The Covid-19 vaccine from AstraZeneca can now be used locally on a limited scale after the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the said product.
On Thursday, FDA said the benefit of using the vaccine developed by Oxford University and manufactured by British pharmaceutical company, AstraZeneca, outweighs its known and potential risks, which currently are similar to that when taking a flu vaccine, such as getting a fever and headache.
“The adverse events reported were transient and mostly mild to moderate, similar to common vaccine reactions. No specific safety concerns were identified and of course, it must be noted, this reflects limited follow up,” Food and Drug Administration (FDA) director general Eric Domingo said in an interview with PTV.
In the EUA, FDA said the vaccine regimen for the COVID-19 Vaccine AstraZeneca consists of two equal standard doses of 0.5 milliliter each given four to 12 weeks apart.
Domingo explained a person, who get a least a single dose of the vaccine will get a 70 percent chance of preventing possible Covid-19 infection, as well as almost 100 percent of preventing severe symptoms in case they are reinfected.
The efficacy rate of the vaccine could increase with its second dose.
Use restriction
The vaccine, could only be administered to those, who are are at least 18 years old, according to Domingo.
The COVID-19 Vaccine AstraZeneca can be used by the Department of Health (DOH), National Task Force Against Covid-19 (NTF) or their designees including hospitals, national government agencies, local government units and other members of the private sector.
Domingo stressed the EUA is not a marketing authorization or a Certificate of Product Registration so it could not be commercially sold in the local market for now.
The government is finalizing the its negotiation with AstraZeneca to secure 17 million doses of its Covid-19 vaccine.
Aside from AstraZeneca, FDA has only issued an EUA to the Covid-19 vaccine of Pfizer-BioNTech.
Currently, Sinovac, Gamaleya, and Bharat Biotech are also applying for an EUA from the FDA for their respective Covid-19 vaccine.
Domingo said it may take some time before the EUA of the said vaccines are approved since they have yet to pass the “stringent regulatory authorities from the United States and the United Kingdom.