Bharat BioTech’s COVID-19 vaccine Covaxin has been approved for export to the Philippines, Food and Drug Administration director general Eric Domingo said Friday.
According to Domingo, this developed after the FDA revised the emergency use authorization issued to Covaxin since its importer, IP Biotech Inc., already submitted its Good Manufacturing Practice Certificate, Risk Management Plan, and updated Chemistry, Manufacturing, and Controls.
“They initially failed to submit required certificates, although they already passed the inspection for good manufacturing practice. Now, they can import Covaxin here and we can already use it here,” Domingo said.
Indian Ambassador to the Philippines Shambhu Kumaran earlier said an EUA was issued to Covaxin in April.
Based on the FDA evaluation, Covaxin is given in two doses to those aged 18 years old and above, with the second dose given 28 days after the first dose.
“Based on the totality of evidence available to date, including data from adequate and well- known controlled trials, it is reasonable to believe that the Bharat Biotech COVID-19 Vaccine may be effective to prevent, diagnose, or treat COVID-19,” the FDA stated in its June 21 letter.
Covaxin’s storage requires 2 to 8 degrees Celsius, and the doses should be used within six hours once opened.
Meanwhile, a vaccine with an overall efficacy rate of 90.4 percent and a 93.2 percent efficacy against variants of interest and concern, developed by US biotechnology company Novavax, is expected to arrive in the country in the third quarter of the year.
The vaccine’s trade name in the Philippines is Covovax.
This was announced by Faberco Life Sciences Inc., the local pharmaceutical firm that has secured the distribution rights to the vaccine in the Philippines.
“Manufacturing for Covovax has started at Serum Institute of India, which is the largest manufacturer of vaccines in the world. The target delivery to the Philippines of the first batch of Covovax vaccines is within the 3rd quarter of this year.” said Dr. Luningning Villa, medical director of Faberco.
Serum Institute of India has an exclusive agreement to manufacture Covovax for low- and middle-income countries such as the Philippines, using the latest COVID-19 vaccine technology developed by Novavax.
The company is testing a third dose as a six-month booster, and early data suggests it produces a strong immune response.
The US/Mexico study enrolled 29,960 participants across 119 sites to evaluate the efficacy, safety, and immunogenicity, with an emphasis on recruiting a representative population of communities and demographic groups most impacted by the disease.
The Phase 3 trials conducted earlier in the U.K. yielded a higher overall efficacy rate of 96.4 percent for the original COVID-19 strain.
It also showed high efficacy against predominantly circulating variants and complete protection against moderate and severe disease.
“We are very pleased with the results of the trials and look forward to providing Filipinos a new high-quality vaccine soon,” Dr. Villa said.
In a related development, another shipment of COVID-19 vaccines is expected to arrive Sunday, according to the Bureau of Customs – Ninoy Aquino International Airport.
This time, the shipment contains the first batch of US made Moderna vaccines composed of at least 200,000 doses which is expected to land at the NAIA around 11 p.m. via Singapore Airlines.
Vaccine czar Secretary Carlito Galvez Jr. said the national government had secured 20 million doses of Moderna vaccines through a tripartite agreement with the private sector.
He added 13 million doses were procured by the state while the rest was bought by the private sector.
Meanwhile, labor group Trade Union Congress of the Philippines called on the government to also prioritize in the vaccination program all aircrew amid the reopening of the tourism sector and the economy.
The TUCP appealed to the Inter-Agency Task Force for the Management of Emerging Infectious Diseases to provide A1 priority vaccination of cabin crews, flight attendants, pilots and other aviation workers.
“Aircrew are all frontline workers, similarly situated as seafarers and overseas Filipino workers due for deployment, who contribute enormously to keeping our economy afloat under a dangerous health environment, and should therefore be given firstline priority by government for mass vaccination against the threat of COVID-19 infection, TUCP president Raymond Mendoza said.
“Air transport is a frontline activity underpinning both human mobility and global trade. Air transport relies on aircrew, who travel across borders at all times,which may result in the need to present proof of COVID-19 vaccination as a condition for entry in some countries,” he added.