WHO approves China’s Sinopharm vaccine
The World Health Organization (WHO) on Friday approved the Sinopharm COVID-19 vaccine for emergency use – the first Chinese jab to receive WHO’s green light.
The UN health agency signed off on the two-dose vaccine, which is already being deployed in dozens of countries around the world.
The WHO has already given emergency use listing (EUL) to the vaccines being made by Pfizer-BioNTech, Moderna, Johnson & Johnson and the AstraZeneca jab being produced at sites in India and in South Korea, which it counts separately.
“This afternoon, WHO gave emergency use listing to Sinopharm Beijing’s COVID-19 vaccine, making it the sixth vaccine to receive WHO validation for safety, efficacy and quality,” WHO chief Tedros Adhanom Ghebreyesus
told a news conference.
“The Strategic Advisory Group of Experts on Immunization, or SAGE, has also reviewed the available data and recommends the vaccine for adults 18 years and older, with a two-dose schedule.”
An emergency use listing by the WHO paves the way for countries worldwide to quickly approve and import a vaccine for distribution, especially those states without an international-standard regulator of their own.
It also opens the door for the jabs to enter the COVAX global vaccine-sharing scheme, which aims to provide equitable access to doses around the world and particularly in poorer countries.
COVAX call
“The addition of this vaccine has the potential to rapidly accelerate COVID-19 vaccine access for countries seeking to protect health workers and populations at risk,” said Mariangela Simao, WHO’s assistant director general for access to health products.
“We urge the manufacturer to participate in the COVAX Facility and contribute to the goal of more equitable vaccine distribution.”
Currently, only Astra
Zeneca and some Pfizer jabs are flowing through on the scheme.
Bruce Aylward, WHO lead on COVAX, said Sinopharm was looking at trying to provide substantial support, make substantial doses available.
“It has been very interested in looking at playing a role to help with the global response, which is encouraging.”
The WHO recommended that the two Sinopharm shots be taken three to four weeks apart.
The vaccine’s efficacy for symptomatic and hospitalized cases of COVID-19 was estimated to be 79 percent when all age groups are combined, it said.
The agency said few adults over 60 were enrolled in clinical trials of the vaccine, so its efficacy could not be estimated in that age group.
Nevertheless, “there is no theoretical reason to believe that the vaccine has a different safety profile in older and younger populations,” it said.
The Sinopharm vaccine is already in use in 42 territories around the world, fourth behind AstraZeneca with 166, Pfizer-BioNTech at 94 and Moderna with 46, according to an AFP tally.
Besides China, it is being used in Algeria, Cameroon, Egypt, Hungary, Iraq, Iran,
Pakistan, Peru, the United Arab Emirates, Serbia and the Seychelles, among others.
Second Chinese vaccine next
A clutch of other vaccines are on the road towards WHO emergency use listing.
A WHO decision is expected within days on Sinovac, a second Chinese-made vaccine already being used in 22 territories.
But WHO experts said Friday they have now asked Sinovac for additional information and are waiting for answers before they can make a recommendation.
Behind Sinovac, Russia’s Sputnik V vaccine is the next furthest ahead in the process.
But Simao said WHO was still analyzing data, receiving additional information on the dossier and conducting site inspections that will end in the first week of June.
Approving Sputnik V could happen after that, she said, “but it depends on the inspections being made and the dossiers being completed.”
Rody’s second jab
Sinopharm’s WHO approval came just days after President Duterte ordered the return of 1,000 doses of the vaccine – part of a planned 10,000 doses donated by the Chinese government – back to
China, citing a lack of endorsement of its safety and efficacy from the country’s Food and Drug Administration (FDA).
The President received his first Sinopharm jab last week under an earlier compassionate use permit granted by the FDA to the Presidential Security Group (PSG) – a move that did not sit well with various sectors as the vaccine, at the time, was not approved by the WHO for emergency use yet, and currently does not have an emergency use authorization (EUA) from the FDA.
As a result of the negative reactions to his inoculation, Duterte apologized and ordered the return of the vaccine to China.
After Friday’s developments, however, the President may get Sinopharm’s vaccine as his second dose after all.
Health Secretary Francisco Duque III yesterday confirmed this possibility after news of WHO’s emergency use listing for the vaccine and, in view of this, he said the Department of Health (DOH) will file an application for EUA for Sinopharm with the FDA.
“I have already instructed the Bureau of Public Health Service Office of DOH to file with FDA for issuance of EUA for the Sinopharm donated vaccine,” he noted at a press briefing.
The health chief added as soon as an EUA is issued, the DOH will recommend to the President that the vaccine “no longer be returned to China.”
Asked if there is a possibility that Duterte will again receive a Sinopharm jab as his second dose, Duque replied, “Yes, definitely.”