The collaboration of a major U.S. pharmaceutical company i.e., Pfizer and a German biotechnology firm i.e., BioNTech seems to head out to be the top candidate in the Covid vaccine race as the UK is the first country in the world to approve this Covid-19 vaccine for emergency use in the country.
Who decided the vaccine approval?
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) said that the decision by the UK regulatory authority was made with advice from the Commission on Human Medicines along with MHRA scientists and clinicians who carried out a rigorous, scientific and detailed review starting in October 2020.
If you are wondering how was the assessment done so quickly, it was due to a regulatory process known as a ‘rolling review’ which can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible.
How will the shots roll out?
The vaccine doses of Pfizer-BioNTech candidate for Europe is being produced in BioNTech’s German manufacturing sites, as well as in Pfizer’s manufacturing site in Belgium. The doses will be made available across the U.K. starting next week after it gets 800,000 doses from Pfizer’s manufacturing centre in Belgium.
The UK’s vaccine committee will decide who will get the doses first which is most likely to be care home residents, frontline workers, the elderly and people who are clinically extremely vulnerable.
However, one thing to note is that final testing of the candidate is still not complete and the emergency use is still experimental. The safety and effectiveness will have to be monitored once the doses are rolled out and how people widely respond to it.
Pfizer had submitted the vaccine application to the US health regulator United States Food and Drug Administration (USFDA) last month and the decision is expected to come by this month.
What about other vaccine candidates?
Meanwhile, other vaccine candidates like Moderna and AstraZeneca have also claimed to show impressive effectiveness and are seeking clearance for emergency use of their respective candidate from the health authorities.
The Oxford-AstraZeneca vaccine candidate has already submitted its review application with the MHRA and the decision is yet to come. As far as India is concerned, the Serum Institute of India (SII) is in the process of seeking emergency use authorization from the DGCI for the AstraZeneca Covid-19 vaccine.
On the other hand, Dr. Reddy’s and the Russian Direct Investment Fund (RDIF) have started phase 2/3 clinical trials for COVID-19 vaccine Sputnik V in India after receiving necessary clearance from the Central Drugs Laboratory in Himachal Pradesh.
Zooming Out,
From talking about developing of vaccines to planning its distribution and now finally talking about the approval and rolling out of the vaccine doses, looks like the world is finally a step closer to getting the Covid-19 vaccine as the roller-coaster 2020 ends.
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