Duterte asked to quicken vaccine approvals

By Gillian M. Cortez and Vann Marlo M. Villegas, Reporters

THE HEALTH department asked President Rodrigo R. Duterte on Tuesday night to issue an order that will fast-track the approval process for coronavirus vaccines.

“We are respectfully requesting that you consider the issuance of an executive order for the Food and Drug Administration (FDA) to grant an emergency use authorization for the various vaccines that will enter the country,” he told the President at a televised meeting.

The executive order would cut the processing time to 21 days from six months, Mr. Duque said.

The recommendation came as countries around the globe race to develop a vaccine against the virus that has sickened 56 million and killed 1.3 million people worldwide. The Philippines is preparing orders for the vaccines that may come next quarter.

Mr. Duque said the emergency use authorization could only be used if there is a medical health emergency or a life-threatening disease, and there is proof that a drug could prevent, diagnose, or treat it.

At the same meeting, vaccine czar Carlito G. Galvez, Jr. said the private sector would help fund the vaccines through a public-private tripartite agreement.

Under the deal, companies will buy the vaccines directly from the drug maker and will then donate these to the government, which will be the one to choose the beneficiaries, he said.

The Lucio Tan Group, San Miguel Corp. and Go Negosyo have pledged to donate vaccine doses, Mr. Galvez said. Business tycoon Enrique K. Razon also committed to donate 300,000 doses, he added.

The government is planning to buy as many as 50 million doses of coronavirus vaccines once these become available.

The Department of Health (DoH) reported 1,383 coronavirus infections on Wednesday, bringing the total to 412,097.

The death toll rose to 7,957 after 95 more patients died, while recoveries increased by 143 to 374,666, it said in a bulletin.

There were 29,474 active cases, 83.8% of which were mild, 8.3% did not show symptoms, 4.9% were critical, 2.7% were severe and 0.22% were moderate.

Cavite reported the highest number of cases at 81, followed by Laguna at 74, Batangas at 71, Quezon City at 69 and Rizal at 67.

The agency said four duplicates had been removed from the tally, while 18 cases previously tagged as recovered were reclassified as deaths. Seventeen laboratories failed to submit their data on Nov 17, the agency said.

The coronavirus has sickened about 55.9 million and killed 1.3 million people worldwide, according to the Worldometers website, citing various sources including data from the World Health Organization.

About 39 million people have recovered, it said.

CLINICAL TRIALS
Meanwhile, Health Undersecretary Maria Rosario S. Vergeire said the lack of clinical trials in the country would not affect government orders of COVID-19 vaccines.

“If the manufacturer will not conduct a clinical trial here in the country, this won’t affect our decision to order the vaccine,” she told an online news briefing in mixed English and Filipino.

Moderna, Inc. had informed Science and Technology officials that it does not plan to hold clinical trials here for a coronavirus vaccine it was developing, Ms. Vergeire said. The company claims the drug is 94.5% effective.

Pfizer, claims its vaccine is 90% effective, also does not plan to conduct clinical trials in the Philippines, she said.

Ms. Vergeire said a drug only needs to go through the regulatory process.

China’s Sinovac Biotech Ltd.’s application for clinical trials had been approved by an expert panel from the Science and Technology department. A separate ethics board must also approve the application before Sinovac can apply for approval from the local Food and Drug Administration (FDA).

President Rodrigo R. Duterte last month said the government had funds to buy coronavirus vaccines, but it needs more so the entire population of more than 100 million could be inoculated.

Mr. Duterte said he had spoken with outgoing Russian Ambassador Igor A. Khovaev and was told that Russia intends to set up a pharmaceutical company in the Philippines that will make the vaccines available here.

Meanwhile, vaccine maker Serum Institute of India Pvt. Ltd. has authorized Faberco Life Sciences, Inc. to represent the Philippines for the supply of coronavirus vaccines it is developing with US biotechnology company Novavax, Inc.

Fabreco has partnered with the Indian drug maker for key vaccine programs such as inactivated polio, rotavirus, pneumococcal conjugate and COVID-19 vaccines.

“The President himself has expressed doubts if the Philippines will get vaccines being developed in the West,” Luningning Villa, a medical director at Faberco, said in a statement. “If and when the vaccine becomes available, SII and Faberco hope to bring a pleasant surprise.”

Fabreco is a distributor of specialized healthcare products.

Serum Institution in August signed a license agreement with Novavax for the development and commercialization of a coronavirus vaccine.

Serum also joined the COVID-19 Vaccines Global Access co-led by Gavi, the Vaccine Alliance, Coalition for Epidemic Preparedness Innovations, and the World Health Organization, which aims to ensure availability of COVID-19 vaccines to all countries.

Novavax is set to start phase 3 clinical trials in the US this month and was given a “fast-track status” by the US Food and Drug Administration. A late-stage study of the vaccine was conducted in the United Kingdom, it said.

Ms. Villa told BusinessWorld in a phone call the vaccine was targeted to be available by June 2021. Its availability will depend on the result of the clinical trials.

Its availability in the Philippines will depend on the local registration process. Ms. Villa also said the vaccine is expected to be “logistically manageable” in terms of cold chain requirements because it does not require deep freezing during storage and transport.

At least 300 million doses have been committed to other countries, she said, adding that some may be allocated to the Philippines if there is an advanced negotiation.

The company had informed government agencies about the potential vaccine, she said.