DOH: Vaccine trials down to ‘3 to 4’ choices

Health Undersecretary Maria Rosario Vergeire on Friday said the World Health Organization (WHO) had trimmed down to “three to four” the number of candidate COVID-19 vaccines being considered for inclusion in the Solidarity Trial program scheduled to begin in the country next month.

The Solidarity Trial is a global effort led by the WHO to find a vaccine for the severe respiratory disease that has afflicted more than 300,000 people in the country.

Vergeire said that while the WHO had yet to provide the Department of Health (DOH) with the list of vaccines to be used in the trial, DOH officials were told that the number of vaccines under consideration was down to three to four.

The WHO earlier committed to the DOH that it would release the list of vaccines included in the trials by the third or fourth week of October.

Dr. Socorro Escalante, WHO Western Pacific COVID-19 incident manager, also said earlier there were 17 vaccines being evaluated to be included in the global clinical trial.

Final phase

Among the considerations for a vaccine’s inclusion are its safety profile and potential for efficacy, availability and practicality of implementation. “[It means] the regimens are manageable considering the resource settings of countries,” Escalante said.

At present, phase 3 clinical trials have begun or are about to begin for 11 candidate vaccines. It is the final phase where thousands of subjects are tested; the first phase involves only dozens of volunteers, while the second expands to trial to cover hundreds.

Trials for Johnson & Johnson’s and AstraZeneca’s candidate vaccines have been put on hold after each had a tested participant who later fell ill.

The DOH has yet to disclose the 12 hospitals where the trials will be held, but said these are located in Metro Manila, Calabarzon (Cavite, Laguna, Batangas, Rizal and Quezon), Cebu and Davao.

“For the clinical trial, only a few vaccines [will arrive] so it’s very manageable but we are still preparing,” Vergeire said.

Avigan trial

Meanwhile, the clinical trial in the country for the Japanese antiflu drug Avigan has been put off several times that the four hospitals designated as trial sites are now having difficulty recruiting patients.

“There has been a bit of a challenge in recruiting patients because of the decreasing number of patients, and we also have other drug trials—remdesivir, interferon, acalabrutinib—and we can’t give Avigan on top of that,” Vergeire said.

The Avigan trial was initially scheduled to start in mid-July but was delayed as legal arrangements were still being finalized.

Japan approval

The Japanese government delivered in early August tablets enough to be used on 100 patients.

In late September, Avigan’s manufacturer Fujifilm Toyama Chemical Co. Ltd. announced it would seek Japan’s regulatory approval following the results of its clinical trial that showed the drug helped shorten the recovery time of COVID-19 patients.

It was only in the first week of October that the DOH announced that a clinical trial agreement with the University of the Philippines Manila had finally been signed.

Four sites were identified for the trial—the Philippine General Hospital, Sta. Ana Hospital, Dr. Jose N. Rodriguez Memorial Hospital and Quirino Memorial Medical Center.

Virus case update

Vergeire said that “what we need now is to restrategize. There were [suggestions] to expand the number of hospitals, but if we do that we would need to revise our clinical trial protocol, which may cause yet another delay.”

“We are not going to that option yet. We will ask help from the medical directors [of the trial sites] to expedite the start of this trial,” she said.

On Friday, the DOH recorded an additional 1,923 cases, pushing the national tally to 365,799.

Of the new cases, 1,745 fell ill between Oct. 10 and Oct. 23, while 69 got sick between Oct. 1 and Oct. 9. Davao City had the most number of infections, 99, followed by Cavite (94), Manila (94), Quezon City (92) and Negros Occidental (89).

The total number of COVID-19 survivors climbed to 312,691 with the recovery of 424 more patients. The death toll, however, rose to 6,915 as 132 patients succumbed to the severe respiratory disease.

Of the newly reported deaths, 76 died in October, 30 in September, nine in August, 14 in July, one in June and two in April.

Forty-seven of the fatalities were from Metro Manila, 33 from Central Luzon, 23 from Calabarzon, 10 from Western Visayas, eight from Central Visayas, three from Bicol, two from Caraga, and one each from Ilocos, Davao, Soccsksargen, the Bangsamoro Autonomous Region in Muslim Mindanao and the Cordillera Administrative Region.

A repatriate was also listed to have died from COVID-19.

The recoveries and deaths left the country with 46,193 active cases, of which 83.6 percent are mild, 11.3 percent asymptomatic, 1.8 percent severe and 3.2 percent critical.

As of Friday noon, a total 4,249,160 patients have been tested for COVID-19 by the 150 accredited laboratories.