The European Medicines Agency has published guidelines for coronavirus vaccine manufacturers that plan to adapt already authorized vaccines to new variants.
The EU regulator says the three authorized vaccines, developed by Pfizer, Moderna and AstraZeneca, “provide protection against variants that are currently prevalent across Europe.”
“However, it appears that with continued mutations and new emerging variants, it may be necessary to adapt authorized vaccines in time to ensure continued protection.”
The variant of most concern today is the one that first emerged in South Africa due to tests that may decrease the effectiveness of vaccines. The so-called British and Brazilian variants are also spreading rapidly.
EMA says its experts worked on the assumption that the fitted vaccine would work the same way as the original vaccine, except for a change in the part that triggers the body’s immune response.
He says “large-scale safety and efficacy studies are not needed,” but at least one clinical trial is recommended in people who have not been vaccinated or infected with the coronavirus.
The agency also suggested a study with a small group randomly selected to receive the parent or vaccine variant to ensure that both trigger similar immune responses.
Studies on the use of adjusted vaccines as protection against variants are said to be conducted and manufacturers are expected to provide data on the production quality of adjusted vaccines.
Pfizer studying the third vaccine
The new guide comes as Pfizer began studying whether a third dose of its COVID-19 vaccine could offer protection against mutated versions of the virus, the company said Thursday.
The pharmaceutical giant said it will offer a third dose to 144 volunteers among participants in initial vaccine testing in the United States last year.
He wants to determine if an additional booster shot given six to twelve months after the first two doses would boost the immune system enough to prevent a mutated virus.
“While we have not seen any evidence that circulating variants result in a loss of protection provided by our vaccine, we are taking several steps to act decisively and be prepared in case a strain is resistant to the protection offered by the vaccine. “, he said. Pfizer CEO Albert Bourla in a press release.
“This booster study is critical to understanding the safety of a third dose and immunity against circulating strains,” he added.
Pharmaceutical giants working on up-to-date prescriptions
In parallel, Pfizer and its German partner, BioNTech, are also adjusting the vaccine recipe.
The companies said they were in talks with U.S. and EU regulators about a “study to evaluate a variant-specific vaccine that had a modified mRNA sequence. This study would use a new construction of the Pfizer-BioNTech vaccine based on the lineage B.1.351, first identified in South Africa “.
Pfizer’s competitor, Moderna, already announced Wednesday that it was ready to test experimental doses of its vaccine that would best match the South African variant of the virus.
Pfizer and Moderna coronavirus vaccines use a technology called mRNA that is easy to upgrade. Their vaccines use a piece of genetic code for the ear protein that coats the virus, so the immune system can learn to recognize and fight what’s real.
If a variant occurs with a mutated spike protein that the original vaccine cannot recognize, companies would change this piece of genetic code to get a better match, if and when regulators decide it is necessary.
But modifying other coronavirus vaccines can be more complex. The AstraZeneca trait, for example, uses a harmless version of a cold virus to transport this ear protein gene to the body. An upgrade would require the growth of cold virus with the updated ear gene.
The U.S. regulator said updated COVID-19 vaccine studies should not be as large or long as for the first generation of shots. Instead, a few hundred volunteers could receive experimental doses of a fitted vaccine, to see if their immune system reacts similarly to the updated version of the original.