- Drug makers Sanofi and GlaxoSmithKline are set to receive up to $2.1 billion in funding for their potential coronavirus vaccine.
- The funding comes from Operation Warp Speed, the Trump administration's effort to deliver 300 million doses of a safe, effective coronavirus vaccine by January 2021.
- Sanofi recently moved up the date of its first clinical trial to September.
- Other candidates like Moderna's have already reached phase 3 of their trials.
- For more stories like this, sign up here for our healthcare newsletter Dispensed.
The US is assembling an army of vaccine candidates in the hopes that one will be successful in warding off the coronavirus. The latest candidate to get government funding hails from two of the world's largest vaccine makers: Sanofi and GlaxoSmithKline.
On Friday, the companies announced that their protein-based vaccine will receive funding from Operation Warp Speed, the Trump administration's effort to deliver 300 million doses of a safe, effective coronavirus vaccine by January 2021. The program's goal is to manufacture promising vaccine candidates in large quantities while clinical trials are still ongoing.
Under the new partnership, Sanofi and GSK will receive up to $2.1 billion from the US government. More than half of that money will go toward developing the vaccine and advancing clinical trials, while the rest will go toward manufacturing and delivering 100 million initial doses. After that, the government will have the option to acquire an additional 500 million doses.
"The portfolio of vaccines being assembled for Operation Warp Speed increases the odds that we will have at least one safe, effective vaccine as soon as the end of this year," Secretary of Health and Human Services Alex Azar said in a statement on Friday.
Read more: There are more than 160 coronavirus vaccine candidates being developed. Here's how the top drugmakers see the race for a cure playing out in 2020.
Other vaccines backed by Operation Warp Speed include candidates from Oxford and AstraZeneca, Johnson & Johnson, Merck, Moderna, Novavax, and Pfizer.
A race to the finish line
Twenty-five potential coronavirus vaccines are now being tested on humans in clinical trials. Three companies — AstraZeneca, Moderna, and Pfizer — hope to have a vaccine ready for emergency use this fall. All three companies have also published early data showing that their vaccines generated immune responses without causing serious side effects.
Moderna's mRNA vaccine candidate became the first to enter a late-stage clinical trial in the US on Monday. The company's CEO, Stephane Bancel, previously told Business Insider that data from the trial could be ready as early as October. The next step would be securing emergency approval from the FDA to administer the vaccine to people who face a higher risk of severe infection. Young, healthy people could get the vaccine as early as next spring.
The timeline would be unprecedented, but many other candidates are racing to meet a similar deadline.
In a press release, Sanofi said it expects to start its first clinical trial in September, which would be followed by a phase 3 trial by the end of the year, assuming initial results are positive. From there, the company could seek emergency FDA approval in the first half of 2021.
Read more: The first look at human data from the coronavirus-vaccine front-runners is in. Here's how Pfizer, Moderna, and AstraZeneca stack up as they race to have their shots ready this fall.
Sanofi is using the same technology as its flu vaccine
Unlike some companies working on coronavirus vaccines, Sanofi is already a key player in the industry: The company produces around 200 million doses of flu vaccine every year. Now, it's using the same technology in its attempt to induce immunity to the coronavirus.
The company's vaccine contains a genetic replica of the spiky protein on the surface of the coronavirus. It also contains an adjuvant (a compound that could boost an immune response) from GSK. This combination is designed to create more lasting immunity to the virus, though booster shots may still be necessary.
The investment from Operation Warp Speed comes roughly a month after Sanofi announced that it would bump up its timeline for a clinical trial from a December start date to September. The vaccine previously trailed behind others, but it's further along than Sanofi's other candidate: an mRNA vaccine produced in collaboration with Translate Bio. That vaccine could start phase 1 trials by the end of 2020.
The FDA has never allowed the emergency use of a vaccine before, and drugmakers still face their biggest hurdles ahead: showing that their vaccines can produce long-lasting immunity in humans, ramping up production, and distributing their serums across the world.
"We should know as we get into the mid to late fall — early winter, but probably late fall — whether we have candidates that really are safe and effective," Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said on July 16. "I hope and anticipate that we will have one or more."
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