The US FDA is establishing the framework for a quick assessment of vaccines and drugs against Omicron if needed, according to sources familiar with the situation.

Based on rules established earlier this year to evaluate shots and treatments, the agency has been meeting with drugmakers and developing guidelines for the studies and data needed to quickly evaluate products targeting the new Omicron Covid-19 variant, they pointed out.

According to people familiar with the matter, the FDA wants to ensure that Omicron shots and therapies are safe and can be administered correctly before approving their use. The agency is also working as quickly as possible to complete the assessment in order to aid efforts to stay ahead of the variant’s spread.

Drugmakers working on new vaccines will be expected to achieve standards comparable to those required for the approval of boosters.

Companies would not have to run massive, lengthy trials recruiting thousands of individuals and waiting for a certain number of them to catch symptomatic Covid-19 in order to develop vaccines. Instead, they could look into the immunological responses of a few hundred people.

In addition, after three months of testing, they can submit an application to the FDA for approval of the shots through an expedited review process, which would take one to two weeks to reach a decision, according to the source.

In a recent interview, Pfizer Chief Executive Albert Bourla stated that the business and its partner BioNTech may have the vaccines available in 100 days, while Moderna has stated that it can progress new candidates to clinical testing in 60 to 90 days.

Since the discovery of the new strain by scientists in South Africa last week, health authorities and drug researchers have been working to determine what kind of threat it might pose to vaccines, treatments, and humans in general.

Testing to ascertain whether the new variety may avoid the effects of current vaccines and medications is still ongoing and is expected to take another week or two to complete.. Drug companies like as Moderna, Pfizer, and BioNTech are already working on developing Omicron-targeted injections and treatments in order to be prepared for the future.

President Biden announced on Monday that the FDA and the Centers for Disease Control and Prevention will follow “the fastest process available without cutting any corners for safety” to approve new vaccines and make them available if they are needed.

Acting FDA Commissioner Janet Woodcock said on Tuesday that if vaccine tweaks are found to be necessary, the agency will work rapidly with firms to develop and test them.

According to Dr. Woodcock, the FDA has limited the use of several monoclonal antibody treatments based on their efficacy against circulating variations and is working with pharmaceutical companies to establish the impact of the Omicron variant on treatments.

A person familiar with the situation said that, in addition to developing their own guidelines, US officials are in touch with health officials from other nations and the World Health Organization before deciding for deciding if a new vaccine is required.

The FDA has stated that it is confident that PCR and rapid testing will continue to perform well, but it is prepared to change direction if the situation demands.

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