The race to unveil an effective COVID-19 vaccine continues to pick momentum as leading companies in the UK, Europe, and the US eyed to produce an effective vaccination by the end of 2020. Also, the competing companies seem to rival against each other instead of what most would expect them to work together to achieve a 100% safe and effective vaccine. This was portrayed when the UK, through its Medicines and Healthcare Products Regulatory Agency (MHRA), approved the first vaccine against COVID-19 and attracted criticism instead of a round of applause from all over the world.
Hours after the UK gave temporary authorization to the Pfizer vaccine on December 2, 2020, the European Medicines Agency (EMA) gave out a stiff statement citing that more work than MHRA had done was needed. In response, MHRA’s chief executive, June Raine, pointed out that the agency had “simply taken advantage of a provision that any country in Europe could use to fast-track approval in a pandemic.”
On the other hand, the UK COVID-19 vaccine approval suffered a more stinging blow from the US side through the prominent head of the National Institute of Allergies and Infectious Diseases, Prof Anthony Fauci. Criticizing the UK move to approve the vaccine, Prof Fauci reckoned that the US regulator, the Food and Drug Administration (FDA), was proceeding in the right way while the UK “did not do it carefully,” which he later comprehensively expressed his regrets citing he had “great faith in both the scientific community and the regulatory community in the UK.”
What’s taking Europe and the US so long?
You might be wondering if Europe or the US are doing it differently; that’s why they’re taking so long in approving their vaccines. For Europe, their process is not so different from the one adopted by the MHRA. EMA adopted many of the Medicines Control Agency’s existing procedures, which became the MHRA when it was set up in the 1990s in Canary Wharf, London. EMA’s take on the UK vaccine was that the UK had opted for temporary emergency approval of specific vaccine batches. That was the difference, according to EMA, from the “conditional marketing authorization” it hoped to permit in a few weeks, which would signal nay European country to use the vaccine.
On the US side, there are reportedly significant variances. Minimal evidence shows that the US regulatory agency (FDA) is generally slower than Europe. All of them take the main role of a regulator seriously—safety— but FDA seems to go an extra mile.
Moreover, the FDA, being the oldest and most influential regulator globally, has a varied history from the MHRA. FDA was established to safeguard consumers both in terms of effectiveness and safety. On the other hand, Europe’s drug regulations were founded to satisfy the need to align commercial regulation; the reason critics cite them as being pro-business. If you remember the Thalidomide scandal that struck in the UK and many other parts of the world causing birth defects, except the US after the FDA turned it down, then you understand what this means.
Why the FDA approval process is taking longer.
Slow but sure perfectly describes the FDA’s vaccine approval process. The FDA takes all the raw data from the lab, animal and human trials, and does its own statistical analysis. The agency then convenes advisory bodies consisting of leading experts and scientists to address scientific issues. As the FDA’s commissioner stated, the FDA is “one of the few regulatory agencies in the world that actually looks at the raw data.”
On the other hand, FHA states that safety is vital and that it has left out no corners, also considering it has an impeccable global reputation to uphold.
Nevertheless, let’s be patient and hope that the agencies will unveil vaccines that will help eliminate the coronavirus from the face of the earth. That will be a massive win for us, the generations to come, and for humanity at large.
Work cited.
