The Vaccine is an mRNA Vaccine, a novel method that introduces viral RNA into the body via a viral coat.
COVID Vaccine, the Pfizer update
On Monday Pfizer announced to the world the vaccine, once it has been developing with Germany's BioNTech, was found to be more than 90?fective. If this is substantiated, it may be possible for countries to receive the vaccine before the end of the year.
The Vaccine is an mRNA Vaccine, a novel method that introduces viral RNA into the body via a viral coat. The vaccine is incorporated into the person's cell, where the viral RNA is read and viral proteins are produced, including the coronavirus coat proteins. As the body reads and recognizes these proteins, it produces antibodies against these viral proteins and activates immune T cells against the virus.
The Pfizer results are based of a phase 3 clinical trial with 43, 538 participants with a diverse background. In this trial, the participants were split between those receiving a vaccine, and those who received a placebo with no effect. The vaccine is administered in two parts, with a 90?ficacy obtained 7 days after the second dose. This would mean a person is vaccinated just 28 days after the initial vaccination.
The FDA usually looks for a minimum 50?ficacy in vaccination when approving new vaccines. It may surprise you that the annual flu jab is also estimated to be 50?fective. The data from Pfizer was verified by an external, independent Data Monitoring Committee. It used data from 94 patients enrolled in the trial and subsequently developed COVID. It is from this groupset that 90% of efficacy is obtained. This is not the final data analysis, and further publications are expected in late November, with a potential FDA Emergency Use Authorisation approval if the data continues to show promise.
If approved, Pfizer has the ability to make 50 million shots before the end of the year, and 1.3 billion by the end of 2021. Many countries are clamoring for their fair share of these limited resources; the US has already negotiated 200m shots, UK 50m, and Germany (one of the major financers for the Pfizer vaccine) over 300m for European Countries.
We should emphasize that rapid vaccine development on this scale at this speed was unheard of prior to COVID. Usually, the animal studies for vaccines can take 1-2 years. In that time Pfizer and others have managed phase 1-3 clinical trials in humans, something that usually takes upwards of 10 years.
There are many unanswered questions that remain from this information.
- How safe is the vaccine? Whilst safety information was not published, overall the vaccine appears to have minimal side effects. This is particularly difficult to state however since mRNA vaccines have never been used in people before.
- Does the vaccine prevent transmission? In theory, yes. If you are immunized the replication of the virus should be limited significantly, so the number of viruses in each cough will be much lower. However, we do not have data to prove that there is no transmission, but that is also because we have very little data overall.
- How long does the protection last? This is a very critical question. The 90?fectiveness rate was calculated just 7 days after the second shot, but it is likely this will change as data is collected over the long term. Some studies have suggested the antibody response fades within months following COVID infection. T Cell immunity on the other hand can stay for years, and it may be the effectiveness of creating a T cell immunity that dictates just how good this vaccine will be .