Gov’t hopes confidence in Chinese jab will increase
THE World Health Organization yesterday said it has approved a COVID-19 vaccine made by Sinovac Biotech for emergency use listing, paving the way for a second Chinese shot to be used in poor countries.
A WHO emergency listing is a signal to national regulators of a product’s safety and efficacy and will allow the Sinovac shot to be included in the COVAX Facility, the global program providing vaccines mainly for poor countries, which faces major supply problems due to curbs on Indian exports.
The Philippines is among recipients of COVAX vaccines.
Malacañang and the Department of Health hoped the development will boost public confidence in the China-made vaccine. A recent survey showed Filipinos prefer vaccines made by western firms.
The WHO approval is seen to also benefit seafarers and other Filipinos working overseas, amid reports that Saudi Arabia and the European Union have barred travelers who have been vaccinated with Chinese vaccines, including Sinovac.
More than half of the Philippines’ vaccine supply so far has come from Sinovac, a private Chinese firm.
Hours after the WHO announcement, President Duterte appeared in a video urging the public to get vaccinated at the earliest possible time.
The one-minute, 39-second video “Kasangga natin ang Pangulong Duterte sa pag-Resbakuna” ad was posted on the Facebook page of the Department of Health.
“I invite all our kababayans to be vaccinated at the earliest possible opportunity because this is the most, if not the only way, effective way, to defeat COVID-19 pandemic. Let us all keep in mind that the vaccine will not only protect you from the virus, it will also protect your loved ones, especially the sick and elderly,” Duterte said in his message.
“Your participation in the ‘Resbakuna: Kasangga ng BIDA’ campaign is therefore key if we are to reopen our economy and reclaim our normal lives. To the Filipino people, let me assure you that the government will continue to do its best to protect you until we overcome this health crisis together. Let us heal as one nation. Kapwa Pilipino, magpabakuna na po tayo,” he added.
The government has received 5.5 million doses of Sinovac vaccines since February, including a million doses donated by the Chinese government. The Philippines is buying a total of 25 million doses, with 4.5 million doses expected this month.
Five of seven vaccine brands in the Philippine vaccine portfolio are in the WHO’s emergency use listing (EUL) namely: Pfizer-BioNTech, AstraZeneca, Johnson & Johnson/Janssen, Moderna, and Sinovac.
The government started the national vaccination program on March 1.
The WHO’s independent panel of experts said in a statement it recommended Sinovac’s vaccine for adults over 18. There was no upper age limit as data suggested it is likely to have a protective effect in older people.
Branded CoronaVac in some regions, the Sinovac vaccine is the eighth to win such a WHO listing to combat COVID-19 and the second developed by a Chinese company, after the May 7 approval of a shot developed by state-backed Sinopharm.
While a third Chinese vaccine, produced by CanSino Biologics , has submitted clinical trial data, no WHO review has been scheduled.
Sinovac said that it had supplied more than 600 million doses of its vaccine at home and abroad as of end-May and over 430 million doses have been administered.
The endorsement is a big boost for Sinovac’s vaccine after data in clinical trials showed a wide range of efficacy rates.
The WHO’s technical advisory group, which began meeting on May 5, made the decision after reviewing the latest clinical data on the Sinovac vaccine’s safety and efficacy as well as the company’s manufacturing practices.
WHO Director General Tedros Adhanom Ghebreyesus welcomed the move, calling the vaccine safe and effective and noting its easy storage requirements make it suitable for low-income countries.
“It’s now crucial to get these lifesaving tools to the people that need them quickly,” he told a briefing.
The WHO said results showed it prevented symptomatic disease in 51% of those vaccinated and prevented severe COVID-19 and hospitalization in 100% of the studied population.
The WHO’s separate Strategic Advisory Group of Experts (SAGE) had said previously that vaccine efficacy in multi-country Phase III clinical trials ranged from 51% to 84%.
Indonesia said on May 12 that its study of 120,000 healthcare workers who had received the vaccine found it was 94% effective at preventing symptomatic disease.
In a preliminary evaluation, the SAGE panel found that the shot was effective in preventing COVID-19 in adults under 60, but that some quality data on the risk of serious adverse effects was lacking.
It cited evidence gaps in safety in pregnancy, and on safety and clinical protection in older adults, those with underlying disease, and evaluation of rare adverse events.
SAGE experts, who issue policy recommendations to states and dosage guidelines, reviewed Sinovac clinical data last month.
Sinovac chairman and chief executive Weidong Yin said in a statement that clinical trials had provided a “solid scientific foundation” for the drug maker’s shot to be approved by more than 40 countries and by the WHO.
China has already deployed hundreds of millions of doses of both Sinopharm and Sinovac vaccines at home and exported them to many countries, particularly in Africa, Asia and Latin America.
Vaccine czar Carlito Galvez Jr., chief of the National Task Force against COVID-19 (NTF), NTF consultant Dr Ted Herbosa, and presidential spokesman Harry Roque expressed hope the WHO approval will boost public confidence in the Sinovac vaccine.
“This is a major boost not just in our vaccine rollout and in our efforts to address vaccine hesitancy among many Filipinos, particularly our senior citizens,” Galvez said, adding that the emergency use listing (EUL) is a “strong testament that the vaccines procured by the government are all safe and effective.”
Only 14.5 percent of the senior citizen population and 25.29 percent of the targeted number of individuals with comorbidities have so far been inoculated.
Galvez, in an interview with ANC, said the listing of Sinovac should also make it easier for Filipinos overseas and seafarers to be vaccinated with any brand, following earlier concerns that they will not be allowed entry to some countries that prefer western vaccines.
He said the EUL would also enable Sinovac to contribute to the COVAX Facility and eventually increase the supply that is being given to the poor and developing countries.
“Lalaki ang supply ng COVAX at the same time, iyung ating mga OFW and seafarers ay hindi na mag-aalala as all countries should recognize the vaccines under EUL of WHO, given that it is the highest level of stringent regulatory authority (The COVAX supply will increase at the same time, the OFW and seafarers will no longer worry as all countries should recognize the vaccines under EUL of WHO, given that it is the highest level of stringent regulatory authority),” Galvez said.
Herbosa, during the “Laging Handa” public briefing, said the EUL listing shows that Sinovac is comparable to the vaccines from Pfizer, AstraZeneca, Moderna, Johnson & Johnson and Sinopharm.
Health Undersecretary Maria Rosario Vergeire said they expect other countries to honor a mutual recognition agreement regarding drug regulatory processes after the WHO approval. — With Gerard Naval and Reuters
