By Teodoro B. Padilla
The government aims to roll out the distribution of coronavirus disease 2019 (COVID-19) vaccines to the public by the end of February. Priority populations for COVID-19 vaccination are healthcare workers, the elderly, indigents, and uniformed personnel, among others.
In January, the Philippine Food and Drug Administration (FDA) granted its first Emergency Use Authorization (EUA) to the Pfizer-BioNTech COVID-19 vaccine. President Rodrigo R. Duterte — through Executive Order No. 121 s. 2020 — gave the FDA the authority to issue EUA for vaccines under development where there is no adequate, approved, and available alternative to a vaccine for preventing COVID-19 during this present public health emergency. The EUA is not a marketing authorization or a Certificate of Product Registration, and therefore cannot be used to market the vaccine commercially.
The EUA was granted after a careful evaluation of current available data on the Pfizer-BioNTech COVID-19 vaccine. A panel of clinical experts reviewed the vaccine’s safety and efficacy, and technical experts from the FDA Center for Drugs Regulation and Research reviewed the quality data. “The interim data from the ongoing phase 3 trial shows that the vaccine has an efficacy of 95% in the study population and at least 92% among all racial groups,” FDA Director-General Dr. Rolando Enrique D. Domingo said in a press statement.
Just last week, the FDA approved the AstraZeneca COVID-19 vaccine for emergency use, making it the second COVID-19 vaccine in the country to be granted EUA. The vaccine has an average efficacy of about 70% after two full doses. The vaccine had no safety concerns and its adverse effects were “transient and mostly mild to moderate, similar to common vaccine reactions,” Mr. Domingo said. The COVID-19 vaccine of AstraZeneca can be transported and handled at normal refrigerated conditions of between 2°C and 8°C for at least six months.
Biopharmaceutical companies are at the forefront of global efforts to develop safe and effective COVID-19 vaccines and to scale up manufacturing to ensure equitable access to people around the world. As of Jan. 26, the World Health Organization (WHO) reports 63 candidate vaccines in clinical evaluation and 173 candidate vaccines in preclinical evaluation. Companies are collaborating on an unprecedented scale to extensively scale up the production capacity of COVID-19 vaccines.
Biopharmaceutical companies are sharing real-time clinical trial data with governments and other companies around the world to advance the development of additional COVID-19 therapies. They are rapidly screening the industry’s vast libraries of medicines to identify potential treatments and undertake numerous clinical trials to test new and existing therapies. They are also sharing tools and insights to test potential therapies and vaccines as well as to develop and scale up the capacity of diagnostics testing for COVID-19 patients as much as possible.
The Pharmaceutical and Healthcare Association of the Philippines (PHAP) fully supports the government’s COVID-19 vaccination program under the Department of Health (DoH) and the Inter-Agency Task Force. An urgent challenge we need to address is vaccine hesitancy, or the delay in acceptance or refusal of vaccines despite the availability of vaccine services. The WHO considers vaccine hesitancy as one of the 10 threats to global health that demand attention from the organization itself and its health partners.
The DoH has pointed to vaccine hesitancy as one of the reasons for the 2019 measles outbreak in several regions of the country. Moreover, DoH data reveal that the country’s immunization coverage has been declining in recent years. There is an urgent need for all concerned stakeholders to unite in increasing the country’s immunization coverage and restoring public trust and confidence in vaccines, especially in this time of pandemic.
The COVID-19 pandemic is one of the most daunting public health challenges we have faced in recent history. However, COVID-19 is not the only health threat in our midst. This is why the industry is working to continue research and secure continuity of supply for all essential medicines, vaccines, and diagnostics for patients with other life-threatening diseases.
Teodoro B. Padilla is the executive director of the Pharmaceutical and Healthcare Association of the Philippines (PHAP). PHAP and its member companies represent the research-based pharmaceutical sector in the country.