Pfizer announces COVID-19 vaccine is 95% effective in final data, to seek authorization

Marje Pelayo   •   November 19, 2020   •   435

Pharmaceutical giant Pfizer announced Wednesday (November 18) that its trial vaccine for coronavirus disease (COVID-19) is now 95 percent effective after completion of a phase 3 study. 

The company said that primary efficacy analysis demonstrates vaccine candidate ‘BNT162b2’ to be 95 percent effective against COVID-19 beginning 28 days after the first dose.

Efficacy was consistent across age, gender, race and ethnicity demographics; observed efficacy in adults over 65 years of age was over 94 percent, the report said.

Also, the vaccine achieved the safety data milestone required by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA), Pfizer said.

To date, no serious safety concerns related to the vaccine candidate have been reported with the trial of the vaccine.

Both companies plan to submit within days to the FDA for EUA and share data with other regulatory agencies around the globe.

They expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.

Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world.

FDA clarifies donated vaccines require authorization, evaluation

Marje Pelayo   •   January 21, 2021

MANILA, Philippines — The Food and Drug Administration (FDA) issued a statement on Wednesday (January 21) clarifying that donated COVID-19 vaccines still require FDA authorization in the form of Emergency Use Authorization (EUA) prior to use.

The statement came after some senators in a recent Senate hearing, raised concerns on the issue of donated vaccines from China.

The FDA said, “Entities which intend to donate vaccines to the government are required to coordinate with the Department of Health (DOH) which will facilitate the acceptance and processing of the donation.”

The agency further noted that the proposed donations will be evaluated by the DOH in consideration to the need of beneficiaries, reliability of the source shelf life and other relevant criteria.

“Only after authorization of the FDA may the DOH distribute the products to the intended beneficiaries,” FDA said.

FDA stressed that “the approval of the donated product does not mean free use thereof. FDA’s authorization is limited to the donated lot and carries conditions for use depending on the nature of the donated product.”

The DOH is also mandated to take full responsibility for the use of the donated vaccines, given that the product has been granted EUA by the FDA which ensures its safety, quality and efficacy. MNP/Raymund David

Lacson accepts Galvez’s apology over ‘politicizing’ remark on COVID-19 vaccine issue

Robie de Guzman   •   January 21, 2021

MANILA, Philippines – Senator Panfilo Lacson on Thursday said he has accepted the apology of vaccine czar and National Task Force against COVID-19 chief implementer, Secretary Carlito Galvez Jr. for his previous remark accusing some senators of politicizing the government’s COVID-19 vaccination program.

“I accepted his apology. He promised to be more careful in issuing statements,” Lacson said in a statement.

The senator said Galvez apologized during a meeting with him, Senate President Vicente Sotto III, Senator Ronald dela Rosa, and contact tracing czar Baguio City Mayor Benjamin Magalong on Wednesday.

But prior to their meeting, Lacson said he received a message from Magalong, relaying Galvez’s request to meet with him to apologize for his remarks during virtual meeting last week.

“He also promised to brief me and disclose all the details of their vaccine procurement, including the prices of the different brands,” he said.

“Then came the instruction of President Rodrigo Duterte to Sec. Galvez to brief Senate President Vicente Sotto III. I suggested to them that SP Sotto and I just go together, along with Sen. Ronald de la Rosa,” he added.

During the meeting, Lacson said that Galvez was able to clarify “a lot of issues and concerns raised by senators that have remained unresolved until last night.”

“We advised him to explain in tomorrow’s hearing the same way that he did last night, without violating the terms of the agreement with the vaccine suppliers,” he added.

The Senate is set to resume its inquiry on Friday, January 22 on the government’s nationwide immunization plan.

Lacson said he was satisfied with Galvez’s briefing but advised the official to be vigilant against any irregularity that may be taking place without his knowledge.

“We were shown the documents. And we have no doubt about Sec. Galvez’s integrity and his sincerity to accomplish his task,” he said.

“That said, we advised Sec. Galvez to mind his back, front, left and right sides. He may have the best of intentions but there may be people pushing him out front to do the talking and explaining to take advantage of his credibility while pursuing their own interests,” he added.

Lacson said that Galvez has assured senators that he will make it “very hard for those people to even have an opening for that opportunity.”

India’s Bharat Biotech applies for EUA in Phl for COVID-19 vaccines

Aileen Cerrudo   •   January 21, 2021

MANILA, Philippines — Indian biotechnology company Bharat Biotech has applied for Emergency Use Authorization (EUA) in the country for its COVID-19 vaccine.

The Food and Drug Administration, in a message, has confirmed that Bharat Biotech submitted their application for Covaxin on Wednesday (January 20) and pre-evaluation is already ongoing.

“They submitted an application this morning and pre-evaluation is going on,” according to FDA Director-General Eric Domingo.

Meanwhile, in a statement, the biotech company said that Covaxin is ideal for tropical countries because storage temperature only needs to be set by two to eight degrees celsius.

Bharat Biotech also said the Philippines is among the list of priority countries that will receive Covaxin supply.

“The Philippines is among the list of priority countries that Bharat Biotech will allocate supplies of Covaxin to. It was announced earlier this week that the Indian government has issued a letter of comfort covering this,” the company said in a statement.

Other companies seeking EUA in the country include Astrazeneca, Gamaleya Research Institute, and Sinovac Biotech. -AAC (with reports from Aiko Miguel)

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