BRITISH pharmaceutical firm AstraZeneca PLC yesterday became the second company to get an emergency use authorization (EUA) for its coronavirus disease (COVID-19) vaccine.
The first is Pfizer and BioNTech which was granted an EAU earlier this month by the Food and Drug Administration (FDA).
COVID-19 vaccines from Russia’s Gamaleya Institute, the Chinese private firm Sinovac Biotech, and India’s Bharat Biotech are awaiting approval.
In a televised public briefing, FDA Director General Eric Domingo said AstraZeneca was able to prove that its vaccine’s potential benefits outweigh possible risks.
“The interim data from the ongoing Phase 3 trials, when taken to its entirety, show that the vaccine has an efficacy of 70 percent after the first dose,” Domingo said.
With the EUA, AstraZeneca may provide vaccine supplies only to the Department of Health or the National Task Force, or whichever the two agencies authorize to procure COVID-19 vaccines, Domingo said.
He also said an EUA is not a marketing authorization or a certificate of product registration, so the vaccine will not be available commercially.
Domingo said the vaccine is composed of two equal doses to be given four to 12 weeks apart.
The vaccine may be provided only to adults aged 18 years and older.
Among its reported adverse effects, according to Domingo, are common vaccine reactions such as pain around the vaccinated area, mild fever, and headache.
Domingo also said AstraZeneca’s vaccine is easy to transport and store and does not require ultra-cold temperatures. “It also has very good protection against severe COVID-19,” he said.
The Philippines has signed deals to buy 17 million doses of AstraZeneca’s vaccine, including a private sector agreement for 2.6 million doses in November.
The initial shipment scheduled in May would not be affected by some manufacturing problems facing AstraZeneca, said Jose Concepcion, a government business adviser representing the private sector.
Domingo hinted that the remaining applicants for EUA may face a more difficult evaluation process.
He said Sinovac, Gamaleya, and Bharat “have no EUAs from stringent regulatory authorities so we are being more careful in our studies.”
He said the studies of the three firms have not been published in medical journals.
“So our experts are closely looking at the information and data they have presented to us.
We are also asking for clarificatory statements and more documents from them,” said Domingo.
Sinovac has EUAs from China, Indonesia, Turkey, and Brazil; Gamaleya from Russia, Argentina, and Belarus; and Bharat, from India.
The government is procuring 148 million doses of vaccines from seven companies, with the first batch from Sinovac, AstraZeneca and Pfizer (through the COVAX Facility) expected to be delivered next month.
Presidential spokesman Harry Roque said China’s Sinovac will deliver the first batch of vaccines by February 20 and the start of the administration of vaccines is expected around March.
Vaccine czar Carlito Galvez Jr. said Sinovac will deliver 500,000 doses while AstraZeneca and Pfizer are expected to deliver between 200,000 to 500,00 doses each also in February.
The World Health Organization’s Europe director Hans Kluge said on Thursday vaccine manufacturers were working non-stop to plug shortfalls in supplies to countries struggling to curb the COVID-19 pandemic and urged them not to jostle for deliveries.
“Solidarity does not necessarily mean that each country in the world starts (vaccinating) at exactly the same moment … The good understanding is that no one is safe before everyone is safe,” Kluge told an online news briefing.
Asked about delays in expediting Pfizer and AstraZeneca vaccines to patients across the 27-nation European Union, Kluge said governments and manufacturers should work together to addressing “teething problems” in the rollout.
“The reality is there is a shortage of vaccines…(But) we don’t doubt that manufacturers and producers are working 24-7 to bridge the gaps and we’re confident the delays we are seeing now are going to be made up by extra production in the future.”
As he spoke, Europe’s fight to secure COVID-19 vaccine supplies sharpened when Britain demanded that it receive all the shots it paid for after the EU asked AstraZeneca to divert supplies from the UK.
The EU, whose members are far behind Israel, the United Kingdom and the United States in dispensing vaccines, is scrambling to get supplies just as the West’s biggest drugmakers slow deliveries to the bloc due to production problems.
The city government of Manila is targeting the vaccination of about 18,000 individuals a day and said schools and churches are among 18 sites being eyed as vaccination sites.
“We are targeting a maximum goal of at least 18, 000 individuals per day on initial plan, so within 30 days, from Monday to Sunday, more or less 540,000 would be vaccinated,” Moreno said after inspecting a second mass simulation exercise for the vaccination, at the Isabelo De Los Reyes Elementary School in Tondo.
The first simulation exercise was held early this month at the Universidad de Manila.
About 1,000 individuals composed of barangay officials and youth leaders took part in the exercise.
Moreno said the public and private school teachers in the city, numbering about 10,000, will also be given priority in the vaccination program, aside from medical health workers, policemen. and senior citizens.
The Department of Health warned the public using of anti-inflammatory drug colchicine, which is used to treat gout, for COVID-19 patients.
Recent reports said colchicine is helping improve the condition of COVID-19 patients with mild symptoms.
Health Undersecretary Maria Rosario Vergeire said there is not enough evidence to show it can be used for COVID-19.
“We need to wait for the complete details, sufficient evidence before we are able to use it,” she said. — With Jocelyn Montemayor, Ashzel Hachero, and Reuters