This article originally appeared in FiercePharma and was written by Kyle Blankenship
The U.S. government has dumped billions into COVID-19 vaccine development and manufacturing as part of its Warp Speed initiative. Now, with vaccine makers moving rapidly toward approval, the administration has high hopes at least one shot candidate will start churning out doses within the next six weeks.
With federal backing, at least one COVID-19 vaccine will likely be “actively manufacturing” within the next four to six weeks, a senior Trump administration official told Reuters Monday.
Barring a surprise phase 3 readout and emergency use authorization from the FDA, that manufacturing would likely be “at-risk,” meaning the vaccine’s maker would be turning out doses without knowing whether they’ll pass regulatory scrutiny.
Operation Warp Speed has infused massive sums into its stable of chosen vaccine hopefuls in recent months, most recently a $1.6 billion deal last week with Maryland-based Novavax. The administration has also funded candidates from Moderna, Johnson & Johnson and AstraZeneca, and in June signed a $628 million deal with Maryland-based CDMO Emergent BioSolutions to secure manufacturing space to produce U.S. supply of selected shot candidates.
The senior official told Reuters that the “slate is not closed” on additional agreements and touted the government’s $450 million deal with Regeneron last week to help produce its antibody cocktail for COVID-19 as a hopeful route to treating the disease.
Players in the COVID-19 shot race have long said they would begin manufacturing as early as this summer despite warnings that a vaccine would likely not be available for public use before the end of the year.
But the Trump administration’s decision to place a timeline on manufacturing could stoke hopes that a viable vaccine might be in the offing earlier than expected. On the heels of Monday’s news, Novavax shares closed the day up nearly 10% at $104.32 per share.
Jefferies analysts said last month that there could be “perhaps multiple vaccines” that notch emergency use approvals by the fourth quarter given the administration’s massive investment in development and manufacturing, and President Donald Trump’s desire to announce a positive development by Election Day.
Pfizer and BioNTech—which aren’t part of the Warp Speed cadre, but plan to start phase 3 testing this month—say they could produce up to 100 million doses by the end of 2020 and 1.2 billion doses by the end of 2021 for global distribution.
While Novavax’s candidate isn’t the furthest along in human trials, the biotech has captured the U.S. government’s attention, and the company has been fleshing out its executive team to match, including hiring on a manufacturing chief to scale up its production chain.
The vaccine, which combines an antigen generated from the virus’ spike protein and the company’s proprietary Matrix-M adjuvant, is already in phase 1/2 testing, and the biotech expects to report early data this month.
If the data are promising, the company will move to the phase 2 portion of the study, where investigators will look at immunity, safety and disease reduction. The phase 3 efficacy study would enroll up to 30,000 participants and begin in the fall.
Like Moderna, Novavax has never brought a product to market, but it’s also advancing a late-stage flu vaccine candidate with plans to file for FDA approval soon.
Other candidates have gone steps further than Novavax to secure manufacturing space, with AstraZeneca already touting its ability to produce up to 2 billion doses of the University of Oxford’s adenovirus-based COVID-19 shot, AZD1222.
In June, AstraZeneca inked a $750 million deal with the Coalition for Epidemic Preparedness Innovations and Gavi, the Vaccine Alliance to manufacture and distribute 300 million doses of Oxford’s vaccine by the end of 2020. AZ also agreed to a licensing deal with the Serum Institute of India to provide 1 billion doses of the vaccine to low- and middle-income countries, with the goal of 400 million produced by year-end.
Meanwhile, Emergent will also play host to three vaccine candidates at its Baltimore Bayview facility after signing major deals.
Last week, J&J and Emergent signed a five-year work order worth at least $480 million to help produce the New Jersey-based drugmaker’s COVID-19 vaccine candidate. Emergent will provide “large-scale” drug substance manufacturing for J&J’s recombinant DNA shot beginning in 2021, starting with a $480 million order for the first two years of the deal. For the final three years, the partners would use a “flexible capacity deployment model” to provide annual batches as needed, Emergent said.
AstraZeneca had signed a similar deal with Emergent a month before, securing manufacturing capacity for $87 million. Emergent signed a placeholder deal with Novavax back in March for manufacturing space for its vaccine, but a work order has yet to be fleshed out.