The British government on Friday proposed measures to give emergency approval to a safe and effective COVID-19 vaccine and train a large number of people in administering it in order to enable a fast-paced mass rollout.
If a vaccine is developed before 2021, the proposals will bolster existing powers that allow the Medicines and Healthcare products Regulatory Agency (MHRA) to consider approving its use, before a full product license is granted. However, the government stressed that COVID-19 vaccines will only be given to UK patients if proven to be safe and effective.
Improving Access to Vaccine
Professor Jonathan Van-Tam, Deputy Chief Medical Officer for England, said in a statement, "We are making progress in developing COVID-19 vaccines which we hope will be important in saving lives, protecting healthcare workers and returning to normal in future."
Van-Tam added, "The proposals consulted on today suggest ways to improve access and ensure as many people are protected from COVID-19 and flu as possible without sacrificing the absolute need to ensure that any vaccine used is both safe and effective." The UK went into a transition period with the European Union after the Brexit so that both sides can work out the details of their engagements.
Providing Temporary Authorization
The new measures proposed on Friday are necessary because, during the transition period, a new potential COVID-19 vaccine must be granted a license by the European Medicines Agency (EMA). The British government launched a consultation on Friday which will look to amend the Human Medicine Regulations 2012.
The measures could come into force by October, ahead of the winter season. The regulations will permit the MHRA to consider giving temporary authorization allowing patients to benefit while it undergoes the full licensing process, with reinforced conditions attached to ensure safety, quality and efficacy.
From 2021, the British regulator will have a national licensing system in place and will be responsible for granting licenses for potential COVID-19 vaccines and treatments once they meet high standards of safety and effectiveness.