Traditionally, vaccines can take years to research and develop, so how is a vaccine approved for use so quickly?
Here, the PA news agency answers your questions about vaccine production and pandemic approval.
How did this come so quickly?
The time frame for developing and approving a Covid vaccine has been shortened due to the coronavirus crisis.
What is the usual process of developing a vaccine?
Traditionally, vaccine development takes several years and involves several processes, including design and development stages followed by clinical trials – which in and of themselves require approval before they even begin.
The tests take place in three consecutive phases – also called phases. The research will show whether a vaccine produces antibodies, but also protects people against disease. They will also identify any security issues.
Once the trials are completed, the information collected by investigators will be sent to regulators for review.
This is thoroughly analyzed by clinicians and scientists before it is approved for widespread use.
After that, after approval by regulators, people can start receiving the vaccine.
Is this different because of the pandemic?
The process looks slightly different in the trials for a Covid vaccine.
Although the early design and development phases are similar, the phases of clinical trials overlap – rather than sequentially.
But doesn’t that mean security is compromised?
Although some phases of the clinical trial process have run in parallel instead of one after the other, the safety checks are still the same as for any new medicine.
The Medicines and Healthcare products Regulatory Agency (MHRA) has adopted the phrase “safety is our password”.
Regulators have said they will “rigorously review” the data and evidence on the safety, quality and effectiveness of the vaccine.
And in most clinical trials, safety issues are usually identified in the first two to three months – a period that has already passed for most vaccine frontrunners.
How do regulators act so quickly?
Regulators have been conducting “ongoing reviews,” meaning that instead of going through piles of information at the end of the trials, they’ve been given access to the data while the scientists work.
An ongoing review of the vaccine data began several months ago.
This means that regulators can start looking at scientific data earlier than they traditionally would, which in turn means that the approval process can be speeded up.
Regulators sometimes have thousands of pages of information to go through with a fine-tooth comb – which understandably takes time.
Once all available data on the vaccine has been submitted, MHRA experts will carefully and scientifically review the safety, quality and effectiveness data – how it protects people from Covid-19 and the level of protection it provides.
Once this has been done, advice is sought from the government’s independent advisory body, the Medicines for Human Use Committee (CHM).
What does ‘approved for use’ mean?
To use a medicine in the UK, it must be licensed. This means it has passed all rigorous safety and efficacy controls and regulators have confidence in the findings of the clinical trials.
By reviewing the data as they become available, the MHRA can arrive at an earlier decision on whether or not the medicine or vaccine should be licensed without compromising the thoroughness of their assessment.
So what data will the regulator look at?
The information provided to the MHRA includes what the vaccine contains, how it works in the body, how well it works and what its side effects are, and who it is for.
This data should include the results of all animal studies and human clinical trials, manufacturing and quality controls, consistency in batch production, and final product specification testing.
The factories where the vaccines are made are also inspected before a license can be issued to ensure that the product supplied will be of the same consistently high standard.
What is the difference between the MHRA and the CHM?
The MHRA is the UK regulator of medicines and medical devices and ensures their safety, quality and effectiveness.
The CHM advises ministers on medicines. It consists of an independent group of advisers who are responsible for advising on the need and content of risk management plans for new drugs.
It also advises officials on the impact of emerging safety issues on the risk-benefit balance of licensed drugs.
The CHM also provides advice on “applications for both national and European marketing authorizations”.
Have pharmaceutical companies not yet started making vaccines?
Yes. Usually large-scale production and distribution does not begin until approval by the regulatory authorities. But in the case of Covid-19 vaccines, pharmaceutical companies started production even before final approval was given – risking being forced to cancel their work.