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The Food and Drug Administration (FDA), the drug agency of the US government, granted emergency authorization for the coronavirus vaccine developed by the German biotechnology company BioNTech with the multinational pharmaceutical company Pfizer. It is the first major drug control body to authorize a vaccine to curb the pandemic in the West, following the UK’s authorization last week, and it will lead to the release of the first doses in the United States in the coming days.
Emergency
An emergency authorization allows a vaccine or drug to be distributed before all the necessary processes for actual approval have been completed, which will eventually be granted in the coming months by the FDA. The expedited procedure is planned by numerous drug control authorities and should be followed shortly also in the European Union, where analyzes of the data collected by Pfizer-BioNTech are underway.
Vaccines in the United States can affect all people over the age of 16, except pregnant women and those allergic to at least one of the substances in the vaccine. Allergic reactions have been reported in the UK in recent days, without any particular risk.
The first to receive the vaccine will be members of health workers and the elderly at risk, starting with those in nursing homes. Available doses will be limited for several weeks, but Pfizer has repeatedly argued that in the first months of 2021 it will be able to significantly increase production to meet high demand.
The United States had reserved 100 million doses of the vaccine before the summer, for $ 1.95 billion, when it was not yet clear whether it was safe and effective. Stockpiles of this type are quite common during vaccine development and serve to dispose of doses as soon as possible after authorization is granted.
95 percent
In clinical trials, the Pfizer-BioNTech vaccine was found to be 95 percent effective and did not produce any particular adverse effects. The last phase (of 3) of the trial involved almost 44,000 volunteers: one group received the actual vaccine, while another received a substance that did nothing (placebo). The researchers then waited for some volunteers in both groups to become ill with COVID-19 and then compared the collected data. 170 cases were identified over a period of approximately two months: 8 occurred in the vaccinated group, while the remaining 162 in the placebo group.
The most common adverse effects reported by volunteers were headache, injection site pain (sometimes with erythema), and fatigue. They occurred more frequently after the second dose, which should be given 21 days after the first, and resolved in most cases within 24 hours of administration.
The FDA approval came within hours of a recommendation from an advisory group, which had been commissioned by the same agency to analyze and discuss the data provided by Pfizer-BioNTech. After the meeting, the experts concluded that there was a basis for advising authorization of the vaccine. The same commission will meet on December 17 to analyze data provided by Moderna, another biotech company that has created a vaccine similar to the one just approved.
MRNA
Both Pfizer-BioNTech and Moderna vaccines are based on messenger RNA (mRNA), the molecule that encodes and carries the instructions contained in DNA to make proteins. They use synthetic forms of mRNA, made in the laboratory, that contain instructions for making some 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. For this reason, there are still some doubts about the potential and reliability of the system and some caution is required.
Doubts and warnings
To these doubts are added those debated for weeks on logistics. Unlike other vaccines, those from Pfizer-BioNTech should be stored at around -70 ° C, and this could be 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 developed containers with insulating material and dry ice, which should guarantee that -70 ° C is maintained for several days. Moderna’s vaccine should be stored at -20 ° C, but once thawed it remains stable for about a month at refrigerator temperature, making it easy to handle.
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 is also unclear how long immunization lasts, because the Pfizer-BioNTech and Moderna vaccines have been around for too short a time to be accurately estimated.
Less than a year
However, the FDA clearance marks a very important step in efforts to combat the pandemic. Less than a year has passed from its development in the laboratory to its authorization, an achievement unprecedented in the history of vaccines and which could follow other similar results as other manufacturers finish testing their solutions.
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