Pfizer vaccine gets FDA nod

CEBU, Philippines —  In an unprecedented move this pandemic, the Food and Drugs Administration (FDA) yesterday announced the approval of the emergency use of Pfizer-BioNTech vaccine against COVID-19 in the country even as it is still in its development stage.

FDA Director General Eric Domingo, in a virtual presser over the Department of Health’s Facebook page, said the FDA has issued an emergency use authorization (EUA) to the company, which was also the first to obtain such permission in the United States.

Through Executive Order No. 121 s. 2020, vaccines under development can be granted an EUA where there is no adequate, approved and available alternative to a vaccine for preventing COVID-19.

Evaluation was reportedly based on current available data. The likes of U.S.A, United Kingdom, the European Union, Canada, Switzerland, and Singapore have also issued EUA to Pfizer-BioNTech and the World Health Organization with an emergency use listing procedure.

Pfizer-BioNTech applied for an EUA in the Philippines last December 23.

The other vaccines awaiting action on their EUA applications in the country are Astrazenic-Chadox1-S (Recombinant), which applied last January 6, Gamaleya-Sputnik V Gam-Covid-Vac (January 7) and Sinovac-Coronavac Sars-Cov-2 vaccine (Vero cell) which is for re-assessment.

Vaccine czar Secretary Carlito Galvez Jr. said only FDA-approved vaccines, whether for an EUA or for clinical trials, will be used in inoculating Filipinos. Regardless of the brand names or country of origin, all vaccine candidates, he added, will undergo the same rigorous regulatory review procedures.

Adverse reactions

Interim data from the ongoing Phase 3 trial shows that the Pfizer-BioNTech vaccine has an efficacy of 95% in the study population and at least 92% among all racial groups.

Adverse events following immunization, he added, shall be closely monitored.

“The rollout of the vaccine and use in more than 5 million people worldwide has identified severe allergic reaction in a few individuals. Therefore, the vaccinations must be done by health professionals trained to recognize and manage adverse reactions and they should have resources at hand to adequately respond” Domingo said.

In his presentation, Domingo said it would be best to be vaccinated in a facility that has capabilities to monitor, manage and detect possible allergic reactions and by trained health care workers.

He added that the vaccine is not for all ages, but for 16 years old and above and cold chain have to be on an acceptable range.

“Ang particular concern talaga natin is the cold chain, minus 70, minus 80, so probably, talagang magagamit ito sa hospital where they have the facility for it and ability to store it properly,” said Domingo.

Department of Health-7 spokesperson Dr. Mary Jean Loreche said yesterday that no vaccine is without adverse reactions 100% just as no vaccine renders 100% efficacy.

For vaccination purposes, Loreche said these things must be considered: medical history on allergies; whether one is immunocompromised; whether those with medical conditions have been screened well; close monitoring for any adverse reactions; and proper planning prior to vaccination.

Definitely, Loreche said, any vaccine can have an adverse reaction as each individual has different ways of reacting to a foreign substance introduced to the body.

“The mRNA is considered by the body as foreign and this is the reason why antibodies are produced,” she said.

Information campaign

Meanwhile, health experts cited the need for an information campaign to increase vaccine confidence among Filipinos amid concerns over efficacy of vaccines.

Infectious disease expert Dr. Bryan Albert Lim emphasized the need for the local government units and the national government to increase confidence among Filipinos by educating them about the whole vaccination process.

Loreche also pointed out the importance of educating people and the need to cascade the information about vaccination.

DOH-7 Director Dr. Jaime Bernadas said health units across the country, including those in the municipal and barangay levels, have a crucial role to play in vaccination implementation.

Bernadas added the government has already started the trainer's training to prepare the country's health system for the vaccination.

In Cebu City, Councilor Alvin Dizon has requested the City Health Department to launch a massive COVID-19 vaccine public information/education drive using all platforms and tap the mass media to educate people about the inoculation.

He likewise requested CHD to undertake the education drive in coordination with the Association of Barangay Councils (ABC) and Sangguniang Kabataan Federation (SKF) and, if need be, to form a barangay-based task force to address vaccine confidence down to the community level.

Dizon also requested the Committee on Laws and Ordinances to render a report on the proposed ordinance entitled “An Ordinance Establishing the COVID-19 Vaccination Program (CVP) of Cebu City, providing funds thereof and for other purposes”, which he authored.

“Vaccinating the population is extremely urgent and life-savingly important, because the sooner the target for herd immunity can be reached, the sooner the economy can fully reopen and a better normal way of life can resume,” he said.

Effective vs New Variants?

After Wednesday’s confirmation of the first known case of the UK variant of the coronavirus in the Philippines, a question that begs an answer now is whether the existing vaccines can be used against such and other variants of the virus.

“There is an ongoing study of the manufacturers nung Pfizer-BioNTech vaccine sa laboratory. They were able to show that the vaccine can still work against the current mutation. Nagkaroon pa rin ng production ng antibodies against the virus na nasa laboratory,” said Dr. Issa Alejandria, head of the of the Philippine Society of Microbiology and Infectious Diseases (PSMID).

Dr. Edsel Salvana from the UP National Institutes of Health also said the vaccines that are being developed remain effective even with the new mutations.

“For now, yung ating mutations na nakikita are not expected to affect the vaccine efficacy because konti pa lang po yung mutation,” he said.

‘Premature’

Meanwhile, for Governor Gwendolyn Garcia, it's "premature" for Cebu to purchase COVID-19 vaccines, especially that the national government has already set aside a huge fund for the procurement of the vaccines.

The governor noted the statement of Galvez that the national government is purchasing 148 million doses of such vaccines in 2021.

Garcia, however, said the province will step in if there's a need to procure more vaccines.

“And even the fact that there is really a such already an urgent need to fill in the short fall, 70 million naman gud ang ma-cover ana. That’s 70 million Filipinos, that's about 70 percent of our population, then kung kinahanglan gyud nga katong 30% LGU na ang mo fill in, anha pa ta mag-estimate og budget oy,” Garcia said.

“My position lang, it's premature, it's not a race. Di man gud na lumba kay kung kaya na nga makahulat ta, kay wala pa man sad gyud na nga mga vaccine,” she added.

She also cited the current protocol in which LGUs cannot directly purchase the vaccines, since there's a need to enter first a tripartite agreement with the supplier, the national government and the LGU. — Ruth Malinao, JMD (FREEMAN)