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Rody picks Sinopharm; FDA chooses Sinovac

MJ Blancaflor



President Rodrigo Duterte prefers to be inoculated with the Covid-19 vaccine developed by China-owned biotech firm Sinopharm, Malacañang said Monday.

Presidential spokesperson Secretary Harry Roque disclosed the Chief Executive’s preference weeks after saying that Duterte’s choice of Covid-19 vaccine is one made by a Chinese firm — without disclosing a particular brand then.

“He has said his preference is for Sinopharm,” Roque has said during his televised briefing at the start of the week.

Sinopharm vaccine was also the jab administered last year to his security aides, even without an emergency use authorization (EUA) from the Food and Drug Administration (FDA).

The Presidential Security Group (PSG) reportedly obtained a “donation” of Sinopharm doses and administered it among themselves in September and October.

Sinopharm has neither been given an EUA by the Philippines for its Covid-19 vaccine nor it applied for such approval.

President Duterte previously said he was not aware that his security detail has been inoculated.

Sinopharm has claimed its vaccine has a 79 percent efficacy rate, based on interim Phase 3 trials.

The FDA, meanwhile, has authorized the local use of Sinovac’s Covid vaccine, paving the way for its expected delivery to the Philippines this week.

FDA director general Eric Domingo announced on Monday that the country’s regulatory board issued an EUA to the Sinovac jabs after a review of its late-stage trial data reaffirmed the shot is safe and effective with mild to moderate side effects as well as “minimal” possibility of allergy.

“After a thorough and rigorous review of the currently available published and unpublished data by our regulatory and medical experts, the FDA is granting an emergency use authorization to the Covid-19 vaccine of Sinovac Life Sciences Company, known as SARS-CoV-2 vaccine Vero Cell Inactivated or CoronaVac,” Domingo said in a televised briefing.

“The benefit of using the vaccine outweighs the known and potential risk,” he added.

Sinovac’s CoronaVac is the third Covid-19 vaccine that has received an EUA in the Philippines, following those developed by Pfizer-BioNTech and AstraZeneca.

While the FDA granted Sinovac’s vaccine emergency approval, Domingo said experts did not recommend its use among health workers and senior citizens.

The firm’s late-stage trial in Brazil had shown it had an efficacy rate of 50.4 percent among medical frontline workers — just a few points above the threshold set by the World Health Organization (WHO).

“Therefore, the use of the Sinovac vaccine on health care workers is not recommended,” Domingo said.

Sinovac’s executives have previously defended its vaccine’s relatively low efficacy rate in Brazil, arguing that their participants are medical workers facing a high-risk of contracting Covid-19.

The China-made vaccine is also not recommended for use among the elderly or those aged 65 years old and above since its trial participants in Indonesia and Turkey only included patients aged 18 to 59 years old.

The vaccine was found 65.3 percent effective in the trial in Indonesia, while it had 91.2 percent efficacy rate based on trials done in Turkey.

“When the vaccines arrive in the country, this can be used in groups where safety and efficacy is proven — 18 to 59-year-old clinically-healthy individuals,” Domingo said.

At the Palace, presidential spokesperson Secretary Harry Roque defended CoronaVac even if it was not recommended for health workers and senior citizens, who were identified as the priority sectors for the state’s vaccination program.

“It (the vaccine) is accepted under standards arrived at by the WHO itself,” he said. “I will quote the experts that we have had as guests here, 50 percent efficacy rate is very much accepted. What we want is to avoid deaths, serious illnesses. It’s better than no protection.”

But he admitted that due to the conditions imposed by the FDA on the Sinovac vaccine, “economic frontliners” and soldiers will likely be the first to get the 600,000 doses set to arrive in the Philippines in the coming days, instead of medical workers as initially announced.

The National Immunization Technical Advisory Group is anticipated to revise the initial list of priority sectors for the vaccination program, since the CoronaVac is expected to be the first vaccine that will arrive in the country, he said.

“If we cannot give it to senior citizens and health care workers, we can give it to economic frontliners,” Roque said.

The Palace official defined economic frontliners as workers employed in industries which are allowed to operate under enhanced community quarantine (ECQ), including transport workers, farmers, fishermen, miners, and those in business process outsourcing firms.

Roque and Health Secretary Francisco Duque III said the Chinese Embassy in Manila needs three to five days to prepare the shipment of Sinovac’s vaccine after its EUA was issued.

The issuance of an EUA clears the way for the local use of the vaccine that is expected to boost the country’s immunization campaign, as the Philippine government signed a term sheet with Sinovac for 25 million doses of its vaccine.

Beijing committed to donate 600,000 doses of the coronavirus jab, 100,000 of which will be allocated to military personnel.

Sinovac’s CoronaVac could be distributed to far-flung areas since it only requires normal refrigerated conditions of 2 degrees Celsius (36 Fahrenheit), a temperature within the existing cold chain system in the country.