Britain’s regulator said on Thursday that modified coronavirus vaccines, intended for highly transmissible variants, could bypass new approvals and extended clinical trials.
Drug manufacturers should instead show “robust evidence” that the adjusted injection results in an immune response, says the Medicines and Health Products Regulatory Agency (MHRA), according to the new guidance from the ACCESS Consortium, developed in partnership with regulators in Canada, Switzerland and elsewhere.
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“Researchers are now better able to measure protection by looking at antibodies in the blood after vaccination, reducing the need to wait to see whether people in a test were infected with the disease or not,” says an MHRA statement published Thursday. -market. “This would significantly reduce the time needed for the modified vaccine to be ready for use.”
In addition to the effectiveness data, sponsors must demonstrate that the modified product is safe and meets quality standards. Data from original tests that support emergency authorizations and studies underway in real-world implementation may further support regulators’ decisions, the agency said.
Pfizer is testing whether a third dose can increase protection against emerging strains, and Moderna has developed a booster injection targeted against a worrying variant first detected in South Africa.
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MHRA said that a similar approach is used to clear annual modified flu vaccines amid changing strains.
Dr. Christian Schneider, scientific director at MHRA, said the goal is to get effective vaccines in the arms as quickly as possible, without compromising safety.
“The public must be confident that no vaccine will be approved unless the expected high standards of safety, quality and efficacy are met,” he added.