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By Gillian M. Cortez Y Vann Marlo M. Villegas, Reporters
The HEALTH department asked President Rodrigo R. Duterte on Tuesday night to issue an order that will speed up the approval process for coronavirus vaccines.
“We are respectfully requesting that you consider issuing 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,” the president told a televised meeting.
The executive order would reduce the processing time from six months to 21 days, Duque said.
The recommendation came as countries around the world rushed 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 arrive next quarter.
Duque said the emergency use authorization can only be used if there is a medical emergency or life-threatening illness, and there is evidence 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 finance vaccines through a public-private tripartite agreement.
Under the agreement, the companies will buy the vaccines directly from the drug maker and then donate them to the government, which will choose the beneficiaries, he said.
The Lucio Tan Group, San Miguel Corp. and Go Negosyo have pledged to donate doses of vaccines, Galvez said. Business magnate Enrique K. Razón also pledged to donate 300,000 doses, he added.
The government plans to buy up to 50 million doses of coronavirus vaccines once they are 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 rose by 143 to 374,666, it said in a bulletin.
There were 29,474 active cases, of which 83.8% were mild, 8.3% had no symptoms, 4.9% were critical, 2.7% were severe, and 0.22% were moderate.
Cavite reported the highest number of cases with 81, followed by Laguna with 74, Batangas with 71, Quezon City with 69 and Rizal with 67.
The agency said four duplicates had been removed from the count, while 18 cases previously labeled as recovered were reclassified as deaths. Seventeen labs did not submit their data on Nov.17, the agency said.
The coronavirus has sickened an estimated 55.9 million and killed 1.3 million people worldwide, according to the Worldometers website, which cites multiple sources, including data from the World Health Organization.
About 39 million people have recovered, he said.
CLINICAL TRIALS
Meanwhile, Undersecretary of Health María Rosario S. Vergeire said that the lack of clinical trials in the country would not affect government orders for COVID-19 vaccines.
“If the manufacturer does not conduct a clinical trial here in the country, this will not affect our decision to order the vaccine,” he told an online news conference in a mix of English and Filipino.
Moderna, Inc. had informed science and technology officials that it does not plan to conduct clinical trials here for a coronavirus vaccine it was developing, Vergeire said. The company claims that the drug is 94.5% effective.
Pfizer, claims its vaccine is 90% effective, also does not plan to conduct clinical trials in the Philippines, he said.
Ms Vergeire said that a drug only needs to go through the regulatory process.
China Sinovac Biotech Ltd.’s clinical trial application had been approved by a panel of experts from the Department of Science and Technology. An independent ethics board must also approve the application before Sinovac can seek approval from the local Food and Drug Administration (FDA).
President Rodrigo R. Duterte said last month that the government had funds to buy coronavirus vaccines, but needs more so that the entire population of more than 100 million can be inoculated.
Mr. Duterte said that he had spoken with outgoing Russian ambassador Igor A. Khovaev and was told that Russia intends to establish a pharmaceutical company in the Philippines that will make vaccines available here.
Meanwhile, the vaccine manufacturer Serum Institute of India Pvt. Ltd. has authorized Faberco Life Sciences, Inc. to represent the Philippines for the supply of coronavirus vaccines that it is developing with the American 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 that the Philippines will obtain the vaccines that are being developed in the West,” Luningning Villa, Faberco’s chief medical officer, said in a statement. “When the vaccine is available, SII and Faberco hope to bring a pleasant surprise.”
Fabreco is a distributor of specialized sanitary products.
Serum Institution in August signed a licensing agreement with Novavax for the development and commercialization of a coronavirus vaccine.
Serum also joined the COVID-19 Vaccines Global Access co-chaired by Gavi, Vaccine Alliance, Coalition for Epidemic Preparedness Innovations, and the World Health Organization. whose objective is to guarantee the availability of COVID-19 vaccines in all countries.
Novavax is scheduled to begin phase 3 clinical trials in the US this month and has been granted “fast track status” by the US Food and Drug Administration. A late-stage study of the vaccine was conducted in the UK, he said.
Ms. Villa said Business world In a phone call, the vaccine was intended to be available in June 2021. Its availability will depend on the outcome of 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 freezing during storage and transportation.
At least 300 million doses have been committed to other countries, he said, adding that some could be assigned to the Philippines if there is advanced negotiation.
The company had informed government agencies about the possible vaccine, he said.
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