The European Medicines Agency has issued guidelines to coronavirus vaccine manufacturers planning to adapt already authorized shots to new variants.
The EU regulator says the three authorized vaccines, made by Pfizer, Moderna and AstraZeneca, “provide protection against the variants currently prevailing in Europe.”
“However, it appears that with ongoing mutations and new variants emerging, authorized vaccines may need to be adapted to protect in a timely manner.”
The variant that is currently causing the most concern is one that first emerged in South Africa due to evidence that it may reduce the effectiveness of the vaccines. The so-called British and Brazilian variants also spread rapidly.
EMA says its experts have been working on the assumption that the modified vaccine would work in the same way as the original shot, except for a change in the part that triggers the body’s immune response.
It says ‘large-scale safety and efficacy studies are not required’, but at least one clinical trial is recommended in people who have not been vaccinated or infected with the coronavirus.
The agency also suggested that a study involve a small group randomly selected to receive the parent or the different vaccine to ensure that both cause similar immune responses.
It is said that the use of modified vaccines as a stimulant shot that is protected against variants should be investigated, and manufacturers are expected to provide data on the production quality of the customized vaccines.
Pfizer studies 3rd vaccine
The new guidelines come as Pfizer begins studying whether a third dose of its COVID-19 vaccine could provide protection against mutated versions of the virus, the company said Thursday.
The pharmaceutical giant said it would offer a third dose to 144 volunteers last year among participants in the earlier testing of the vaccine in the United States.
It wants to determine if an additional booster shot given six to twelve months after the first two doses will boost the immune system enough to ward off a mutated virus.
“Although we have not seen any evidence that the spread variant results in a loss of protection by our vaccine, we are taking several steps to take action and be ready if a strain resists the protection afforded by the vaccine, he said. Pfizer CEO Albert Bourla in a press release.
“This promotion study is critical to understanding the safety of a third dose and immunity to circulating strains,” he added.
Pharmaceutical giants working on updated recipes
At the same time, Pfizer and its German partner, BioNTech, are also adapting their vaccine prescription.
The companies said they were in talks with US and EU regulators about a “study to evaluate a variety-specific vaccine with a modified mRNA sequence. This study uses a new construct of the Pfizer-BioNTech vaccine based on the B.1.351 lineage, first identified in South Africa. “
Pfizer’s rival Moderna announced on Wednesday that it is ready to test experimental doses of its vaccine that are more in line with the South African variant of the virus.
Coronavirus vaccines by Pfizer and Moderna use a so-called mRNA technology that is easy to update. Their vaccines use a piece of genetic code for the ear protein that covers the virus so that the immune system can recognize and fight the right thing.
If a variant with a mutated ear protein emerges that the original vaccine cannot recognize, companies will exchange that genetic code for a better match – if and when regulators decide it is necessary.
But adapting to other coronavirus vaccines can be more complicated. The AstraZeneca shot, for example, uses a harmless version of a cold virus to carry the protein gene into the body. An update requires growing cold viruses with the updated spike gene.
The U.S. regulator said studies on updated COVID-19 vaccines do not have to be as large or long as for first-generation shots. Instead, several hundred volunteers were able to receive experimental doses of a modified vaccine to see if their immune systems responded in the same way as the original survey.