AstraZeneca applies for emergency use

    The Food and Drug Authority in Alabang, Muntinlupa. (Photo courtesy of Adaman Phils)

    By Gerard Naval and Jocelyn Montemayor

    THE British-Swedish pharmaceutical company AstraZeneca yesterday applied for emergency use authorization (UAE) in the Philippines as the Food and Drug Administration said it could come out with a decision next week on the application of another COVID-19 vaccine maker, the US firm Pfizer Inc.

    AstraZeneca’s COVID-19 vaccine (Photo by REUTERS)

    FDA Director General Eric Domingo said a decision on Pfizer’s application may be out by January 14.

    “Yesterday, we had some clarificatory questions for Pfizer and they were given 48 hours to reply and to give us the information requested by our panel,” he said in a briefing. “After that, it will be submitted to me by January 10. A few days after that, we can already have a decision on their EUA application.”

    Pfizer filed its application with the FDA on December 23.

    Domingo said the evaluation of Pfizer’s application was greatly aided by EUAs the company has secured from the United Kingdom, United States, Canada, Switzerland, and Singapore, among others, as well as the “emergency listing” of the World Health Organization.

    “What is good about Pfizer’s application is we know it already went through strict regulatory evaluation in those countries,” said Domingo.

    On AstraZeneca, Domingo said it could take the FDA three to four weeks to complete an assessment, “depending on the completeness of their submission.” AstraZeneca has obtained UAEs from the UK and India.

    It can be recalled that AstraZeneca signed a tripartite agreement with the Philippine government and the country’s private sector last November for the supply of 2.6 million doses of COVID-19 vaccine.

    Domingo said the process to grant UAEs is being hastened due to the public health emergency but without sacrificing stringent screening procedures.

    “The process is going fast but still goes through each and every step to make sure of the quality, safety, and efficacy of the vaccines,” he said.

    It was back in December when President Duterte authorized the FDA to issue an EUA for vaccine candidates.

    As for local clinical trials for candidate COVID-19 vaccines, Domingo said the country is looking at Janssen starting by next week. Janssen’s clinical trial bid was approved by the FDA on December 29.

    Janssen Pharmaceutica is a company based in Belgium and owned by Johnson & Johnson.

    “They will start this month, probably by next week, for the very promising vaccine they are developing,” said Domingo.

    The Department of Health previously said five sites are being eyed for the Janssen clinical trials.

    The Chinese firms Sinovac Biotech and Clover Biopharmaceuticals have also applied to hold clinical trials in the Philippines. Their applications are still being evaluated by the FDA.

    The World Health Organization (WHO) said the Philippines is on track as far as a COVID-19 vaccine rollout is concerned.

    “The Philippines is on track in terms of its preparation for the vaccines introduction and for the vaccines rollout, including the distribution of the vaccines across the country,” said Socorro Escalante, acting WHO Representative in the Philippines.

    But she warned government against being “derailed” in the implementation of the vaccination program as some sectors are expected to demand to be vaccine recipients.

    “We would be expecting a lot of demand from the public. And because of the pressure of the public, it is possible that the government can be derailed in its very systematic vaccine plan,” she said.

    Under the current priority list, among the first to receive COVID-19 vaccines are health workers, senior citizens, indigent population, uniformed personnel, and school workers.

    Also listed are government workers; essential workers, such as in the food, transportation, and tourism sectors; groups in higher risk areas; OFWs; remaining workforce; and students.

    Vaccine czar, Carlito Galvez Jr. said the government is in advanced stages of negotiations with seven vaccine manufacturers and “based on our current negotiations, we will be able to purchase at least 148 million doses.”

    Galvez, also chief implementer of the National Task Force Against COVID-19, said the delivery of the vaccines would depend on the availability of supply.

    He said 80 percent of the global supply has been reserved by rich countries.

    Galvez named the vaccine makers AstraZeneca, Pfizer, Johnson & Johnson, Sinovac, Russia’s Gamaleya and American Novavax Inc.

    “We hope to close the deal with these companies this month. At ito po ay nakikita po natin na kapag nagkaroon po tayo ng very effective na negotiation ay mayroon po tayong mahigit na 148 million na magkakaroon po ng doses (We hope to close the deal with these companies this month. And we foresee that if we have very effective negotiation, we can have more than 148 million doses,” he added.

    Galvez also said the vaccines from Pfizer are expected to be delivered to the country in the third to fourth quarter of the year, instead of the second quarter or third quarter of 2021, because of high demand.

    Those from AstraZeneca are expected in the third quarter.

    The government negotiation with AstraZeneca is separate from the tripartite agreement of the national government with the private sector and the pharmaceutical firm in late 2020 for 2.6 million doses due for delivery in the second to third quarter of this year. A second batch for 3.7 million to 3.8 million is in the final stages of negotiations.

    Galvez said President Duterte has allowed local government units (LGUs) to procure vaccines for their own constituents with the help of the national government.

    He said agreements for vaccines are currently forged under a government-to -government scheme or national government to pharmaceutical scheme.

    He said the President is thankful for the LGU’s efforts and they may buy the vaccine using the current tripartite scheme used by the private sector.

    Testing czar Vince Dizon, deputy chief implementer of the National Task Force Against COVID-19, said this means LGUs may now enter into tripartite agreement with the national government and pharmaceutical firms to buy the vaccines.

    Dizon said the arrangement is due to the “very limited supply of vaccines.”

    He said LGUs also would benefit from the “special rates,” or lower price of vaccines, that is given to the national government.

    Quezon City Mayor Joy Belmonte on Tuesday entered into a agreement for the procurement of an initial 750,000 doses from AstraZeneca for health workers, senior citizens, and persons with disabilities.

    Belmonte signed the agreement with National Task Force Against COVID-19 and Astra Zeneca Pharmaceuticals Philippines after the QC Council authorized her to pre-order vaccines.

    Marikina City Rep. Stella Quimbo filed a resolution calling for an inquiry into the status of the government’s vaccine procurement program, citing public concern about the big amount of public funds involved and invoking the oversight powers of Congress.

    Quimbo said P72.5 billion has been appropriated under the 2021 national budget for the purchase of vaccines for an estimated 60 million Filipinos. The sum consists of P70 billion in unprogrammed appropriations and P2.5 billion in the regular budget of the Department of Health.

    She also cited the government’s plan to secure additional $300 to P325 million loans from the World Bank and the Asian Development Bank to fund vaccine acquisition for the rest of the population.

    Quimbo noted that on top of these, wealthier local government units have also announced plans to acquire vaccines for their own constituencies not counting similar moves by the private sector. – With Victor Reyes and Peter Tabingo