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Friday, April 26, 2024

Sinopharm gets ‘green light’ for emergency use

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The World Health Organization approved Friday the Sinopharm COVID-19 vaccine for emergency use—the first Chinese jab to receive the WHO's green light.

The UN health agency signed off on the two-dose vaccine, already being deployed in dozens of countries around the world.

The WHO has given emergency use listing to the vaccines being made by Pfizer-BioNTech, Moderna, Johnson and Johnson, and the AstraZeneca jab being produced at sites in India and in South Korea, which it counts separately.

Meanwhile, the delivery and roll-out of the Moderna COVID-19 mRNA Vaccine in the Philippines can now proceed after the Food and Drug Administration (FDA) approved its application for Emergency Use Authorization (EUA), according to Zuellig Pharma Corporation.

Also, vaccine confidence among Filipinos has increased to nearly 75 percent,  about a month since the Philippines began its inoculation program against COVID-19, the  Department of Health said.

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"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 Immunisation, 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.

An EUA would allow a vaccine under development to be used for the government vaccination program.

Health Secretary Francisco Duque III had ordered his agency to file an emergency use clearance for the Chinese state firm's COVID-19 vaccine.

It is the first vaccine developed by a non-Western country to win WHO support.

Duterte got vaccinated with Sinopharm in early May even without emergency clearance.

His aides had said he was covered by the compassionate special permit for the vaccine, which was last year granted on the Sinopharm vaccines used by the Presidential Security Group.

Vaccine czar Secretary Carlito Galvez Jr. said Thursday from an initial target of 148 million, the Philippines was now aiming to acquire 202 million COVID-19 vaccine doses, 

At a televised briefing, Galvez said the country now aimed to purchase 158 million doses and receive another 44 million doses from the global vaccine-sharing facility COVAX.

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, the 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 AstraZeneca and some Pfizer jabs are flowing through the scheme. 

Bruce Aylward, the 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 hospitalised 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 (166), Pfizer-BioNTech (94), and Moderna (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.

2nd 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 the WHO was still analysing 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".

Moderna gets EUA

Zuellig Pharma Corporation, through its commercialization division ZP Therapeutics, is the emergency use authorization holder and services provider of COVID-19 Vaccine Moderna for the Philippines.

In the announcement of the issuance of Moderna’s EUA, FDA Director General Eric Domingo said, “It is decided that all conditions for an EUA are present and that the benefit of using the vaccine outweighs the known potential risks.”

“With this approval, we will be able to add another ammunition in the country’s battle against the coronavirus,” said Raymund Azurin, Senior Vice President for Government Affairs and Sustainability, Zuellig Pharma Corporation.

Vaccine confidence

Vaccine confidence among Filipinos has increased to nearly 75 percent, about a month since the Philippines began its inoculation program against COVID-19, the  Department of Health said.

In an online press briefing, Health Undersecretary Maria Rosario Vergeire said this was based on a survey on willingness to get vaccinated, conducted from March 19 to March 30 among an undisclosed number of respondents.

Around 75 percent responded in the affirmative when asked if they would be willing to be vaccinated, Vergeire said.

"The confidence of our countrymen in vaccines has improved compared to the initial trust figures which was just at 65 percent,” Vergeire said.

Almost  86 percent of respondents said they believed that COVID-19 jabs were "safe and efficacious," she said.

May procurement

Galvez said that the country expected to increase its vaccine inventory substantially in the second quarter.

"In the first quarter, the vaccines were coming in trickles. Now, they're coming in millions," he said.

From the figures of just four million vaccine doses in total from February to April, it has now already received 3,753,450 doses in May so far.

This consists of:

-30,000 Sputnik V doses from Russian manufacturer Gamaleya Institute

-1,500,000 Sinovac doses purchased by the government

-2 million AstraZeneca doses from the COVAX facility

-193,050 Pfizer-BioNTech doses from the COVAX facility

It is expecting to receive 7,753,450 doses in total this month.

This includes 2.2 million doses of the Pfizer-BioNTech vaccine from COVAX—almost double the amount the Philippines was initially set to receive for this month.

June procurement

The government is also expecting to receive 10.05 million vaccine doses in June.

This consists of:

-2 million AstraZeneca doses to go to LGUs to be administered as a second dose

-1.3 million AstraZeneca doses for the private sector the first shipment of Moderna vaccines to the country, consisting of -250,000 doses

-4.5 million Sinovac doses, including 500,000 for the Federation of Filipino-Chinese Chamber of Commerce and Industry Inc.

-2 million Sputnik V doses. With AFP

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