Coronavirus update: Moderna files for EUA; Novavax prepares for Phase 3

Anjalee Khemlani
·Senior Reporter
·4-min read

New positive and hopeful vaccine news arrived Monday, as the country continues to climb in positivity and cases, with hospitalizations and deaths following suit.

The U.S. surpassed 93,000 hospitalizations, setting the stage for a grim several weeks as hospitals face increased pressure on resources and staff.

Health experts worry about the two weeks following Thanksgiving, after airports reported busier security lines compared to recent months, anticipating surges in cases to follow.

But the “light at the end of the tunnel” is coming next month with two vaccine candidates, from Pfizer (PFE) and BioNTech (BNTX) as well as Moderna (MRNA), scheduled to be reviewed by the U.S. Food and Drug Administration (FDA).

The meeting on Pfizer’s vaccine on December 10, followed by Moderna’s on December 17 — in line with the week separation between the two emergency use filings— will likely result in authorizations. Within 24 hours after, both companies have vowed to begin shipment of the vaccines, in tandem with Operation Warp Speed.

President Donald Trump tweeted Monday that the FDA must act quickly on Moderna’s filing.

Hospitals are strained in the Midwest. (Graphic: David Foster/Yahoo Finance)
Hospitals are strained in the Midwest. (Graphic: David Foster/Yahoo Finance)

The shipping and distribution infrastructure will be the next piece of the process put to the test. USPS announced it was ramping up production of dry ice to help with Pfizer’s vaccine shipments. Meanwhile, American Airlines announced it began trial flights from Miami to South America in November to test thermal packaging and operation handling to ensure it can handle its part of the vaccine distribution process.

Meanwhile, Novavax (NVAX), another vaccine contender, is also moving ahead with its candidate. The company has fully enrolled its Phase 3 trial in the U.K., and anticipates the U.S. trial will begin in the coming weeks — following a more than month-long delay on the start date. The U.S. trial of AstraZeneca and Oxford is ongoing, with an early 2021 filing anticipated.

Despite the good news, much remains unknown about the vaccines’ effectiveness in a real world setting, as well as whether or not local level distribution of the vaccines will follow the guidelines set forth by the federal health agencies. It also remains to be known how long the vaccine’s protection will last. The most recent studies show natural protection has lasted at least eight months. But more studies are necessary as the pandemic continues.

The U.S. has reported more than 13 million cases Monday, marking a 3 million jump in 3 weeks. Positivity rates are plateauing or decreasing in most of the country, but experts warn that trend is likely to reverse.

Doctor in protective gloves & workwear filling injection syringe with COVID-19 vaccine.
Doctor in protective gloves & workwear filling injection syringe with COVID-19 vaccine.

Covid vaccines test trial tech

Clinical trials require a large amount of accurate and timely data gathering, and the pandemic has highlighted why that has become even more important this year. In addition to the usual observations of drug efficacy, more attention is being paid to age and race effectiveness. Companies like Pfizer and Moderna were able to provide unprecedented data that defines the distribution of vaccinated individuals.

Consultancy companies like Genpact are providing support to some of the current large global clinical trials for a COVID-19 vaccine, according to CEO Tiger Tyagarajan.

“This is a longer journey than a lot of people think it is,” Tyagarajan told Yahoo Finance.

Eric Sandor, business leader of pharmacovigilance at Genpact (G), said the company provides not just clinical trial analysis, but also in distribution of the vaccine.

This, he said, is important since trials and real world results can sometimes be very different. Tracking which batch of a vaccine, and which lot of that batch, is important to know in case of any serious issues.

The supply chain “won’t just be which batch went where. It will also be, ‘Am I getting different results with different batches in different parts of the world?’” he said.

But that’s where limits of current technology begin. The ongoing monitoring for adverse events — and knowing the profile of the persons experiencing adverse events — is not something technology can do as well right now, according to Genpact.

“The only way to attempt to deal with it is technology, is machines, along with humans. But humans won’t be able to do it by themselves,” Tyagarajan said.

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