(UPDATED) The Food and Drug Administration (FDA) on Thursday, January 14, 2021, announced that it has issued an Emergency Use Authorization (EUA) for the Covid-19 candidate vaccine developed by Pfizer and BioNTech.
FDA Director General Enrique Domingo, in a virtual forum, said the EUA for the Pfizer-BioNTech vaccine (BNT162b2) would remain in effect in the Philippines for the duration of the public health emergency.
In this case, Domingo said the EUA is good until the end of the year. This is the first EUA for a vaccine against coronavirus disease 2019 (Covid-19) in the Philippines.
“After a thorough review of the currently available data by medical and regulatory experts, the FDA today is granting Emergency Use Authorization to Pfizer-BioNTech Covid-19 vaccine,” Domingo announced.
“The interim data from the ongoing phase 3 trial shows that the vaccine has an efficacy of 95 percent in the study population and at least 92 percent among all racial groups,” he added.
Domingo said all conditions for the issuance of an EUA were met. Their assessment also showed that the benefits of using the vaccine outweigh the known and potential risks of the product.
He said recipients of the vaccine will be closely monitored given reports of severe allergic reactions in a few individuals out of the more than five million people worldwide who have been inoculated. It is also possible that more adverse effects will emerge.
He said the vaccinations must be done by health professionals trained to recognize and manage adverse reactions. They should also have resources at hand to adequately respond.
Reporting of the patient’s response to the vaccine shall be through the pharmacovigilance system that will be activated once the vaccination program is implemented, Domingo added.
“The FDA commits to continue its job to ensure that Filipinos can have access to vaccines that hold greater benefits and outweigh the risk and possible adverse effects during this time of pandemic,” he said.
An EUA allows the use of a vaccine or drug that is still under development to respond to a public health emergency such as the Covid-19 pandemic.
Pfizer-BioNTech applied for an EUA in the Philippines on December 23, 2020. The United States, United Kingdom, European Union, Canada, Switzerland and Singapore have already issued an EUA for this vaccine.
The Pfizer vaccine is the only candidate vaccine against Covid-19 that has been issued an Emergency Use Listing (EUL) by the World Health Organization (WHO).
It is primarily aimed at preventing Covid-19 in individuals who are 16 years old and older. Prior to dilution, it has to be stored at -80 to -60 degrees Celsius.
Other companies that have filed for EUA in the country are multinational pharmaceutical company AstraZeneca, which submitted its application on January 6, and Gamaleya Research Institute of Russia, which applied on January 7.
Sinovac Biotech of China filed its EUA application before the FDA Wednesday afternoon, January 13.
As of Thursday morning, Domingo said the Vaccine Expert Panel reviewing the AstraZeneca Chadox1-S was scheduled to send within the day questions to clarify some clinical trial data.
AstraZeneca has an EUA in the UK, Argentina and India. Domingo said the panel hope to make a recommendation as soon as AstraZeneca responds to the questions.
Gamaleya has sent preliminary data on its Sputnik V candidate vaccine, but still has to submit some required documents. Sputnik V has an EUA in Russia, Argentina, Algeria, Bolivia, Serbia, Venezuela and Palestine.
Sinovac’s CoronaVac Sars-CoV-2 vaccine is undergoing pre-assessment, Domingo said.
The company has submitted the results of its phase 1 and 2 clinical trials. Domingo said they were awaiting data on its phase 3 trials.
“Until we see the clinical trials phase 3 results, we couldn’t assess it,” he added.
The Sinovac vaccine is expected to send its first shipment of 50,000 doses on February 20, followed by 950,000 doses in March, and two million to three million doses a month until December.
In a meeting with President Rodrigo Duterte Wednesday night, vaccine czar Carlito Galvez Jr. said a shipment of the Pfizer-BioNTech vaccine through the WHO's Covax initiative may also arrive in February. He did not elaborate.
Registration of a vaccine normally takes six months, but an EUA takes only 21 days. (Marites Villamor-Ilano / SunStar Philippines)