October FDA, CDC Meetings On Coronavirus Vaccines Set Stage For Emergency Use Authorization

Even as the world — and investors — await a coronavirus vaccine, the timeline has become increasingly hard to gauge given clinical setbacks and the risks inherent with fast development. 

An analyst at Canaccord Genuity said a year-end timeline looks a possibility, going by two key events scheduled for this month. 

Upcoming FDA, CDC Meetings: With five SARS-CoV-2 vaccine candidates in pivotal Phase 3 trials, two meetings scheduled for late October could be the key, Canaccord analyst Arlinda Lee said in a note. 

The FDA's Vaccines and Related Biological Products Advisory Committee is scheduled to meet between 10 a.m. and 5 p.m. on Oct. 22 to discuss the development, authorization and/or licensure of vaccines to prevent COVID-19.

Also on tap is the CDC's Advisory Committee on Immunization Practices meeting. The AICP panel will meet Oct. 28-30, which is one of its customary three yearly meetings to review scientific data and vote on vaccine recommendations.

Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates

The Late-Stage Coronavirus Vaccine Programs: AstraZeneca plc's AZN ChAdOx1 nCoV-19, a chimpanzee adenovirus expressing SARS-CoV-2 spike, is in late-stage trials in the U.K., India and South Africa.

The late-stage study in the U.K. was voluntarily paused briefly due to an adverse event in one of the study participants.

The U.S. leg of the study remains halted, with a Reuters report suggesting the FDA has widened the scope of its probe into the halted trial.

Pfizer Inc. PFE and BioNTech SE – ADR BNTX, which are collaborating on a mRNA vaccine against SARS-CoV-2, recently amended its Phase 3 study protocol to increase the targeted enrollment from 30,000 to 44,000.

The increase was to accommodate a diverse population.

Recently, BioNTech announced plans to acquire Novartis AG's NVS GMP-certified manufacturing facility in Germany, which would increase its COVID-19 vaccine production capacity by up to 750 million doses per year.

Johnson & Johnson JNJ initiated a Phase 3 study of its coronavirus vaccine candidate JNJ-78436735 on Sept. 23.

JNJ-78436735 is manufactured using J&J's AdVac technology platform, which was used to develop and manufacture its Janssen unit's European Commission-approved Ebola vaccine.

The company has an early 2021 timeline for emergency use authorization. 

Moderna Inc MRNA has enrolled over 90% of the targeted enrollment number of 30,000 in the Phase 3 trial of its vaccine candidate mRNA-1273. The company is guiding for emergency use authorization by the end of 2020, although it doesn't expect authorization to come before the end of November.

Novavax, Inc. NVAX has an ongoing Phase 3 study of its NVX-CoV2373, a recombinant nanoparticle vaccine, in the U.K.

The company plans to start a late-stage study in the U.S. in October.

Posted In: CoronavirusCovid-19vaccineAnalyst ColorBiotechNewsHealth CareFDATop StoriesAnalyst RatingsGeneral