DOH: Vaccine trials up to ‘3 to 4’ options



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The Undersecretary of Health, María Rosario Vergeire, said on Friday that the World Health Organization (WHO) had reduced to “three or four” the number of candidate COVID-19 vaccines that are being considered for inclusion in the Test program. Solidarity that will begin in the country next month.

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

Vergeire said that while WHO had not yet provided the Department of Health (DOH) with the list of vaccines that would be used in the trial, DOH officials were informed that the number of vaccines under consideration had been reduced to three or four.

WHO previously committed to DOH to publish the list of vaccines included in the trials by the third or fourth week of October.

Dr Socorro Escalante, WHO’s Western Pacific COVID-19 Incident Manager, also previously said that 17 vaccines were being evaluated for inclusion in the global clinical trial.

Final phase

Considerations for the inclusion of a vaccine include its safety profile and its potential for efficacy, availability, and practicality of implementation. “[It means] the regimes are manageable considering the countries’ resource configuration, ”Escalante said.

Currently, 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 evaluated; the first phase involves only dozens of volunteers, while the second expands on trial to cover hundreds.

Trials of the Johnson & Johnson and AstraZeneca candidate vaccines were suspended after each had a participant who later became ill.

The DOH has not yet disclosed the 12 hospitals where the trials will take place, but said they 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’re still getting ready, ”said Vergeire.

Avigan’s Trial

Meanwhile, the country’s clinical trial of the Japanese flu drug Avigan has been postponed multiple times because the four hospitals designated as trial sites are now struggling to recruit patients.

“There has been a little challenge in recruiting patients due to the decrease in patient numbers, and we also have other drug trials (remdesivir, interferon, acalabrutinib) and we can’t add Avigan on top of that,” Vergeire said.

Avigan’s trial was initially scheduled to begin in mid-July, but was delayed because legal arrangements were still being finalized.

Japan approval

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

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

It was not until the first week of October that DOH announced that a clinical trial agreement had finally been signed with the University of the Philippines in Manila.

Four trial sites were identified: the Philippine General Hospital, Sta. Ana Hospital, Dr. José N. Rodríguez Memorial Hospital, and Quirino Memorial Medical Center.

Virus case update

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

“We are not going to that option yet. We will ask medical directors for help [of the trial sites] to speed up the start of this trial, “he said.

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

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

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

Of the recently 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 deaths 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 from Ilocos, Davao, Soccsksargen, Bangsamoro Autonomous Region of the Muslim Mindanao and Cordillera Administrative Region.

It was also indicated that a returnee died from COVID-19.

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

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