As the COVID-19 pandemic continues, public interest in regulatory affairs and medical developments has never been greater.
With mass vaccination programmes now in operation throughout the world, the thirst for information and facts has created great, and sometimes heated, debate, mainly on social media, about the safety and efficacy of these initiatives and the formulas being used as well as the actual disease itself.
The rise in misinformation and conjecture in some parts of the world is concerning. COVID denial and opposition to any form of vaccination have been displayed at protests and there is a growing need to ensure the public is fully informed and dealing with facts when making any decisions relating to COVID-19.
The International Coalition of Medicines Regulatory Authorities (ICMRA) recently reiterated this point and highlighted the vital role healthcare professionals and public health authorities can play in ensuring the myths and rumours surrounding vaccination are dispelled, something the European Medicines Agency was quick to agree with.
In a bid to alleviate public fears and concerns, the ICMRA has published a report detailing the key concerns surrounding the vaccines and explains the arrangements put in place both nationally and globally for ongoing safety monitoring of COVID-19 vaccines once they are on the market.
The full report can be found here with some of the most asked questions detailed below:
Q: How have the vaccines been developed so quickly? Does this mean that their safety and efficacy has been compromised?
A: The speed of development of COVID-19 vaccines has been unprecedented for several reasons:
The massive financial investment by governments – in the tens of billions of dollars or more, in vaccine development and the redirection of much of the global research and commercial vaccine developing and manufacturing infrastructure. This also enabled companies to take the commercial risk of manufacturing some vaccine stocks ahead of regulatory approvals as governments underwrote the risks of costs of failure.
New technologies adapted from the development of other vaccines – mRNA vaccines were developed very rapidly after the sequence of the COVID-19 virus was determined, and production was scaled up very quickly. The adenovirus technology used in another type of vaccine was first tested with SARS and MERS over the last 20 years, and so was able to be adapted quickly to COVID-19, which has several similarities to these viruses.
Clinical trial successes – because of the high concerns about COVID-19, it has been possible to rapidly recruit large numbers of volunteers into clinical trials and, with unfortunately high rates of infection in several countries, complete trials using 10,000–50,000 subjects in a short period of time.
Very close collaboration – between regulators, industry and clinical researchers enabled clear indications of regulatory requirements and early access to results.
Intensive and insightful research –researchers predicted that the “spike protein” on the virus would be a good target for vaccine development, and almost all vaccines have used this part of the viral sequence. So far, the spike protein has produced a strong immune response in those vaccinated, and for those vaccines that have reported clinical results, high efficacy of protection from COVID-19 disease.
Q: Will mRNA vaccines affect the DNA of vaccinated patients?
A: No. The mRNA in the vaccine cannot incorporate itself into the genes of vaccinated patients and generally breaks down in the weeks after vaccination.
Q: How long will COVID-19 vaccination provide protection for immunised people?
A: The experience with other vaccines shows variable durations of protection. For example, seasonal influenza requires annual vaccinations, because the virus mutates. Other vaccines, such as those for rubella or measles provide multi-year or even lifelong protection from disease. While there appears to be some mutation of the SARS-2-coronavirus, results to date indicate that mutations are limited, not necessarily affecting the target of the vaccines.
Q: What if many people start getting a reaction from a particular COVID-19 vaccine?
A: Short-term reactions, such as soreness at the injection site, fatigue or headache are common following vaccination. These reactions usually pass in a day or two.
If serious adverse events (SAEs) emerge for a particular vaccine, then regulators will take action, working collaboratively, and on a global basis, and will liaise with public health authorities.
Q: What are “faster access pathways”? How are regulators speeding up the time it takes to authorise a COVID-19 vaccine?
A: Many regulators globally have implemented faster access pathways for COVID-19 vaccines.
Some countries have Emergency Use Authorisation pathways which assess the limited available data at the time of authorisation. Exercising these provisions is a matter for those countries, considering the risks versus benefits in the context of the prevailing domestic pandemic situation.
Other countries have implemented accelerated/priority, conditional or provisional approval schemes. Under normal circumstances, regulatory assessment begins once all information to support registration is available. For COVID-19 vaccines, many regulators have agreed to accept data on a rolling basis to enable early evaluation of data as it becomes available.
The implementation of various accelerated regulatory pathways in combination with international collaboration between regulators and proactive work with sponsors is expected to significantly expedite the evaluation of COVID-19 vaccines without compromising on strict standards of safety, quality and efficacy.
Q: Did our country approve this COVID-19 vaccine, or are we relying on another country’s approval?
•Countries are carrying out independent regulatory evaluations on the submitted data for each vaccine. However, regulators are communicating closely on safety, efficacy and quality data and discussing technical issues as they may arise. This approach provides the best of both worlds, independent decision making coupled with the expertise of scientists working globally together.
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