FDA may give vaccine approval in January

Vaccination seen in March

The government may issue authorization for emergency use of COVID-19 vaccines by January to jumpstart a massive immunization program by March or earlier, according to the Food and Drug Administration.

FDA director general Eric Domingo said the agency can possibly grant emergency use authorization (EUA) by January or within 21 to 28 processing days upon submission of the necessary requirements.

“So it depends on production, if there is enough supply that can be delivered to us. The approval (of EUA) will come first,” Domingo said in Filipino at a virtual press briefing yesterday when asked if COVID-19 vaccines would be

available in the first quarter of 2021.

Next week, Domingo said the FDA would come out with the guidelines for the submission of requirements for EUA.

Domingo said among the vaccines that would be made available locally were from manufacturers that were able to secure EUA from their countries of origin like Pfizer, Moderna and Sinovac.

“We would like to assure the public that the benefits will outweigh the risks and more than anything before the granting of EUA, there will be lot of conditions to safeguard the safety of the public,” Domingo said.

The FDA chief expressed optimism that the vaccines would be available earlier than expected after the United Kingdom granted EUA for COVID vaccine produced by Pfizer. There are also reports that US is also set to issue EUA for COVID vaccines within one to two weeks.

Aside from pharmaceutical companies, the national government may also apply for EAU, Domingo also said.

He said the national government – through the national procurer or public health implementer – can apply for EAU, which would be granted if controlled trials show benefits of the vaccine or treatment outweigh the risks.

“EUA is a risk-based way of evaluating whether vaccines not yet licensed can be used in time of pandemic,” he explained in Filipino.

“The applicant must also guarantee the government that it will complete the vaccine or drug development process until they reach full application and licensing,” he added.

After obtaining EUA, Domingo said vaccine manufacturers are expected to apply for local EUA so they can immediately supply their products to the Philippines.

Voluntary

Domingo stressed that nobody would be forced to get the vaccine if they do not want to. Those to be vaccinated should be well informed of the benefits and the possible risks of the vaccine, he said.

Thus, he said the Department of Health (DOH) is mounting an information campaign on the risks and benefits of vaccines.

He said the FDA and the DOH would also be closely monitoring those vaccinated so that possible complications can be immediately investigated and addressed.

“One of the basic requirements for vaccine is a strong surveillance system,” he said.

But in an interview with “The Chiefs” on One News, Health Undersecretary Maria Rosario Vergeire said the DOH is coordinating with the Department of Justice (DOJ) on a mandatory implementation of COVID vaccination.

“We are coordinating with the legal services as well as of course the DOJ, (to) bring this forward so we will be guided on how we can be able to implement this without violating the rights of any individuals, but at the same time push the objective of public health,” Vergeire said.

“We will be getting informed consent, but if people will refuse to accept the vaccine it might defeat the purpose. If we try to look at the very objective of immunization, we would want to have the herd immunity so we can protect the whole population,” she added.

Vergeire said mandatory vaccination is actually not new as there is an existing law requiring immunization of all children less than a year old.

“Based on the law mothers are mandated to bring their children to health facilities for vaccination, but of course there is still the consent because they won’t bring their children if they really do not like,” Vergeire explained.

But she said a recent survey indicated that almost 60 percent of respondents were interested and willing to receive the COVID-19 vaccine.

She said clear implementing guidelines for COVID vaccination program are essential.

Currently, Vergeire said the DOH and all other concerned agencies are exerting efforts to meet the timeline set by President Duterte for massive COVID-19 vaccination.

Last Tuesday, Duterte signed Executive Order No. 121 allowing the FDA director general to issue EUA.

Domingo said the primary requirement for applications is an equivalent EUA issued by applicants’ countries of origin, specifically by a stringent regulatory authority, or by the World Health Organization.

Once the applicant presents the requirement, the Philippine FDA will come up with a list of its own requirements. Domingo said an expert panel composed of vaccine, immunology and infectious disease experts would examine the data presented by the applicants and then decide whether an EUA should be issued.

Presidential spokesman Harry Roque reminded the public to continue observing health measures like physical distancing, frequent hand washing, and wearing of face masks and face shields while waiting for the arrival of the vaccine.

The government is planning to borrow P73.2 billion to buy vaccines for 60 million Filipinos.

Vaccine protocols

With massive immunization against COVID-19 now on the horizon, Rep. Ronnie Ong of party-list Ang Probinsiyano said it would be best for the government to release vaccine protocols to ensure smooth implementation of a vaccination program next year.

“We have to be very proactive this time. We have to set up the system this early and establish the best practices and protocols for every foreseeable scenario,” Ong said.

The neophyte lawmaker underscored the need for a “comprehensive and detailed database of recipients,” and that the administration should act promptly “instead of doing lastminute preparations when the vaccine is already available.”

“Many of us are wondering as to the next concrete steps on the so-called life after the COVID-19 vaccine like where will the mass vaccinations be held? What are the possible side effects?” Ong asked.

“After the vaccinations, are those vaccinated allowed to forgo their masks and face shields? Can they travel already domestically and abroad? There are just too many questions, and hopefully these are answered soonest before the vaccine is administered,” he pointed out.

Ong said the Inter-Agency Task Force for the Management of Emerging Infectious Diseases (IATF) “should lay down to the public the required post-vaccination protocols and guidelines.”

“This is to prepare the public to a post-pandemic life. It should be made public at the soonest possible opportunity. This is to ensure that all sectors would have a walkthrough on what to expect from the government and from their community,” he said.

In a related development, Deputy Speaker Mikee Romero ( 1Pacman party- list) has filed a bill proposing a security program for the protection and safety of Filipinos against biological and nuclear threats.

“The threat of Chemical, Biological, Radiological, Nuclear (CBRN) materials and weapons is a global challenge. The Philippines, an archipelagic country with the vast coastline and porous borders, is vulnerable to different threats or risks to its population,” Romero said in House Bill 4458.

“The passage of this (CBRN) House Bill is earnestly sought to maintain the safety and security of the present and future generations of Filipino,” he added.

“If these materials are used malevolently, or if the laboratories or facilities containing these materials have not followed safety and security protocols, the probabilities of exposing the Filipinos and the environment to grave threats are increased,” he said.