Korea’s Ministry of Food and Drug Safety said Monday that it has started the 40-day expedited review process for the Pfizer-BioNTech COVID-19 vaccine.
Pfizer applied for the emergency use approval of its vaccine Monday, the Drug Ministry said. If it passes the fast-track review, the vaccine could be available in Korea no later than mid-March. The mRNA vaccine will be produced in Belgium, according to Pfizer.
It is the second COVID-19 vaccine seeking local use permit. AstraZeneca on Jan. 4 applied for emergency use of its jabs in Korea.
According to the Drug Ministry, Pfizer has applied for use of its vaccines on those older than 16, with two injections three weeks apart and storage requirement between minus 60 to 90 degrees Celsius for a maximum of six months.
It remains to be answered how the Korean government plans to provide the logistics of the vaccine.
Although the Pfizer-BioNTech shot is being inoculated elsewhere around the globe, the local authorities must review the drug’s data prior to releasing them to its people, for safety assurance.
The drug has gained provisional approvals from 28 countries so far. The US’ Food and Drug Administration was the first to approve it for emergency use in December 2020.
The European Union gave its nod after seeing a 95 percent efficacy rate. The WHO puts the bar at 50 percent efficacy rate for aspiring COVID-19 vaccines.
Reported side effects are rare in terms of the ratio of people given the shots. However, Norway’s case of 23 elderly deaths has raised concerns among global authorities tracking other nations’ progress with vaccination.
Norway is investigating the exact cause of the deaths, but has said there is no evidence of a direct link to the vaccine.
Pfizer co-developed the world’s first vaccine against COVID-19 with Germany’s BioNTech. The vaccine’s working mechanism operates by injecting the genetic information of SARS CoV-2 virus’ antigens to the human body, after which the innate human immune system creates more antigen proteins and provokes immune response against COVID-19.
MRNA vaccines have shorter manufacturing period which enables mass-production within a short time span.
The mRNA genetic chain can easily disintegrate in warm temperature, however, and requires storage in ultra-cold chain to maintain efficacy.
Pfizer is currently conduction the last stage clinical trial of its vaccine in six countries -- the US, Germany, Brazil, Argentina, South Africa and Turkey.
It is testing the vaccine on those older than 12, including seniors past the age of 65.
The states that have given emergency approval for the Pfizer-BioNTech vaccine are: World Health Organization, the UK, the US, Canada, Bahrain, Israel, Qatar, Mexico, Oman, Kuwait, Singapore, Lebanon, Costa Rica, United Arab Emirates, Ecuador, Chile, Panama, Jordan, Iraq, Colombia, Tunisia, the Philippines and Australia.
Those who have provisionally agreed to the vaccine’s use are: the European Union, Switzerland, Saudi Arabia, Argentina, Serbia and Malaysia.
In both groups of nations, Pfizer must report 24-month follow-up data of all those inoculated with the vaccine.
This safety evaluation will wrap up in January 2023.
By Lim Jeong-yeo (email@example.com