Pediatric News

Big Leap: U.K and Bahrain approve use of Pfizer and BioNTech COVID- 19 mRNA vaccine

Dr. Reepa Agrawal
More..

Big Leap: U.K and Bahrain approve use of Pfizer and BioNTech COVID- 19 mRNA vaccine

09 Dec, 2020

In the war against COVID-19 science has now finally provided a vaccine which could be like a protective shield against the SARS-Cov-2 virus infection. The Pfizer and BioNtech mRNA vaccine against COVID -19 (BNT162b2) is now approved by U.K Medicines and Healthcare products Regulatory Agency (MHRA) and Bahrain National Health Regulatory Authority for emergency use in respective countries.

The U.K became the first country in the world to approve it, within 2 days of which the same vaccine got approval in Bahrain. A phase 3 clinical trial by Pfizer and BioNTech of this mRNA vaccine showed an efficacy of 95% and found the vaccine to be safe. This vaccine approval request is at present pending with U.S FDA and E.U European Medicine Agency. Joint Committee on Vaccinations and Immunisations (JCVI) in the U.K. has made a priority list and elderly in care homes as well as care workers are on the top of the list to receive this vaccine once rolled out. The U.K. has booked 40 million doses of the vaccine. The cost per dose is approximately 20$ per dose.

This will be the first-ever mRNA vaccine however there has been a lot of research going on for a long time on the use of RNA-based vaccines. Such vaccines are relatively inexpensive to be produced rapidly on a mass scale. This contains mRNA which is produced in a lab and once injected in the host will translate to produce S protein (spike protein) which is immunogenic. According to scientists, this mRNA does not enter the host cell nucleus hence will not affect host cell DNA. It will be administered in 2-dose regimen 3 weeks apart and maintaining a strict cold chain is crucial. It will be shipped and stored at -70oC and once thawed can be stored between 2-8oC for 5 days. At present, the reported side effects during the trial are not serious and consist of headache, fatigue, pain at the injection site, fever, myalgia. It is important to note that during the trial till now there were 10 severe COVID 19 cases, 1 was in the vaccinated group and 9 were in the placebo group. Some questions are unanswered mainly regarding how long will the immunity against SARS-Cov2 last after the 2 doses of vaccine, what if antibodies wane, does immunity last, and will booster doses be added. Interestingly when antibodies wane off if the vaccine can stimulate memory B cells then the immunity may last much longer however no published data is answering these critical questions. Phase 3 of the trial started on July 27 2020 and it will be collecting safety and efficacy data for 2 more years.

Other vaccines notably by Moderna (mRNA vaccine) and the one being developed by AstraZeneca in collaboration with Oxford University and Serum Institute of India (viral vector vaccine) are also expected to be hopefully of use in the fight against the COVID-19 pandemic.

References:

• www.pfizer.com

• www.cdc.gov

• www.gov.uk

• Maruggi G, Zhang C, Li J, Ulmer JB, Yu D. mRNA as a Transformative Technology for Vaccine Development to Control Infectious Diseases. Mol Ther. 2019;27(4):757-772. doi:10.1016/j.ymthe.2019.01.020

• www.clinicaltrials.gov

Big Leap: U.K and Bahrain approve use of Pfizer and BioNTech COVID- 19 mRNA vaccine

Home

Partner Sites

Big Leap: U.K and Bahrain approve use of Pfizer and BioNTech COVID- 19 mRNA vaccine

Author Information

Home

Partner Sites