Three separate coronavirus vaccine Phase 3 trials will run in the US this summer, under government supervision.
Dr. Anthony Fauci confirmed that the government will fund advanced stages of testing for two of the leading vaccine candidates, Moderna’s vaccine and another one from AstraZeneca and Oxford.
Johnson & Johnson’s COVID-19 vaccine drug will also be included and funded by the government, assuming it clears Phase 1 experiments that have yet to begin.
Vaccines for the novel coronavirus have shown promising results in animal and human trials so far and there’s real hope some of them could be available to use as soon as this year. The drugs still need to clear the final stages of clinical trials and prove they can prevent COVID-19 infections before they can be approved for general use. But coronavirus vaccine research has advanced at such an incredible speed that the final trial phases will take place this summer for some of the vaccines. There are more than 130 vaccine candidates in the works right now, with around 10 of them having reached various stages of human trials. Dr. Anthony Fauci has now confirmed that three of these will be used in extensive Phase 3 trials funded by the US government.
“The coronavirus vaccine effort is progressing very well, and we expect more than one candidate vaccine to be in advanced clinical testing by early summer,” Fauci told CNN. “This is good news for the overall coronavirus vaccine effort.”
The government will fund Phase 3 studies for all three chosen vaccines, the director of the National Institute of Allergy and Infectious Diseases (NIAID) said. Two of them are hardly surprising, as they’ve made the news quite a few times in the past few months. Moderna will be the first to kick off Phase 3 trials in July, followed by AstraZeneca’s Oxford candidate a month later.
The third vaccine comes from a company that has yet to announce any vaccine results, and that’s because Johnson & Johnson hasn’t even started Phase 1 trials. According to The Wall Street Journal, J&J will start the first human trials in the second half of July and will move to Phase 3, pending the outcome of the first stage and subsequent regulatory approval.
Surprisingly, Pfizer and BioNTech aren’t included in the NIAID program. The two companies partnered on Phase 1 trials in Germany and the US a few weeks ago, with the BioNTech vaccine being a genetic drug similar to Moderna’s concept. A person familiar with the progress on this vaccine told The Journal that Pfizer could begin its Phase 3 trial in July.
AstraZeneca and Oxford already announced their own Phase 3 study in the UK and other regions. Recent reports noted that there might not be enough sick people in Britain anymore, which could slow down Phase 3 research for the drug.
Each of the three US-sponsored vaccine studies will include 30,000 people who will receive either the experimental drug or a placebo. More than 50 sites will be enrolled in the study, most of them in the US. Other countries may also be chosen depending on how the disease evolves. The researchers will want to conduct the studies in locations where the virus keeps spreading. That’s the only way to ensure that volunteers can be exposed to the pathogen so they can verify the drug works.
The studies will look at whether the vaccines can block the infection, whether they’re safe for participants, and whether they can be advanced to standard COVID-19 prevention protocols. If the drugs pass these final hurdles, they may be available for emergency use at some point in the fall or winter.
What’s also important to note is that an independent committee will monitor the safety of the drugs and will compare how the vaccines perform. They’ll also look at whether some drugs are better for specific subpopulations, The Journal says. This is in line with recommendations from Fauci and other experts who wrote a paper on how to fast-track coronavirus vaccine development safely and efficiently.
The point of the extensive study isn’t to single out just one vaccine. Fauci and others also explained that the world needs as many shots on goal as possible, and more than one vaccine candidate will hopefully prevent COVID-19 infections. The more vaccine options we have, the easier it’ll be to deploy them at scale in the coming years.
The manufacturing and distribution logistics are yet to be ironed out, but work has already started. AstraZeneca already obtained orders for hundreds of millions of doses from the UK, US, and other regions. The US government alone invested $1.2 billion for 300 million doses.
Last week, Fauci said the US should soon have 100 million doses of one of the candidates, as manufacturing will likely start before Phase 3 trials are completed. He explained that it’s a financial risk, but it could speed up delivery if the drug proves to be effective.