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The United Kingdom has approved the Pfizer-BioNTech coronavirus vaccine, becoming the first country in the world to authorize its use in the population. The decision was announced at 8 a.m. on Wednesday and the administration of the first doses should start in a few days. The Pfizer / BioNTech vaccine took just ten months from development to first authorization, a record for solutions of this type that typically take years to market.
The UK Medicines Regulatory Agency (MHRA) has reviewed the analyzes and data provided by the two companies and collected during their clinical trials with some 44,000 volunteers that began last summer. In the last phase (of 3) of the trial, the vaccine was found to be 95 percent effective, a figure higher than expected by many experts and observers. Subsequently, the UK government implemented the MHRA authorization recommendation. British Health Minister Matt Hancock said in a tweet that “aid is on the way” and that “the national health system is ready to start vaccines early next week.”
Like several other countries, the UK also ordered the first doses of the vaccine from Pfizer-BioNTech prior to approval, so that they would be available immediately after authorization. In total, the doses ordered so far are 40 million, enough to vaccinate 20 million people: the vaccine must be administered with two injections one month apart; a first batch of 10 million doses should be available within a few days.
The first to receive the vaccine in the UK will be members of healthcare workers, social services, the elderly and other risk groups. Subsequently, the government plans to proceed with the administration of the largest possible number of people over 50 and younger people with other health problems. This second phase is expected to begin in early 2021, as more doses become available.
The first vaccine approved in the UK is based on messenger RNA (mRNA), the molecule that encodes and carries the instructions contained in DNA to make proteins. Vaccines based on this system use synthetic forms of mRNA, manufactured in the laboratory, that contain instructions for producing certain specific coronavirus proteins. In this way, the immune system learns to recognize and fight them, but without the risks that it would run in the case of a real coronavirus infection. The immune system can use the knowledge gained to counter these proteins to counter any actual infection.
The mRNA-based technique allows doses to be produced more quickly and simplifies some steps than traditional methods, but it is fairly recent and so far no mRNA-based vaccine has been commercialized or used on a large scale. Therefore, there are still some doubts about the potential and reliability of the system, although the news circulating in recent weeks about the experimental vaccines that use it are quite encouraging.
Pfizer-BioNTech are not the only ones to have developed an mRNA-based vaccine. For example, even the American biotech company Moderna did, which reported that it had found its vaccine to be 94.1 percent effective. The estimate is based on an analysis of data collected during phase 3 clinical trials. Moderna also started emergency clearance requests this week.
Unlike other vaccines, those from Pfizer-BioNTech must be stored at around -70 ° C, and this could pose a problem for distribution. Securing the cold chain will be one of the main challenges for the logistics of the new vaccine, although Pfizer has announced that it has developed containers with insulating material and dry ice, which should guarantee the maintenance of -70 ° C for several days.
Moderna’s vaccine must be kept at low temperatures, but the company recently reported that its solution is kept at -20 ° C and that, once thawed, it remains stable for thirty days if stored between 2 and 8 ° C. ° C. These temperatures of the refrigerator, and not of very powerful freezers, should pose less difficulties for the transport and storage of the vaccine in pharmacies and hospitals, already equipped with refrigerators to store other types of vaccines.
It is good to remember that to date we do not know how long the protection offered by these vaccines lasts, or how effective it really is outside of clinical trials. Vaccines are often less effective in the community than trials. It’s also unclear how long immunization lasts, because the Pfizer-BioNTech and Moderna vaccines have been around for too short a time to be able to accurately estimate them.
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