FDA Aims for Quick Review of Omicron Vaccines andDrugs
Dow Jones - Dec 03, 2021 09:15:00
A priority would be ensuring Omicron shots worksafely before use at sites such as this one in Washington, D.C. (JimWatson/Agence France-Presse/Getty Images)
The Food and Drug Administration is laying thegroundwork for the rapid review of Omicron-targeted vaccines and drugs if theyturn out to be needed, according to people familiar with the matter.
The agency, building on rules established earlierthis year to assess shots and treatments, has been meeting with drugmakers andsetting guidelines for the studies and data needed to swiftly evaluate productstargeting the new Omicron Covid-19 variant, the people said.
The FDA wants to be sure Omicron shots andtherapies work safely and can be made correctly before authorizing their use,while moving as quickly as it can to conduct the assessment to aid efforts tostay ahead of the variant, according to people familiar with the matter.
Under the rules that the FDA is putting intoplace, drugmakers working on new vaccines would be expected to meet standards similarto those required for authorization of boosters, a person familiar with thematter said.
For vaccines, the companies wouldn’t have toconduct large, lengthy trials enrolling thousands of subjects that wait for acertain number to catch symptomatic Covid-19. Instead, they could, for example,study the immune responses in a few hundred subjects.
Drugmakers would need about three months todevelop and test the new vaccines, a person familiar with the matter said. Thenthe companies would seek authorization of the shots through an expedited reviewprocess, and it would take the FDA one to two weeks to make a decision,according to the person.
Pfizer Inc. Chief Executive Albert Bourla saidthis week that the company and its partner BioNTech SE could have the vaccinesready in 100 days, while Moderna Inc. has said the company can advance newcandidates to clinical testing in 60 to 90 days.
The preparations are another element of the rapidresponse to Omicron . Since the new variant was identified by South Africascientists last week, health authorities and drug researchers have sought tofigure out the threat it could pose to vaccines, drugs and people.
Drugmakers would need about three months todevelop and test the new vaccines for use at facilities including this site inNew York City. (Spencer Platt/Getty Images)
Testing to determine whether the new variant canevade current vaccines and medicines is continuing, and expected to takeanother week or two. To be prepared, drugmakers such as Moderna along withPfizer and BioNTech are already moving to develop Omicron-targeted shots andtreatments.
President Biden said Monday that he is directingthe FDA and the Centers for Disease Control and Prevention to use “the fastestprocess available without cutting any corners for safety” to authorize newvaccines and make them available if needed.
Acting FDA Commissioner Janet Woodcock saidTuesday that the agency would work quickly with companies to develop and testvaccine modifications if they are determined to be necessary.
The FDA had limited the use of some monoclonalantibody treatments depending on their effectiveness against circulatingvariants, Dr. Woodcock said, and is working with pharmaceutical companies todetermine the impact of the Omicron variant on treatments.
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Scientists and vaccine makers are investigatingOmicron, a Covid-19 variant that has been detected in many countries afterspreading in southern Africa. Here is what we know as the U.S. and othersimplement travel restrictions. Photo: Fazry Ismail/EPA/Shutterstock
By directing what kind of studies and data itwill need to evaluate new medicines, the FDA helps drugmakers save timedesigning studies and gathering the evidence the agency wants to see for itsevaluations.
Drugmakers will also know what kind of evidencethe agency wants to see to make sure the companies can manufacture the newproducts correctly, another typically time-consuming part of the FDA reviewprocess.
The FDA’s Omicron guidance stems from preliminarywork to pave the way for variant-specific vaccines and drugs completed earlierthis year. The companies have tested vaccines for other variants, but none hasbeen rolled out.
Under the updates, the agency would clearproducts that were already authorized but are being tweaked to fight Omicronwith less data than required for the initial authorization, a person familiarwith the matter said.
“It’s a way of looking at the strength of thebody’s response, that gives you answers more quickly,” said Jesse Goodman , aprofessor of medicine at Georgetown University and a former FDA chief scientist,speaking generally about such studies.
Drugmakers working on new vaccines would beexpected to meet standards similar to those required for authorization ofboosters. (Jim Watson/Agence France-Presse/Getty Images)
The late-stage studies that the agency reviewedbefore authorizing Covid-19 vaccines were far larger, with Pfizer-BioNTechenrolling more than 43,000 people and Moderna enrolling about 30,000 people .And the studies looked at how many vaccinated people compared with volunteerson placebo developed symptomatic Covid-19, rather than their immune responses.
The FDA is still determining how much theeffectiveness of current vaccines would need to drop to merit authorizing newones, a person familiar with the matter said.
Agency officials have been discussing the matterwith Pfizer and BioNTech, as well as with Moderna and Johnson & Johnson ,companies and U.S. officials have said.
In addition to establishing their ownrequirements, U.S. officials expect to be in contact with health authoritiesfrom other countries and the World Health Organization before deciding whethera new vaccine is needed, a person familiar with the matter said.
They will discuss what new candidates wouldtarget because the vaccine makers aren’t likely to make different shots fordifferent places, one of the people familiar with the matter said.
The FDA said it believes that PCR and rapid testswill continue to work well, but is prepared to adjust course if needed.
Stephanie Armour and Jared S. Hopkins contributedto this article.
Write to Felicia Schwartz [email protected]
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