FDA Advisory Committee-recommended! The Pfizer-BioNTech COVID-19 vaccine

 Copyright © Françoise Herrmann

On December 10, 2020, the US Federal Drug Administration (FDA) Vaccine Advisory Committee recommended an Emergency Use Authorization (EUA) for the COVID-19 BNT162b2 vaccine, developed and manufactured by Pfizer-BioNTech, in Germany. Thus, the BNT162b2 vaccine has cleared a major hurdle to become the first, long-awaited, FDA-authorized vaccine in the US, designed for the prevention of COVID-19, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).  A virus that has infected, to date, close to 70 million people worldwide (1.5 million in the US), claiming more than 1.5 million lives worldwide (close to 300 thousand in the US) (WHO Dashboard; JohnHopkins CoV Resource Center). A virus, now raging a second time, that is also paralyzing world economies.

The FDA Vaccine Advisory Committee recommendation comes exactly one week after the United Kingdom authorized the same vaccine for a mass vaccination campaign, on December 3^rd; and one day after authorization in Canada, on December 9^th. The votes, recommending emergency vaccine use in the US, cast by 17 of the 23 expert scientists on the FDA Vaccine Advisory Committee, kickstarts the FDA authorization process. A process that escalates the Advisory Committee recommendation to the FDA Commissioner, Stephen Hall, who has to sign off on the authorization for emergency use, before US Marshal-escorted shipments of the vaccine, from Germany to every US State, can begin, and Operation Warp Speed kicks off. Vaccinations would then be administered approximately 96 hours, following FDA authorization (Smith & Rahhal, Dec 10, 2020).

The Pfizer-BioNtech COVID-19 vaccine is a nucleoside-modified messenger ribonucleic acid (modRNA) type vaccine (FDA - Pfizer-BioNTech). This means that to produce the vaccine an mRNA strand was modified to code for the coronavirus spike glyco-protein (S). The spike viral glycoprotein S is the red tentacle-like glycoprotein, represented on the surface the SARS coronavirus-2, that gives the virus its unique profile (see image). Once engineered, and covered with protective lipid nanoparticle (NP) carriers, the modRNA strands are then injected into the human body, where the message to produce (harmless) glyco-protein spikes is delivered within human cells. The production of spike glyco-proteins is then believed to trigger an immune response, where the human body creates antibodies against the (harmless) intruding glyco-protein spikes. Antibodies, which will then circulate, ready to mount an attack, in case a person is actually infected with the SARS coronavirus 2, since the antibodies will be able to recognize the glyco-protein spikes, attached to the surface of the (dangerous ) virus, for the purposes of binding to the virus and preventing its replication (extrapolated from Weintraub & Padilla, June 21 2020).

The Pfizer-BioNTech vaccine is supplied in a multi-dose (5-dose) vial stored at extremely low temperature, between -80°C to -60°C (- 112°F to -76°F)].  Once thawed and diluted into five, 0.3 mL, doses, the vaccine has to be injected within 6 hours. Thus, the vaccine’s temperature storage requirements make it difficult to transport and deliver, not to mention almost impossible to use in Third World countries where facilities for such extremely cold storage might not be readily available. The vaccine is otherwise administered as a series of two, 30 µg (0.3 mL) doses, via intramuscular injection, 21 days apart (FDA - Pfizer-BioNTech). Another FDA Advisory Committee recommended that vaccinations in the US begin with health care workers, the elderly in nursing homes, and the staff taking care of them.  

Different sorts of bio-engineering technologies are invoked in the Pfizer-BioNTech vaccine. The Lipid nanoparticle (NP) carrier technology for the modRNA strands is, for example, recited in the following US utility patent applications and patents, granted to BioNtech.

• US2020/0155671 – Particles comprising a shell with RNA.
• US2018/0263907 - Lipid Particle Formulations for Delivery of RNA and Water-Soluble Therapeutically Effective Compounds to a Target Cell.
• US2017/0273907 – Stable formulations of lipids and liposomes.
• US10576146 – Particles comprising a shell with RNA.
• US10485884 – RNA formulation for immunotherapy.
• US9950065 – Particle comprising a shell with RNA.

References

FDA Briefing Document  - Pfizer-BioNTech COVID-19 Vaccine (Dec. 10, 2020).   https://www.fda.gov/media/144245/download

John Hopkins CoV Resource Center.     https://coronavirus.jhu.edu/map.html

Smith, J, and N. RAhhal (Dec 10, 2020) FDA panel votes to give emergency approval to Pfizer's coronavirus vaccine - but the shot won't ship to Americans until the agency signs off and a final verdict could take DAYS. DailyMail.com.      https://www.dailymail.co.uk/news/article-9039119/  

Weintraub, K.  and R. Padilla (June 21, 2020) Vaccines are not all created equal: A variety of ways to stop the virus that causes COVID-19.      https://www.usatoday.com/in-depth/news/health/2020/06/21/different-technologies-developing-vaccine-against-covid-19/5318458002/

WHO  Coronavirus Disease (COVID 19) Dashboard.   https://covid19.who.int/?gclid=CjwKCAiAq8f-BRBtEiwAGr3DgTBY2t_njp3yW4kHF--UtD3vhq5bCvzrTIAjtppWIC9P-J5FRvmtQhoCI-EQAvD_BwE