Philippines OK’s Pfizer vaccine emergency use

By Vann Marlo M. Villegas Reporter
and Kyle Aristophere T. Atienza

THE PHILIPPINES approved the emergency use of Pfizer, Inc. and BioNTech’s coronavirus vaccine, the first in the country, as infections neared 500,000 on Thursday.

The local Food and Drug Administration (FDA) issued the authorization for the vaccine, which has a 95% efficacy, Director General Rolando Enrique D. Domingo told an online news briefing.

“After a thorough review of the currently available data by medical and regulatory experts, the FDA today is granting an emergency use authorization to Pfizer-BioNTech COVID-19 vaccine,” he said.

The benefits of the vaccine, which requires -80 to -60 degree Celsius storage before dilution, “outweighs the known and potential risks,” Mr. Domingo said, adding that there is evidence that the vaccine “may be effective to prevent, diagnose, or treat COVID-19.”

The Department of Health (DoH) reported 1,912 coronavirus infections on Thursday, bringing the total to 494,605. The death toll rose by 40 to 9,739 while recoveries increased  by 746 to 459,252, it said in a bulletin.

The FDA chief said side effects were “transient and mostly mild to moderate, similar to common vaccine reactions,” he said. There were also no specific safety concerns. Patients will be closely monitored after immunization, he added.

Mr. Domingo said the vaccine may  be given to people aged 16 years and above.

Vaccine czar Carlito G. Galvez, Jr. on Wednesday said the government might use the Pfizer vaccine in the early rollout under the COVID-19 Vaccines Global Access (COVAX) facility of the World Health Organization (WHO).

About 40 million doses will come from the COVAX facility for 20 million to 30 million people, Mr. Galvez earlier told senators.

COVAX, co-led by Gavi, the Vaccine Alliance, Coalition for Epidemic Preparedness Innovations and the World Health Organization, aims to ensure the availability of COVID-19 vaccines to all countries.

China’s Sinovac Biotech Ltd. also submitted its application for emergency use on Wednesday.

Mr. Domingo said the vaccine, which China had authorized for emergency use, was still being assessed given incomplete clinical trial data.

UK-based drug maker AstraZeneca Plc and Russia’s Gamaleya Research Institute of Epidemiology and Microbiology have also applied for emergency use.

DoH said there were 25,614 active coronavirus cases, 85% of which were mild, 6.4% did not show symptoms, 5.2% were critical, 2.9% were severe and 0.48% were moderate.

Davao City reported the highest number of new cases at 136, followed by Quezon City at 107, Agusan del Sur at 61, Dagupan City at 57 and Cavite at 54.

DoH said five duplicates had been removed from the tally, while 14 recovered cases were reclassified as deaths. Seven laboratories failed to submit their data on Jan. 12. About 6.7 million Filipinos have been tested as of Jan. 12, according to DoH’s tracker website.

The coronavirus has sickened about 92.8 million and killed about two million people worldwide, according to the Worldometers website, citing various sources including data from the World Health Organization. About 66.4 million people have recovered, it said.

ASTRAZENECA
Also on Thursday, the government signed a deal with local government units (LGUs), private sector donors and AstraZeneca Plc for 20 million more orders of the drug maker’s coronavirus vaccines.

The deal, led by presidential adviser for entrepreneurship Jose Maria A. Concepcion, involves about 300 companies and 30 local governments.

He said the country would not be left behind in the global fight against the coronavirus. “We will be vaccinating our Filipino people hopefully starting June or July,” he said at the signing ceremonies.

“You have my full support,” President Rodrigo R. Duterte said in a speech at the event. “This is Bayanihan at work,” he added, referring to the spirit of civic unity among Filipinos.

More than 30 members of the private sector in November committed to donate 2.6 million doses of AstraZeneca’s coronavirus disease 2019 (COVID-19) vaccine.

“AstraZeneca maintains our strong commitment to ensuring equitable access to the vaccine at no profit for the duration of the pandemic,” AstraZeneca country President Lotis C. Ramin said during the program.

The British drug maker is working closely with regulatory authorities to ensure that the COVID-19 vaccine lives up to the highest safety standards and its introduction complies with healthcare regulations in the Philippines,” she said.

Also on Thursday, health groups called for a more “comprehensive, equitable and transparent COVID-19 vaccine rollout.”

In a statement, the Coalition for People’s Right to Health sought full government regulation of vaccines, medicines, and technologies, and for voluntary clinical trials.

It also said emergency use authorization should not be given to a vaccine without preliminary phase three clinical trials, due to efficacy and safety issues.

The health advocates also called on the government to support a global waiver of patent enforcement on COVID-19 vaccines and remove taxes and tariffs on vaccine imports.