THE Food and Drug Administration (FDA) yesterday said it has granted emergency use authorization (EUA) for COVID-19 vaccines of the Indian firm Bharat Biotech International Limited and American company Johnson & Johnson.
“Overall, the benefits of using these vaccines outweigh the potential risks,” FDA Director General Eric Domingo said in a briefing.
Bharat Biotech applied for an EUA for its Covaxin on January 22 and Johnson & Johnson’s unit Janssen, on March 31. Both vaccines can be administered to people aged 18 and older.
The two are the fifth and sixth to be issued EUAs. The first four are the US’ Pfizer-BioNTech, British-Swedish firm AstraZeneca Plc, China’s Sinovac Biotech, and Russia’s Gamaleya.
Domingo said Bharat was given a “conditional” EUA as the company has yet to submit all documentary requirements.
“They just have to submit their certificate of good manufacturing practice before importing the products,” he said.
Bharat’s vaccine, which is given in 2 doses 14 days apart, reportedly has an 80.6 percent efficacy rate.
As for Janssen, Domingo said the EUA was given amid investigations over possible links to blood clotting in the United States.
“Even if it is found later to be connected to the vaccine, the 1% per 1 million adverse event does not outweigh the number of those that can be protected when they are vaccinated,” he said.
“If the DOH will use it, there has to be clear guidelines and safeguards, such as clear signs and symptoms that need to be monitored,” added Domingo.
Janssen’s vaccine, which is a single dose jab, has an efficacy rate of 66 percent.
J&J is conducting late-stage clinical trials for its COVID-19 vaccine in the Philippines.
The National Adverse Events Following Immunization Committee (NAEFIC) said it will not hesitate to recommend the suspension of the immunization program if there is ground to do so.
NAEFIC data shows that as of April 13, there were 25,661 (2.04%) reported AEFIs out of 1,255,716 vaccinees nationwide.
Of the AEFIs, 2.013 percent are classified as non-serious, while the other 0.030 percent are classified as serious.
The most common AEFIs are blood pressure increase, fever, headache, vaccination site pain, dizziness, and chills.
“When we see a causality that shows there seems to be an increase or clustering of (adverse) events, then we can make our recommendation to the DOH and the FDA,” said NAEFIC member Dr Eileen Cuajunco.
“As of now, we haven’t seen such a need so we haven’t given any statement on that,” she also said.
VACCINE ARRIVALS
The Philippines is set to receive the first 200,000 doses of Moderna vaccines, out of 20 million doses bought by the Philippines, by middle of June, Ambassador to the United States Jose Manuel Romualdez said.
“They were able to just get some vaccines that were available. This will come from Europe, not the US, So, we were able to secure something like close to 200,000 from Moderna that will be delivered there sometime around middle of June. But I said, the biggest delivery is starting July, August, September,” Romualdez said in mixed Filipino and English.
He said that during his discussions with the American vaccine manufacturer, Moderna also talked about “booster shots” that are being developed and undergoing clinical trials.
On Pfizer vaccines, Romualdez said the delivery of about 117,000 doses under the World Health Organization-led COVAX Facility will “hopefully” be next month.
He said delivery is delayed due to legal issues concerning indemnity clause. He said negotiations are in the final stage.
Vaccine czar Carlito Galvez Jr., chief implementer of National Task Force against COVID-19, on Monday night said at least 14 million doses of vaccines bought from different firms are expected to arrive until the end of the second quarter of the year with majority of the vaccines coming from Sinovac and Gamaleya.
Galvez said despite limited global supply, the government will continue to receive vaccines from at least four manufacturers in the second quarter.
The country expects a steady supply of about 10 million to 15 million doses a month from July to December.
Galvez said the expected vaccines do not include donations from Pfizer and AstraZeneca under the COVAX Facility, which are expected to arrive this month.
President Duterte, on Monday night, said the government’s vaccination program is “more than an acceptable performance in the matter of the fight against COVID as far as the Philippines is concerned.”
He said criticism that the government’s slow vaccination program is “unfounded.”
“As you can see, we are not the weakest and our ranking and it goes to show that we are really working very hard, especially Secretary Galvez to get the vaccines here in the Philippines on time,” he said in mixed English and Filipino. He was referring to the Department of Health’s pronouncement on Monday that Philippines ranks third among Southeast Asian countries with the most number of vaccinated individuals.
INFO DRIVE
Rep. Elpidio Barzaga Jr. (NUP, Cavite) said the government has to fight COVID-19 vaccine hesitancy to safeguard the lives of citizens, citing the Constitution’s General Welfare clause which states that the State is mandated to protect the lives of the majority.
Barzaga, the president of the National Unity Party (NUP), urged the Department of Health, the Department of Interior and Local Government, and medical professional groups to step up their information campaign to boost the people’s confidence in COVID-19 vaccines by holding regular webinars to be aired on government television stations.
He said a person who is not vaccinated against the disease “is a risk to the lives of others and to the general community.”
“COVID-19 is real and it has come closer to home. It has touched all of us, where every one of us has a parent, sibling, relative, friend, co-worker who has been infected by this deadly virus. There is no way to know how COVID-19 will affect an individual. A person can only have mild symptoms of cough and fever but to the unfortunate one, it can be serious and life threatening,” he said in a statement.
He lamented many are still hesitant to be vaccinated even if it the best way to protect themselves and their loved ones from COVID-19. — With Jocelyn Montemayor, Wendell Vigilia and Reuters
