FDA raises hopes for vaccines – Manila Standard

A COVID-19 vaccine may be available in the Philippines as of March 2021 following recent developments abroad, Food and Drug Administration (FDA) Director General Eric Domingo said Thursday. Domingo made the screening at a Palace briefing one day after the UK approved the use of Pfizer-BioNTech’s COVID-19 vaccine. Domingo said there is information that the US FDA is also preparing to issue an emergency use authorization for COVID-19 vaccines developed by Pfizer and Moderna within two weeks. He said if drug companies applied here in January, they could receive an emergency use authorization, a move that would improve the chances of having a vaccine ready for distribution in March. He said this could happen even in January, but this would depend on how soon companies could increase production and when they could allocate doses for the Philippines. Domingo said that if companies applied for an EUA, the FDA could make a decision within 21 to 28 days. He added that the Pfizer-BioNTech vaccine has a good chance of securing an EUA in the Philippines if you request one. He said the FDA’s UK counterpart, which awarded the Pfizer-BioNTech vaccine an EUA, was a strict regulatory authority that had thoroughly scrutinized all the data. Still, he said his agency would like information on the stability of the vaccine in a tropical environment. He said they would also want to know if there were enough Asians or Filipinos among their test subjects to evaluate the drug’s safety and efficacy in different ethnic groups. In a separate interview, Dr. Jaime Montoya of the Philippine Council for Health Research and Development (PCHRD) said that you can expect FDA approval of a drug or vaccine in 40 days or less now that you are allowed to issue a USA. He added that the process will also be faster for drugs or vaccines that have been administered in the US in other countries. On Wednesday, Malacañang announced that President Rodrigo Duterte, through Executive Order 121, allowed the FDA to issue an EUA for COVID-19 drugs and vaccines. The Philippines hopes to purchase vaccines developed by the United States, China, Russia and the United Kingdom. Domingo said the government would not force people to get vaccinated against COVID-19, and said people would only be inoculated after full disclosure of the potential risks and benefits of the vaccine. “They can’t make you do it and this is not mandatory,” Domingo said in Filipino. But to allay fears about the vaccines, which are seen to help turn the tide of the global pandemic, Domingo assured the public that they would not compromise his safety. “We would like to assure the public that we take it very seriously. We will ensure that the benefits outweigh the risk more than anything else before granting emergency use authorization for any vaccine, ”he said. To bolster public confidence, the Department of Health (DOH) is scheduled to conduct a vaccine education campaign to allow the public to make an informed decision, Domingo said. Meanwhile, the Department of Health (DOH) said it will identify priority areas where COVID-19 vaccines developed by British firm AstraZeneca and the University of Oxford will be administered, the agency said. “Since this would be a tripartite agreement and the EUA (emergency use authorization) will be issued by the [Philippine] government, the allocation framework that companies would follow would be that prescribed by the Department of Health, ”said DOH. Previously, the government and private companies signed an agreement with AstraZeneca for the acquisition of 2.6 million doses of COVID-19 vaccines from the drug manufacturer. Under the agreement, 50 percent of the vaccines will be distributed to areas identified by DOH. The remaining half will go to geographic areas or sectors identified by the private companies that purchased the vaccine. The Palace said on Thursday that the president will attend a virtual session of the 31st special session of the United Nations General Assembly (UNGA) on the COVID-19 pandemic from December 3-4. Presidential spokesman Harry Roque said the president is expected to deliver the Philippine statement on December 3, New York time. “The president will further expand his call for global solidarity to address the challenges posed by the COVID-19 pandemic,” Malacañang said in a statement. The president is particularly concerned about “universal access to anti-COVID-19 technologies and products and the need for global efforts to ensure the availability of safe and effective vaccines for the people of developing nations,” Roque said. Earlier, the president said that access to COVID-19 vaccines “must not be denied or withheld.” “It should be available to everyone, rich and poor countries alike, as a matter of policy,” he said during the general debate at the 75th session of the UNGA last September.