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M.most of us have experienced very dark days in 2020, trying to juggle work from home and school children, worrying about how to pay bills due to unemployment or, like me, trying to balance scientific research with work clinician in the fight against Covid-19. As a scientist, I firmly believe that scientific progress will provide the exit strategy from this pandemic. But I have often worried that we may not be able to get what is needed to prevent the spread of this virus, or that this would take a long time. I have never been happier to be proved wrong.
Britain is the first country to authorize the emergency use of a vaccine for Sars-CoV-2, the virus that causes Covid-19. So how did we get here so fast? The vaccine, developed by Pfizer and BioNTech, went through three phases of clinical trials to obtain the seal of approval of the Regulatory Agency for Medicines and Health Products, the UK body that guarantees the safety of medicines. In the third phase it was administered to more than 43,000 volunteers without any serious safety concerns. The data shows that the vaccine is 95% effective in preventing the development of Covid, with similar efficacy seen for age, sex, race and ethnicity, including the elderly.
The vaccine is a messenger RNA (mRNA) vaccine, which stands for “messenger ribonucleic acid”. Messenger RNA is essentially the blueprint that living cells use to transform gene sequences into the proteins that form their basic structures. Once injected, the mRNA in the vaccine is translated into a viral protein, which our immune system detects. The body generates an immune response in reaction to these viral proteins, which alone cannot cause disease, and this provides protection against the development of Covid-19.
In the field of vaccine research, this type of technology is completely new. Some scientists were skeptical that mRNA vaccines could provide the key to controlling this pandemic. But mRNA vaccines are surprisingly simple – they’re just a clever way to get a viral protein to generate an immune response, and after a few days the mRNA is broken down by the body, leaving only immunity to Covid behind.
To generate a good immune response, two doses of the vaccine will be given 21 days apart, with recipients protected for approximately one week after their second dose. To avoid unnecessary delays, the MHRA, with advice from the Commission for Medicinal Products for Human Use, the government’s independent scientific advisory body, has undertaken a rigorous “ongoing review” of vaccine data as it becomes available from ongoing studies. This proved that the vaccine was safe and was approved for use in the UK population starting next week.
The European Commission had recommended member states to wait for approval from the European Medicines Agency (EMA) before authorizing the vaccine, which is expected to arrive later in December. But despite claims by some ministers that Brexit has played a role in the UK’s ability to quickly approve the vaccine, this is not true: under EU law, national agencies in Europe are allowed to use screening procedures. that allow them to distribute a vaccine for temporary use nationwide. This was confirmed in a recent statement by the MHRA, considered the world leader in the regulation of medicines and vaccines.
The UK has already bought 40 million doses of the vaccine, with 800,000 expected to be distributed to some of our society’s most vulnerable people through a network of over 50 hospitals. The NHS and government departments have been working on the logistics of the program for some time. The first to receive the vaccine are the people most at risk of mortality and morbidity from Covid-19.
On December 2, the Joint Committee on Vaccination and Immunization (JCVI) released a revised vaccine priority list, based on the stage of the pandemic we are in. The JCVI has determined that the best strategy is for the elderly, particularly those in nursing homes and their carers, as well as frontline health and social workers – to be the top priority in the first phase of the vaccination program. Clinically extremely vulnerable adults, many of whom have spent indoor screens this year, have been moved higher on this list since the latest JCVI guide was published and will now be fourth in line to receive the vaccine.
Once the most vulnerable people have been vaccinated, the plan is to vaccinate those who are at greatest risk of exposure to Covid-19 due to their jobs, such as first responders, teachers, transport workers and the military. This phase of the program may change over time as more data and information becomes available on the impact of the pandemic and the vaccine.
The biggest challenge that remains is whether we are all willing to accept and trust the vaccine. Some fear that, for producing a vaccine so quickly, corners will have to be cut. But they really weren’t. Others were concerned that mRNA vaccines represented a new technology that could potentially alter the recipient’s DNA – again, this is not true. It is certainly true that vaccines have taken years to develop in the past, but most of that time was often not spent on undertaking clinical trials, but on raising funds for trials, negotiating contracts, and seeking regulatory approval. Historic vaccine trials have rarely taken place during a pandemic like this, as millions of people are exposed to infections every day and thousands of them are eager to participate in trials.
Despite the many horrors of 2020, there have been advantages: we have learned that if you divert an almost unlimited amount of funding and focus a large percentage of the world’s scientists, regulators and other critical infrastructures towards a single effort, it is You can get amazing results very fast things. For me, the question is not how we managed to get a Covid-19 vaccination in such a short period of time, but rather: why have we not yet managed to have the same impact on diseases such as tuberculosis, HIV and malaria, which has been killing millions of people for many years? And what could happen if we turn this urgent global effort towards the other challenges we face, such as environmental degradation or the insidious creep of antimicrobial resistance?
As much as we hate to admit it, humans are not entirely rational creatures. Many of our vaccine fears will not be allayed by the people who present us with scientific data. We make decisions like this largely based on our confidence in the advice we are given. I could inundate you with research data on why the vaccine is safe, but I suspect the most helpful thing doctors and scientists can do is urge people to say yes to the vaccine when it is offered. And when my turn comes, you’ll find me waiting impatiently in line for my vaccination.
• Dr Charlotte Summers is a professor of intensive care medicine at the University of Cambridge
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