PH to roll out AstraZeneca jab amid efficacy issue

The scheduled rollout of AstraZeneca COVID-19 vaccine in the Philippines in the first quarter of 2021 will proceed unhampered, pending findings that it will not be effective against the dominant original variant of the coronavirus in the Philippines, the Food and Drug Administration said.

FDA Director General Eric Domingo made the statement Tuesday in light of South Africa deferring its AstraZeneca vaccine rollout since it had been found to have a low efficacy rate against the coronavirus variant found there.

 “We are still waiting for their data on the new variants. It still has no effect on us because the South African variant has not been seen in the Philippines.

Even the UK variant, only a few,” Domingo said during the Laging Handa briefing.

But the World Health Organization insisted that the AstraZeneca vaccine was still a vital tool in the global fight against the coronavirus pandemic, after South Africa delayed the start of its inoculation program over concerns about the drug’s efficacy against a virus variant.

As concerns rose over the AstraZeneca shot, the United States said it had lost its first sitting member of Congress to the virus, 67-year-old Texas Republic Ron Wright, who had also been battling cancer.

President Joe Biden called Wright a “fighter who battled bravely against both cancer and COVID-19.” His death came after a 41-year-old Republican House member-elect lost his life to the disease in December, just days before he was to be sworn in.

Meanwhile, Presidential spokesman Harry Roque said the brand of COVID-19 vaccine that would be given to President Rodrigo Duterte would depend on his doctor’s advice.

Roque made the response when asked if President Duterte, who turns 76 next month, would be among the first to be inoculated with the Pfizer-BioNTech vaccine as part of the prioritized elderly sector.

The first batch of the Pfizer-BioNTech vaccine under the COVAX facility was expected to arrive in the country within the month, ahead of the President’s preferred Chinese and Russian vaccines.

“This issue will have to be discussed by the President with his physician,” Roque said during a briefing.

“He is under the advice of his physician,” Roque added.

In a related development, the first batch of coronavirus vaccines from Pfizer-BioNTech will be distributed to several hospitals across Metro Manila as well as certain healthcare facilities in Cebu and Davao, Health Undersecretary Maria Rosario Vergeire said Tuesday.

Vergeire, in an interview on CNN-Philippines, said Pfizer-BioNTech vaccines would go to several other hospitals apart from the country’s main COVID-19 referral centers.

The Department of Health earlier said all staff of the Philippine General Hospital, Lung Center of the Philippines, Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium, and East Avenue Medical Center would be inoculated first.

“It’s not just those four hospitals that we’re going to provide these vaccines with. We are going to provide other DOH-designated hospitals for COVID and that would include specific hospitals in Cebu and also in Davao,” Vergeire said.

Doses from the first batch will also be given to DOH hospitals serving as COVID-19 referral centers, big hospitals of local government units, and five private hospitals, all of which are in Metro Manila, she added.

“We’re talking about 58,500 doses because we need to reserve the second dose of all of these healthcare workers that will be initially given by Pfizer,” Vergeire explained.

 Authorities are still awaiting confirmation on the delivery date of the first batch of vaccines from the World Health Organization-led COVAX Facility.

The Philippines expects to receive 117,000 doses from Pfizer-BioNTech  this month.

Domingo said the same emergency use authorization issued to AstraZeneca vaccine would be used which the FDA found had a 70 percent efficacy rate—a rate that increases after the second dose had been administered four to 12 weeks after.

In addition, Domingo said the World Health Organization had yet to see any different indication of diminished efficacy rate for AstraZeneca.

“The WHO has told us that they have not seen any change in the indication of AstraZeneca, but they will keep everybody updated if its efficacy rate [AstraZeneca] decreases with the circulating variant,” Domingo said.

Domingo, however, clarified that the EUA issued to AstraZeneca and the efficacy rate of COVID-19 vaccines were not set in stone.

Domingo said, as of this time, there was no indication of lower efficacy rate.

A number of local government units have signed agreements with AstraZeneca for the supply of COVID-19 vaccines to their constituents.

In South Africa, alarm was raised when a trial at Johannesburg’s University of Witwatersrand concluded the AstraZeneca vaccine provided only “minimal” protection against mild to moderate Covid-19 caused by the variant first detected in South Africa.

That was bad news for many poorer nations counting on the logistical advantages offered by the AstraZeneca shot.

But Richard Hatchett, head of the Coalition for Epidemic Preparedness Innovations (CEPI), said it was “vastly too early to be dismissing this vaccine.”

“It is absolutely crucial to use the tools that we have as effectively as we possibly can,” he said, speaking at the WHO’s regular bi-weekly press briefing on the pandemic.

The AstraZeneca vaccine is currently a vital part of Covax, the system set up to procure Covid-19 vaccines and ensure their equitable distribution around the world.

It accounts for almost all of the 337.2 million vaccine doses Covax is preparing to begin shipping to some 145 countries during the first half of the year, once it receives WHO authorization, expected next week.

South Africa, the continent’s hardest-hit nation, had been due to start its campaign in the coming days with a million AstraZeneca doses.

However, the government decided to hold off because of the results from the trial.

“It’s a temporary issue that we have to hold on AstraZeneca until we figure out these issues,” Health Minister Zweli Mkhize said Sunday.

South Africa has 1.5 million AstraZeneca vaccine doses, which will expire in April.

AstraZeneca also stood by its product.

“We do believe our vaccine will still protect against severe disease,” it told AFP.

A company spokesperson said researchers were already working to update the vaccine to deal with the South African variant spreading rapidly around the world.

Worldwide, the coronavirus pandemic has claimed more than 2.3 million lives out of 106 million known infections.

Meanwhile, the Food and Drug Administration said Tuesday it expected two other COVID-19 vaccine frontrunners to soon apply for emergency use authorization in the country.

“For Moderna, they might apply in the next few weeks. They have already asked us questions and we gave them information on the process,” FDA Director General Domingo said during a Laging Handa briefing.

Currently, only American company Pfizer and United Kingdom-based AstraZeneca have EUA’s in the Philippines.

This allows their vaccines to be used in the country’s national immunization program. An EUA does not allow the commercial selling of the vaccines.

The country expects the arrival this month of vaccine supplies from Pfizer and AstraZeneca under the COVAX facility, after which, inoculation of the target population may immediately begin,  Presidential spokesman Harry Roque said.

Both Moderna and Novavax are American companies as well, although the latter has a manufacturing agreement with the Serum Institute of India.

Other vaccine frontrunners (or those that already reached Phase III clinical trials) that have applied for EUA in the Philippines are China’s Sinovac and Russia’s Gamaleya Institute.

“For Sinovac and Gamaleya, we’re still waiting for some answers to queries by experts and some documents on the production and product quality,” Domingo said.

While Sinovac is reported to have already been approved for public use in China, it has not given the Philippines’ FDA a copy of such authorization for general use, Domingo said.

“The evaluation of Sinovac’s application is ongoing and hopefully it is completed soon,” he said.

Sinovac has pledged 25 million doses of its COVID-19 vaccine to the Philippines.

 Domingo said Bharat Biotech from India, which also applied for EUA in the Philippines, still has not submitted its Phase III trial results, restraining the FDA from starting its evaluation process.

The Philippines’ COVID-19 vaccine czar, Sec. Carlito Galvez, Jr., said Sunday that the country expected to receive a total of around 152 million doses of vaccines against the coronavirus.

He said the country has so far signed term sheets with 5 drugmakers amounting to some 108 million doses of COVID-19 vaccine, on top of the 44 million that the World Health Organization said it would give under the COVAX Facility.

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