Medicines regulator says it is first in world to approve Valneva product
As the Covid pandemic swept the world, scientists began developing vaccines against it, with the Pfizer/BioNTech jab being the first in the UK to be authorised for emergency use by the MHRA in 2020. Since then the MHRA has approved the Moderna, Oxford/AstraZeneca, Janssen and Novavax vaccines, although, according to NHS England, Janssen and Novavax are not currently available.
The UK’s independent medicines regulator was the first in the world to approve the Valneva product, the MHRA said. Unlike the other approved Covid jabs, the Valneva vaccine is an inactivated whole-virus vaccine, which means the live virus was grown in a laboratory, rendered unable to infect cells, then administered to people to trigger an immune response.
The MHRA said this approach was already being used for flu and polio vaccines and experts have previously suggested that Covid jabs based on the whole virus may result in a broader immune response than those that involve only the spike protein, and may work better against new variants.
Results released by Valneva in October suggested the vaccine could be as effective as the Oxford jab. In addition, it is stable when stored in a standard refrigerator, which could make it easier to distribute than some other Covid jabs.
Prof Sir Munir Pirmohamed, the chair of the independent Commission on Human Medicines, said the commission and its Covid-19 expert working group had carefully considered the evidence and advised that the benefit-risk balance was positive. “The vaccine is approved for use in people aged 18 to 50 years, with the first and second doses to be taken at least 28 days apart.”
Prof Adam Finn, a member of the Joint Committee on Vaccination and Immunisation and the chief investigator on the Valneva clinical development programme, said that while the jab had been approved it was unlikely to be available in the UK soon, as the government had cancelled its contract to buy the vaccine in September.
However, he said the jab could prove more acceptable than others to some people. “The people who could theoretically benefit from it now are unvaccinated 18- to 50-year-olds who want immunisation but are hesitant about currently available vaccines,” he said, adding that the Novavax jab could also appeal to this group.
However, there was another hurdle. “In the UK, no one has yet been offered any choice as to which vaccine they receive,” said Finn, a professor of paediatrics at the University of Bristol.
On Thursday it was also revealed that the MHRA had approved extending the use of the Moderna Covid jab to six- to 11-year-olds in Great Britain, an age group for which it is already authorised in Northern Ireland. At present, children aged five to 17 are only offered the Pfizer/BioNTech vaccine, which is based on similar mRNA technology.
Dr June Raine, the MHRA’s chief executive, said the Moderna vaccine was safe and effective in six- to 11-year-olds, but that the age group was included in the ongoing safety surveillance of all Covid jabs.
“It is for the Joint Committee on Vaccination and Immunisation (JCVI) to advise in due course on whether six-to-11s should be offered vaccination with the Covid-19 vaccine made by Moderna as part of the deployment programme,” she said.
The number of deaths involving coronavirus registered each week in England and Wales has continued to increase, although levels remain well below those reached during previous Covid waves.
Source: www.theguardian.com/world/2022/apr/14/valneva-approved-to-be-uks-sixth-covid-vaccine