February 15, 2021 — Food and Drug Administration Director-General Dr. Rolando Enrique Domingo announced the government’s plan to vaccinate 70 million Filipinos within 2021 with vaccinations to start possibly as early as February or early March. He made this announcement during the Stop COVID Deaths Webinar Series entitled, “Are We Ready for COVID-19 Vaccines?” held on 22 January 2021 to discuss the country’s readiness in terms of our vaccine deployment and preparedness.
He announced the inclusion of the Philippines in the COVAX facility and the country will receive 14 million doses from this. The COVAX facility is a way for countries to pool resources and to have an equitable distribution of COVID-19 vaccines. To achieve the 70 million target, Dr. Domingo stressed that the government is making arrangements with other manufacturers to achieve the herd immunity threshold of 70% of the population.
With vaccine development usually taking many years, Dr. Domingo disclosed that most of the leading vaccine development efforts are still in the middle of phase three clinical trial which means they are not eligible for the certificate of product registration (CPR). To make the vaccine available in the country during this pandemic, Executive Order 121 was signed on Dec. 1, 2020 granting the FDA the authority to issue an Emergency Use Authorization (EUA) for COVID-19 vaccines. EUA is a risk-based procedure to assess an unlicensed vaccine along three criteria: evidence showing the vaccine’s effectiveness against COVID-19, potential benefits outweighing the risks, and no currently available approved COVID-19 vaccine. He stressed that EUA is not a marketing authorization which means that the vaccines given EUA cannot be sold commercially.
The FDA assured the public that it will do its best to make sure that the vaccine that will be given emergency authorization will pass through all the needed scientific and technical reviews. Quality and production stability will be reviewed by regulatory officers in FDA and the scientific safety and efficacy data will be evaluated by two expert panels composed of at least five members who are infectious disease specialist, immunologists, vaccine specialists, and epidemiologists.
“The good thing about the EUA is that the Director General has the discretion to review, revisit, and revoke authorization at any time if there are any serious safety concerns. Comprehensive pharmacovigilance system is shared equally by the manufacturer and both DOH and FDA. Monitoring and surveillance will be very strict and we’re now rolling out training programs,” stated Dr. Domingo.
According to Dr. Domingo, Pfizer-BioNTech was granted EUA while Astra Zeneca, Gamaleya Sputnik V, and Sinovac are under evaluation. He disclosed that Moderna, Serum Institute of India, Bharat Biotech, Janssen of Johnson and Johnson, Clover, and Sinopharm are also asking for the requirements and will soon be applying for the EUA. Aside from the EUA, Dr. Domingo disclosed that the FDA approved COVID-19 vaccine clinical trials of Janssen of Johnson and Johnson and Clover Pharmaceutical in the country.
Dr. Eric Tayag, Director IV of the DOH Knowledge Management and Information Technology Service discussed that since there are several brands of vaccines on cue that may be given EUA, this implies potential use of different brands of vaccines in the country. The challenge is not only providing specific logistical arrangements but also the correct information so that those who will vaccinate will know the exact procedure for these diferent vaccines.
Dr. Franco Felizarta, infectious disease and internal medicine specialist shared his experiences on being vaccinated in the United States. He said that hospitals who were supposed to give the vaccine to all health care workers were overwhelmed. For their vaccination program, they sought the help of the community health centers, private clinics, and pharmacies. He also described the complex logistical requirements of vaccine distribution since some of the vaccines require a -70 degree freezer and the need for online appointments since most vaccine vials contain multiple doses.
Mr. Roby Alampay, co-anchor of “The Chiefs” on TV5 One News asserted that the information campaign should not be limited to the digital world but needs to be expanded. He asserted that other ways could be traditional like door-to-door campaign, town hall meetings, use of pamphlets, and going down to the communities.
From the private sector’s perspective, Mr. Paolo Maximo Borromeo, President and CEO of Ayala Healthcare, expressed full support for the government and pushed for the procurement of these vaccines at the soonest time.
“The readiness for COVID-19 vaccine is a whole of society approach whether one is from the private sector or the public sector or just part of the general public. We all have a role to play to make sure that we are all ready,” emphasized Chancellor Carmencita Padilla.
Charmaine Lingdas
Published in UP Manila Healthscape Special COVID-19 Issue No. 23
