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Sinovac okayed for emergency use but not for health workers, elderly

The Food and Drug Administration (FDA) gave emergency approval Monday to the Chinese-made Sinovac coronavirus vaccine, with the first doses set to arrive this week, but health workers will not get the jab due to its comparatively low efficacy.

CoronaVac is the third vaccine approved for emergency use in the country, but so far none have been delivered and the Duterte administration is under fire over the delayed rollout.

The Philippines also did not sign an indemnification deal for the Sinovac Biotech jab, Malacañang said on Monday.

An indemnification agreement shields vaccine makers from legal claims stemming from their emergency use.

Beijing has agreed to donate 600,000 doses, which will arrive in the next three to five days, officials said -- despite misgivings over its safety and effectiveness.

“It is decided... that the benefit of using the vaccine outweighs the known and potential risks,” said Eric Domingo, head of the FDA.

Palace spokesman Harry Roque said Congress was set to pass a bill granting indemnity to vaccine makers and establishing a fund to pay claims for damages in the event of adverse effects from the inoculations (see related story on A2 -- Editor).

“The law is applicable to all vaccines,” Roque told reporters in a televised briefing.

The CoronaVac can be given to “clinically healthy” adults aged 18 to 59, but was not recommended for frontline health workers or the elderly, Domingo said.

Roque said workers considered essential to the economy and soldiers were likely to receive the first jabs.

Although trials in Turkey found CoronaVac to be 91.25 percent effective, other, more robust trials in Brazil only demonstrated an efficacy rate of around 50 percent.

Roque defended the push to use the Sinovac vaccine, saying “it’s better than not having protection at all.”

Many world leaders have been among the first in their countries to receive jabs to boost public confidence.

But Duterte preferred to wait for a different Chinese vaccine made by state-owned Sinopharm, Roque said, citing the president’s old age.

The Sinopharm vaccine was secretly given to members of Duterte’s security team last year even though The government is in talks with seven vaccine makers, including Sinovac, in the hope of securing enough doses to inoculate 70 million people -- about 60 percent of the population -- this year.

But the lack of transparency and delays in delivery of the first doses have fueled criticism of the government over its handling of the health crisis.

More than 560,000 cases of coronavirus have been recorded in the country, including over 12,000 deaths. Social distancing rules and travel restrictions have crippled the economy.

Carlito Galvez, a retired general overseeing vaccine procurement, recently admitted the government had not yet signed any supply agreements, only non-binding “term sheets” for potential deals.

More than 100,000 doses of the Pfizer-BioNTech vaccine were supposed to be delivered mid-February through the COVAX global vaccination program.

But Galvez said the delivery had been held up over indemnification agreements that would protect the vaccine makers from legal claims over any side effects.

“I appeal for a little more patience to my fellow Filipinos,” Health Secretary Francisco Duque III said Monday.

Even when vaccines do arrive, it is not clear how many people will want them.

A recent survey by pollster Pulse Asia showed nearly half of Filipinos would opt out.

In approving the Chinese vaccine, Domingo said Sinovac’s efficacy ranged from 65.3 percent to 91.2 percent, but only reached 50.4 percent among health workers with COVID-19 exposure.

“This should be administered by vaccination providers and to prevent COVID-19 in clinically healthy individuals aged 18 to 59 years old,” Domingo said.

“The use of Sinovac COVID-19 vaccine on health care workers is not recommended as it has an efficacy rate of 50.4 percent in this group,” he added.

Defending the use of the Chinese vaccine, Roque said it has met World Health Organization (WHO) standards.

Duque, meanwhile, said a global shortage caused the delay in the delivery of vaccines to the Philippines—even though seven of 10 Southeast Asian nations have already received deliveries of the jabs.

Last week, Galvez also apologized for the delay in the delivery of vaccines, which was initially expected in mid-February with the arrival of 117,000 doses from Pfizer-BioNTech.

On Monday, the House of Representatives passed on second reading the proposed measure aiming to expedite the procurement and administration of COVID-19 vaccines as well as seeking the creation of an indemnity fund.

The fund will ensure compensation for any individual who develops serious side effects after getting a COVID-19 vaccine.

The bill was certified as urgent by President Rodrigo Duterte last week.

In other developments:

* Ambassador to Moscow Carlos Soretta said the Philippines is in the advanced states of talks for the procurement of COVID-19 vaccines from Russia.

* Senator Francis Pangilinan said it was unfortunate that the Simovac vaccine was the first to arrive in the country. “This was not what we were made to expect during the Committee of the Whole hearings wherein we were told that the COVAX vaccines would be arriving by this time,” he said.

* Senator Grace Poe said her proposal for a vaccine passport was only for record keeping and would work like any other vaccination card issued by the Department of Health. She said the benefits that may come from it such as the lifting of restrictions from domestic and international travel and access to certain facilities are purely preparatory for a time when the rest of the world opens up its borders.

Topics: Sinovac vaccine , coronavirus , Food and Drug Administration , health workers
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