The drugmaker Pfizer and BioNTech called their report “a great day for science and humanity.”
Pfizer and BioNTech reported a 90 per cent efficacy of their coronavirus vaccine. The Drugmaker were the first in the world to share data on the results of the final phase of vaccine research.
And while questions remain, such as what level of protection the vaccine gives, to whom and how much, scientists welcome the first convincing evidence of the vaccine’s effectiveness.
A Turning point in a pandemic
The use of the coronavirus vaccine developed by the German pharmaceutical company BioNTech, which deals with immunotherapy drugs, in collaboration with the American corporation Pfizer, reduces the risk of COVID-19 by 90 per cent.
The drugmaker state that no serious side effects of BNT162b have been identified in the phase III trials involving 43,538 patients in various countries. Half of them received antigen and the other half received a placebo.
The data were collected by the independent Data Monitoring Committee (DMC), which reported “no major safety concerns” and recommended further research.
The vast majority of the “side effects” were mild: after the second injection, 17 per cent of participants in the younger age group and 8 per cent of the older ones had a fever up to 38-38.9 ° C.
This is the first, albeit preliminary, direct evidence that any vaccine is really effective against coronavirus – before that, it was only about safety and immunogenicity.
These are the first, albeit preliminary, direct evidence that a vaccine is actually effective against coronavirus – before that it was only about safety and immunogenicity.
“We are well on the way to ensuring that people around the world desperately need a breakthrough and help end this global health crisis,” said Dr Albert Bourla, chairman of Pfizer.
And co-founder of BioNTech, Professor Ugur Sahin, called the vaccine results “a turning point.”
“But the bottom line is, as a vaccine it’s more than 90% effective, which is extraordinary,” top U.S. infectious diseases expert Dr. Anthony Fauci told CNN.
In parallel with the vaccine efficacy research, Pfizer continues to compile vaccine safety data. The final results are planned to be published in a peer-reviewed journal.
Based on projections, BioNTech expects to produce up to 50 million doses of the vaccine this year and 1.3 billion doses in 2021. The EU is already preparing a contract to order 300 million doses of the drug.
According to Reuters, the vaccine will not go on sale anytime soon. In addition to the fact that it must obtain permission from the regulatory authorities, accessibility to a wide range of people will be limited due to special storage conditions.
Pfizer and BioNTech may submit safety data for their vaccine by the end of November. After that, it is necessary to obtain permission before the first deliveries. It is assumed that the first to receive the vaccine will be health workers and at-risk groups.
At the same time, the complex requirements for the vaccine and its ultra-cold storage can become a barrier to even the most modern hospitals in the United States, not to mention its availability in less affluent countries. This vaccine must be stored at -70 ° C.
Storage will become the main problem of vaccination, since not all clinics, even in mega-cities, have capacities that could maintain such an ultra-low temperature.
The Pfizer / BioNTech vaccine is an mRNA-based drug with modified nucleosides (nucleotides bound to a monosaccharide – the main building blocks of life for the two main biomolecules).
This mRNA encodes a full-length mutant S-protein in its prefusion form.
What about other vaccines?
Pfizer is now in its third phase of clinical trials. In the third phase of clinical trials, the immediate efficacy of the vaccine is evaluated.
Before that, they look at the safety of the vaccine and the indirect signs of effectiveness: the credits of antibodies, their ability to neutralize the virus, the T-cell immune response.
In phase three, scientists directly calculate how many people became ill after vaccination and compare this number with those in the control group vaccinated with placebo.
Pfizer / BioNTech, however, is not the only one: soon the first results can be expected from AstraZeneca, Moderna, Johnson & Johnson, the Gamaleya Institute and several Chinese companies.
AstraZeneca vaccine, which is being developed jointly with the University of Oxford, was previously the world’s hope. They started talking about it in April this year. Then the New York Times wrote that British developers were ahead of the rest of the competition and “was the recognized leader of the race.”
However, in September, clinical trials were frozen due to a serious illness of one of the volunteers.
In early November, Andrew Pollard, the head of the development team for this vaccine, said that the research results would be presented before the end of the year.
When asked if it was possible to start using the vaccine before Christmas, Pollard said the chances are less. According to him, by the end of the year, scientists are going to establish whether the developed vaccine is effective, after which the data will be carefully studied by regulatory authorities, and then a decision on registration will be made.