID-19, Van Kerkhove said that the WHO “haven’t made a recommendation on the use of ivermectin, but we’re closely following the research that is ongoing related to this drug, which has shown some promising results in some trials for the treatment of COVID-19.”

However, Swainathan said that ivermectin had not been prioritised for inclusion in the solidarity trial, which fastracks potential treatments and warned that small studies were open to misinterpretation. 

China Joins COVAX, Commits To Supply Vaccines to LMIC Countries

In another move to “make vaccines a global public good,” China has officially joined the COVAX Facility, a WHO co-led mechanism to ensure the equitable distribution of COVID-19 vaccines, and has committed 10 million doses of vaccines to low- and middle-income countries, China’s Foreign Ministry Spokesperson, Wang Wenbin, announced on Wednesday. 

We attach great importance to Director-General Tedros’ call to vaccinate priority populations in all nations within the first 100 days of this year,” said Wang Wenbin. “We also attach great importance to the difficulties facing the practical implementation of COVAX, in particular the huge vaccine supply gap in February and March.”

It has not yet been revealed exactly which Chinese-developed vaccines are committed to COVAX and the prices of the vaccines are currently unclear, but China pledges to “offer its vaccines at fair and reasonable prices,” said the Foreign Ministry Spokesperson. 

Over 24 countries have signed vaccine deals with Sinopharm and Sinovac so far, most of them low- and middle-income countries. Most recently, China decided to donate 100,000 doses of a Chinese-developed vaccine to the Republic of the Congo and to forgive US$13 million in public debt.

Sinopharm and Sinovac vaccines have already been exported to countries that have authorized the vaccines for emergency use, including the United Arab Emirates, Indonesia, Turkey, and Brazil. 

China is currently providing vaccine aid to 13 developing countries, including Pakistan, Palestine, Sierra Leone, Zimbabwe, Myanmar, and Brunei, according to Wang Wenbin. And the country plans to assist another 38 developing countries with vaccines.

China is also encouraging domestic vaccine companies to conduct joint vaccine R&D and production with foreign partners, an effort which is encouraged by WHO.

Decision on Olympics Will Be Made With Correct Data

Responding to Japan’s declaration that the Olympic Games would go ahead later this year, Dr Michael Ryan, executive director of Health Emergencies, said that  “there is a collective desire around the world to move ahead with the Olympics” as it is  “a massive, important symbol of unity and solidarity around the world”. 

Dr Mike Ryan, WHO Executive Director of Health Emergencies Programme.

“What I do know is that the government of Japan, the organising city of Tokyo, and the International Olympic Committee have been working diligently together,” said Ryan. “And I’m absolutely sure that they’re taking every ounce of data into consideration as they move towards the Olympics. We work with them. We input to their taskforce on risk management. We will continue to do so. 

“The desire to have the games is a laudable desire, and the will to move forward is laudable as well. But I am sure, the government of Japan will take all of their data into account as they move towards the games and they will make the correct decision on behalf of the people of Japan, the athletes and potential spectators.”

Image Credits: Sinopharm, WHO.

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