The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced it will fast-track approvals for COVID-19 vaccines that have been modified to address new variants of the virus.
The new guidance from the ACCESS Consortium – a coalition of regulatory authorities from the UK, Australia, Canada, Singapore and Switzerland – outlines what vaccine makers will need to provide to gain approval for a modified vaccine.
This includes providing ‘robust’ evidence that a modified vaccine produces an immune response against a COVID-19 variant.
However, the guidance adds that ‘lengthy’ clinical studies that do not add to the regulatory understanding of a vaccine’s safety, quality or effectiveness would not be required.
The new guidance highlights researchers’ improved capabilities for measuring protection by looking at antibodies in the blood following vaccination.
This negates the need to wait for participants within a clinical trial setting to potentially become infected with COVID-19, the MHRA said.
Vaccine makers will also be expected to provide evidence demonstrating that a modified vaccine is safe and of ‘expected quality’.
Additional data from the original clinical trials and ongoing studies on real-world use of a vaccine could also be used to support regulatory decisions.
The MHRA says this approach is ‘tried and tested’, as it is the same process used for the seasonal flu vaccine, which requires annual modifications.
“Our priority is to get effective vaccines to the public in as short a time as possible, without compromising on safety. Should any modifications to authorised COVID-19 vaccines be necessary, this regulatory approach should help to do just that,” said Christian Schneider, chief scientific officer of the MHRA.
“The public should be confident that no vaccine would be approved unless the expected high standards of safety, quality and effectiveness are met,” he added.
A number of vaccine makers are working on modified vaccines to address new and emerging variants.
This includes Moderna, which is developing a variant-specific vaccine candidate – mRNA-1273.351 – against the B.1.351 variant discovered in South Africa.
The company is also developing a multivalent booster candidate, mRNA-1273.211, that will combine Moderna’s authorised vaccine with the mRNA-1273.351 candidate in a single vaccine.
Moderna will also develop a third dose of mRNA-1273 as a booster at a dose level of 50µg.
Pfizer/BioNTech also recently initiated a study to evaluate the safety and immunogenicity of a third dose of their COVID-19 vaccine.
The aim of this study is to understand the effect of a booster dose on immunity against COVID-19 caused by the circulating and potential newly emerging variants.
The companies are also in ongoing discussions with regulatory authorities regarding a clinical study to evaluate a variant-specific vaccine that would have a modified mRNA sequence.
This study would use a new construction of the Pfizer/BioNTech vaccine based on the B.1.351 variant, according to the companies.
Oxford University is also working on a second-generation version of its AstraZeneca-partnered vaccine that will be adapted to target variants with mutations similar to B.1.351.