Euro Roundup: UK revs up for COVID vaccine approval.
The United Kingdom has introduced legislation on the temporary approval of unlicensed drugs and vaccines to support the rollout of COVID-19 products. Through the legislation, the UK is seeking to clarify the power to impose conditions on temporary authorizations and extend partial immunity from civil liability to pharmaceutical companies that outsource manufacturing.
Until the end of 2020, the European Medicines Agency (EMA) will handle the approval licensing of COVID-19 vaccines for use in the UK. However, the UK, like the remaining 27 member states, can temporarily authorize an unlicensed vaccine for domestic use pending the grant of an EMA license.
The government wants to make two changes to the temporary approval rules. Firstly, the government wants to clarify the power of the licensing authority to impose conditions in relation to temporary authorizations.
“This will provide certainty for both the licensing authority and those in the supply chain about the nature of the licensing authority’s power in this area. Imposing conditions is central to having an effective system of regulatory control, and that is in the interests of everyone in the supply change,” officials wrote in a memo to explain the legislation.
The second change relates to immunity from civil liability. Existing regulations grant partial immunity to certain companies that provide unlicensed products in response to public health threats upon the recommendation of the licensing authority. However, the immunity only applies to companies that produce their own products. Companies that outsource production remain fully liable, situation officials called “anomalous”. The new legislation extends protection to companies that outsource.
“If a COVID-19 vaccine is ready for deployment prior to 1 January 2021, these measures will bolster existing temporary authorisation powers that allow the MHRA to consider approving its use before a full product licence is granted, provided it is proven to be safe and effective during the extensive clinical trials. The measures are especially necessary for the context of the transition period,” Jo Churchill, the Parliamentary Under-Secretary for Health and Social Care, said.
The government is also changing the rules on the advertising of unlicensed vaccines. Under the new rules, unlicensed vaccines will be treated the same way as licensed products in terms of advertising to the public, enabling suppliers to run promotions aimed at healthcare professionals and the public with ministerial approval. The new rules are equivalent to those that already apply to non-COVID-19 vaccine campaigns.
Government ministers introduced the changes in the form of a statutory instrument, a form of UK legislation that enables the law to be revised without Parliament passing a new act. Under normal circumstances, statutory instruments are presented 21 days before they take effect. However, the government warned it may be necessary to exercise some of the new legislative powers within the 21-day period.
The government introduced the statutory instrument days before the UK Medicines and Healthcare products Regulatory Agency (MHRA) added a new section on post-Brexit trade with Northern Ireland to its guidance on the importation of medicines. In the new section, MHRA explained that unlicensed medicines can move between Northern Ireland and the other three countries that make up the UK without those involved sending additional notifications to the agency.
Medical Device Information System set for a full rollout in the UK in January
The UK is set to embark on a full rollout of its new Medical Device Information System (MDIS) early next year, boosting its efforts to improve oversight and contact patients linked to safety concerns.
Complications related to surgical mesh implants and perceived failings in the regulatory response to them have turned medical device safety into a political issue in the UK. MDIS is one part of the effort to improve the situation. In a policy paper published in June, the government framed MDIS to capture data from healthcare providers to improve monitoring of device performance and patient outcomes.
MDIS is currently in the pilot stage. Responding to a written question about plans to set up a device registry, Nadine Dorries, a minister in the Department of Health and Social Care, said NHS Digital hopes to move past the pilot stage and into a full rollout in January.
Dorries said MDIS will “enable patients to be identified and contacted where safety concerns are identified.” Other countries are also working on systems that enable the tracking of medical devices using unique identifiers. In the June policy paper, the UK government said it wants a “more comprehensive” system that looks at clinical outcomes in addition to device usage and traceability.
Swissmedic starts rolling review of Pfizer/BioNTech COVID vaccine
The Swiss Agency for Therapeutic Products (Swissmedic) has begun a rolling review of the COVID-19 vaccine being developed by Pfizer and BioNTech. Swissmedic, like other regulators including EMA, now has two COVID-19 vaccines under review.
Pfizer and BioNTech could soon become some of the first companies to share Phase 3 data on a COVID-19 vaccine. Ahead of the anticipated readout, the partners have begun filing for approval in regions that support rolling submissions. Swissmedic recently joined the list of regulators that has received the first part of a filing for approval of the vaccine, codenamed BNT162b2.
The Swiss agency said it is assigning extra staff to the review of BNT162b2. In doing so, Swissmedic is aiming to accelerate the review of BNT162b2 without compromising safety. Swissmedic is taking the same approach to other COVID-19 products, including the rolling review of AstraZeneca’s vaccine.
AstraZeneca became the first company to begin a rolling submission covering a COVID-19 vaccine in Switzerland earlier this month. The rolling submission model will allow Swissmedic to start reviewing the available data while the companies work to generate additional evidence.
MHRA lab joins global network to standardize COVID vaccine assessments
The Coalition for Epidemic Preparedness Innovations (CEPI) has added MHRA’s biological standardization wing to a centralized network designed to harmonize the evaluation of immune responses to COVID-19 vaccines.
Differences in the tests and techniques used to evaluate vaccines can affect the results of studies, complicating the task of comparing data generated at different sites. As part of the network, MHRA’s National Institute for Biological Standards and Control (NIBSC) will use the same reagents and methods as six other laboratories around the world to generate more comparable data.
“Samples from COVID-19 vaccine clinical trials can be shipped to one of seven sites around the world for uniform evaluation, allowing us to evaluate candidates in high-quality assays and identify which vaccine candidates may be performing well, in terms of the immune response, in clinical trials,” Melanie Saville, director of vaccine R&D at CEPI, said.
NIBSC has also signed up to work with CEPI on the creation of an international antibody standard against COVID-19. The project will enable vaccine manufacturers and regulators to compare immune responses triggered by vaccines to a global standard based on people who have recovered from the disease. CEPI is also working with NIBSC on standards for other diseases including Lassa fever.
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Euro Roundup: UK revs up for COVID vaccine approval.