THE Food and Drug Administration (FDA) has allowed the use of the COVID-19 vaccine made by US firm Pfizer-BioNTech among minors aged 12 to 15 years old.
The FDA amended the emergency use authorization (EUA) earlier given to Pfizer, which allowed its use only for those 16 years and older.
The Department of Health said the amendment to Pfizer’s EUA would not affect the prioritization of vaccine recipients under the national vaccination program and does not mean the 12 to 15-year-olds would automatically be prioritized.
“While we welcome more vaccines that are approved for children and adolescents, due to limited vaccine supply, our vaccination strategy remains the same: prioritize the vulnerable and adhere to our prioritization framework,” Health Undersecretary Maria Rosario Vergeire said yesterday.
The new FDA move comes two weeks after the FDA announced that Pfizer has applied for an amendment of its EUA to include those aged 12 to 15 years. “This applies to the request for revision of the issued EUA to include individuals 12 years of age and older in its indication for active immunization for the prevention of COVID 19 caused by SARS-COV-2,” said FDA.
“The Pfizer-BioNTech COVID-19 vaccine shall be administered only by vaccination providers, and used only to prevent COVID-19 in individuals ages 12 and older,” added FDA.
Pfizer’s request for expanded EUA has also been granted by the US FDA.
Vergeire, in a radio interview earlier yesterday, said minors aged 16 to 17 but with comorbidities may be inoculated using Pfizer vaccines.
“If there is a teenager aged 16 to 17 and with comorbidities, he or she can be vaccinated with (Pfizer). They just need to present a medical clearance from their doctors,” said Vergeire.
There is no word yet if the same policy will apply for children aged 12 to 15.
To note, the national COVID-19 immunization program already covers priority groups A1 to A4 — healthcare workers, senior citizens, people with comorbidities, and workers.
FDA Director General Eric Domingo reported to the President on Monday night, that the agency has granted emergency use authorization to the Department of Health to accept the donations of the Sinopharm vaccine made by China.
Presidential spokesman Harry Roque said the EUA issued is just for the donations and a separate EUA should be applied for future purchase and use of Sinopharm vaccines.
The DOH on May 20 applied for the EUA for the donated vaccines after President Duterte said he would have the donation returned to China after some sectors questioned the legality of using the unregistered vaccine.
Malacañang said the donation was covered by the compassionate permit issued to the Presidential Security Group in February.
The donated vaccine was administered on the President last May 3. Roque said he is not aware if Duterte already received the second dose.
President Duterte on Monday night asked local government units (LGUs) to track down the people who have not received their second dose for COVID vaccine and convince them to be inoculated.
The President, in his weekly “Talk to the People” address, said while the vaccine does not guarantee against COVID-19, it is still an added protection against severe cases or death.
National Task Force (NTF) against COVID-19 chief and vaccine Czar Carlito Galvez Jr., in an interview with CNN Philippines yesterday, reiterated that around 113,000 individuals have missed their second vaccine shots, and for various reasons like being sick.
Health Secretary Francisco Duque III said those who failed to get their second shot on time can still get it.
The President urged the people to be patient, assuring them that the pandemic would eventually end.
Vaccine expert Lulu Bravo, in a briefing yesterday, said only 3 percent of those who have received the vaccines reported experiencing adverse effects, with high blood pressure as the worst.
Bravo, executive director of the Philippine Foundation for Vaccination, said other side effects experienced by those who received the jabs either from Sinovac, Pfizer, AstraZeneca or Gamaleya are chills, fever and being lethargic, which she said are all normal.
“In our almost three months of monitoring, we have not seen any negative effects of the vaccine. No red flag, no bad signal. Of course, there are adverse events. Almost 3 percent were reported,” she said in mixed Filipino and English.
Galvez, on Monday night reported to the President, that the delivery of 100,000 doses of Sputnik V vaccines from Russia’s Gamaleya Research Institute has been moved. No update was available as of press time.
Galvez also said the country is expecting a million doses of Sputnik V vaccines this month.
He said the country expects the delivery of 11.158 million doses of vaccine in June including the 5.5 million doses from Sinovac Biotech, 2.28 million doses of Pfizer and 2 million doses of AstraZeneca through the COVAX Facility and 250,000 doses of Moderna.
Galvez said the vaccination program slowed down last week due to the lack of vaccine delivery from the fourth week of May to the first week of June. He expects it to again pick up with the arrival of the vaccines soon.
A total of 1.52 million persons have received the two doses of vaccines.
Galvez said he still expects a happy Christmas this year, confident that the country will be able to achieve its targets such as 500,000 to 740,000 jabs per day to achieve population protection by November and eventually herd immunity by the end of the year.
Sen. Panfilo Lacson said government should be transparent on how it spent the P82.5-billion budget for the purchase of COVID-19 vaccines before asking for an another P25 billion for the purchase of additional jabs.
In a virtual press conference, Lacson said the government should present an itemized report of the vaccine purchases since asking for an additional P25 billion for vaccines would now cost the government a total of P107.5 billion.
Lacson said the government does not present an itemized report during its regular press briefings since the money it is asking may be more than enough to purchase vaccines to attain herd immunity.
Based on his computation, Lacson said if the government spent all of the P82.5 billion to purchase Moderna vaccines (priced at $26.83 or P1,283 per dose) it could already buy 83.7 million doses.
If the government purchased Sinovac (priced at P683 per dose), it could have bought 157.3 million doses more than enough to inoculate 70 million Filipinos with two doses so the country can achieve her immunity.
He said his computation is on top of the vaccine purchase of the private sector, which he said was at P22.8 billion for 17 million doses; and the vaccines which were given to the country through the COVAX Facility.
He said he does not want a repeat of the wrong pricing presented by the Department of Health for the purchase of vaccines when the Senate was deliberating on the 2021 national budget.
It can be recalled that the DOH initially said that the Sinovac vaccines was priced at P3,629 for two doses, but Lacson said the same vaccine brand was priced much lower in Thailand.
He said he computed the prices in the Philippines and Thailand which he said had a difference of P52.5 billion.
He said the additional P25 billion asked by the government for the purchase of vaccines “could result in an oversupply of vaccines, or worse, be lost to corruption.”
“Based on the arithmetic I did, the P107 billion is way too much for buying the vaccines needed to achieve herd immunity–unless they know something we don’t. But the bottom line is, it is not their money. It’s the public’s. I can only hope the excess amount will not go to corruption,” Lacson said.
Lacson said it is also important for the government to be transparent if it has made commitments to purchase the additional vaccines and how much. — With Jocelyn Montemayor and Raymond Africa
