Docs face ‘quandary’ as Sino vaccines’ arrival date set

FOR WILLING HEALTH WORKERS The government says the Food and Drug Administration does not recommend CoronaVac for health workers, but does not prohibit its use on those willing to receive it. —AFP

The first batch of donated COVID-19 vaccines from China will arrive in Manila on Sunday, with the government still without a clear plan as to who should get the first shots.

Adding to the confusion is the recommendation of the Food and Drug Administration (FDA) not to give CoronaVac to health workers with high risk of exposure to the coronavirus, based on clinical trial data that showed the vaccine made by the Chinese pharmaceutical company Sinovac Biotech is only 50.4 percent effective on front-line hospital staff.

CoronaVac, however, showed high efficacy rate among ordinary workers and healthy people age 18-59, and 100 percent effective in preventing severe COVID-19.

Some medical experts, like Dr. Rommel Lobo, who sits on the government’s National Adverse Effects Following Immunization Committee, on Thursday said the vaccine program implementers should stick to their original priority list that had front-line health workers at the top.

Break the dilemma

Lobo said 50.4 percent protection for hospital workers was “better than none at all.”

“Because of this limitation imposed by the FDA recommendation, we are now placed in a quandary on who should be prioritized. Should it be the health-care workers or should it be other groups deemed more suited for the [vaccine] by FDA?” the Healthcare Professionals Alliance Against COVID-19 (HPAAC) said.

HPAAC said the only way to “break the dilemma” was to subject CoronaVac to evaluation by the Health Technology Assessment Council (HTAC).

HTAC is an independent body of experts that advises the Department of Health (DOH) on vaccines’ cost-effectiveness, ethics and community impact.

“Though we welcome this donation, we still ask our leaders to await the recommendations of the HTAC—[as] we did with the two previous vaccines that were granted [emergency use authorization] by the FDA before making any hasty moves or decisions,” the group said.

As a process, the FDA issues authorization for vaccines’ safety and efficacy, after which the HTAC reviews the drug, then the National Immunization Technical Advisory Group allocates the vaccine supply.

“If they decide to administer [CoronaVac right] after the [emergency use permit], they are skipping the HTAC evaluation,” HPAAC said.

Donation

The first 600,000 doses of CoronaVac are donated by China and with the two-dose regimen, they are good for 300,000 people. Of the 600,000 doses, 100,000 are allocated for the military. The Philippines, however, is buying 25 million doses more of CoronaVac.

Lobo, also a clinical immunologist at the Philippine Children’s Medical Center (PCMC), said he was “willing to get first in the line” for CoronaVac if the government would give the vaccine to medical workers.

The PCMC is one of the 34 hospitals on the government’s priority list.

Lobo said initial surveys among PCMC employees showed around 50 percent were willing to be inoculated regardless of the vaccine’s brand.

Rollout ‘on hold’

“But [600,000 doses] is actually a small amount, considering there are already 140,000 active [Philippine Medical Association] doctors. We also still have the nurses and orderlies [to vaccinate],” he added.

Presidential spokesperson Harry Roque told an online news briefing on Thursday that the government could start the vaccinations a day after the vaccines’ arrival.

“If it arrives on Sunday, if I am not mistaken, then we can roll out on Monday because many of our countrymen are excited,” Roque said.

But the DOH and the National Task Force Against COVID-19 said in a joint statement Thursday that the rollout was “on hold.”

They said the allocation and rollout of the vaccine were “still being evaluated” and needed “official recommendation” of the immunization advisory group and the Inter-Agency Task Force for the Management of Emerging Infectious Diseases, the temporary government body overseeing the Duterte administration’s coronavirus response.

Roque shrugged off data showing the Philippines was the last country in Southeast Asia to receive COVID-19 vaccines, saying the difference was just a number of days.

“This has no major significance,” Roque said.

The Philippines has the second highest number of coronavirus infections and deaths in the region. On Thursday, the DOH reported 2,269 additional infections, pushing the overall number of confirmed COVID-19 cases in the country to 568,680.

The DOH said 72 more patients had died, raising the death toll to 12,201. It also reported that 738 other patients had recovered, bringing the total number of COVID-19 survivors to 524,042.

Those deaths and recoveries left the country with 32,437 active cases, of which 88.5 percent were mild, 6.1 percent asymptomatic, 0.78 percent moderate, 2.3 percent severe and 2.4 percent critical.

Higher prices

Carlito Galvez Jr., who handles vaccine procurement for the government, said the Philippines was trying to expedite the delivery of vaccines by offering higher prices.

“We are negotiating, even if it would be slightly more expensive, as long as there would be early delivery in the second and third quarter,” Galvez said in a meeting with President Duterte on Wednesday evening.

“That is the technique we are doing, we are offsetting their prices. The prices would be increased for earlier delivery,” he said.

Aside from CoronaVac, 10,000 doses of New Crown, the COVID-19 vaccine developed by China National Pharmaceutical Group (Sinopharm) will arrive soon, under a “compassionate use” authorization from the FDA for President Duterte’s security detail. Galvez said 3.5 million doses from Pfizer and AstraZeneca from global vaccine pool COVAX, and 1 million doses bought by the DOH would arrive in the first quarter.

Another 24 million doses are expected in the second quarter, while the bulk of the Philippines’ orders will arrive in the third and fourth quarter, he said.

New Crown was actually administered to troops from the Presidential Security Group in September and October but without FDA authorization. The FDA is investigating the illegal use of the vaccine, reportedly donated but by whom the presidential guard’s commander, Army Brig. Gen. Jesus Durante III, refused to identify.

Roque said CoronaVac could still be given to willing health workers, despite the FDA recommendation.

He said the FDA recommendation was not to give CoronaVac to health workers, but the agency did not prohibit using the vaccine.

Any approved vaccine

Gerardo Legaspi, director of the University of the Philippines-Philippine General Hospital in Manila, said he would accept any COVID-19 vaccine authorized by the FDA.

“I think the important thing to remember here is whatever vaccine comes, we should welcome it because it will definitely make a difference in helping control the spread of this infection, and I think the first area where we should control it would be the hospitals,” Legaspi said.

Maj. Gen. Edgard Arevalo, spokesperson for the military, told a news briefing on Thursday that inoculation was not an option for the troops, but a duty. “We must take the vaccine without delay once rollout starts,” he said. —WITH REPORTS FROM PATRICIA DENISE M. CHIU, JEANNETTE I. ANDRADE AND REUTERS

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