- The first novel coronavirus vaccine to reach human trials in the USA. USA It comes from Moderna. It's an mRNA drug that promises, according to a company announcement that yielded partial results.
- Moderna's announcement of the coronavirus drug was incomplete and sparked some criticism from scientists who wanted to access the full dataset.
- Dr. Anthony Fauci has just expressed his own dissatisfaction upon seeing the Moderna press release, but reiterated his belief that the treatment is promising.
- Fauci did the same thing himself a few weeks ago when he published preliminary results on remdesivir without waiting for the full study to be ready.
When Dr. Anthony Fauci announced the promising results of a massive remdesivir trial conducted by the National Institutes of Health, he did so without waiting for proper research to be published in a medical journal. The results of the remdesivir study were not released until several weeks later, with the same conclusions Fauci offered from the White House in late April. But Fauci is now unhappy with vaccine maker Moderna because of the way it announced promising results for what could end up being one of the first vaccines for the new coronavirus.
Moderna announced a few days ago that the vaccine candidate she has been working on has generated neutralizing antibodies that can block SARS-CoV-2 replication. But the data was not complete and came through a press release instead of a published study. Moderna's shares soared and the company announced a new public offering hours later, through a different announcement. Then came news that some executives were selling shares at the same time, in what was a previously planned move. There is no indication that the laws were violated, but it certainly wasn't a good look for the company.
The world noted that Fauci and NIAID were silent on the matter, even though they partnered with Moderna for this candidate for the coronavirus vaccine. The drug is one of the first to have reached Phase 1 trials, and certainly the first vaccine candidate to inoculate American volunteers. It is the same drug that Fauci said a few weeks ago that it could be ready by early 2021.
The infectious disease expert explained in a follow-up interview that the Moderna ad gave good news. The drug appears to be safe and may elicit the immune response necessary to block the coronavirus.
Fauci finally addressed Moderna's recent vaccine revelations in a new interview with Stat. "I didn't like that," Fauci said as he doubled down on the fact that Moderna's partial data is still good enough. "What we would have preferred to do, frankly, is wait until we have the data for all of Phase 1, which I understand is quite similar to the data they showed, and publish it in a reputable magazine and show all the data."
He added that the company was excited when they saw the positive data and put it all in a press release.
As a reminder, Fauci published study data remdesivir several weeks before it was published in an accredited journal and before all of that data was released to the world. Unlike Moderna's incomplete dataset, Fauci relayed most of the study information, including the fact that remdesivir cannot reduce COVID-19 mortality. He also said that another medication along with remdesivir may be needed to improve coronavirus therapies.
Once published, the remdesivir study received some criticism. Some said the study shouldn't have ended prematurely for some placebo patients, and others noted that the study shifted its goals in half.
That said, there are differences between the early Fauci and Moderna ads. The doctor participates in the White House COVID-19 working group, and is able to make informed decisions and announcements about new therapies. The remdesivir conclusions were apparently ready, compared to Moderna's, which only had data from eight of the 45 volunteers. The remdesivir study was also conducted worldwide, including more than 1,000 patients.
Furthermore, Fauci's comments came at a time when the controversial hydroxychloroquine drug may have been more popular with the public. That is a drug that has yet to show promise in COVID-19 treatment. In fact, it could worsen coronavirus infections. Fauci's remdesivir arguments were based on scientific data, even if they were not published in a magazine. They offered the public a different perspective on how to approach new drug therapies for a disease that has been ravaging the country. Fauci made it clear more than once that hydroxychloroquine should not be used without supporting data, often answering questions about Trump's strange love for hydroxychloroquine. However, many people were quick to buy the antimalarial for the use of COVID-19.
In the interview with StatFauci also addressed a different vaccine candidate who is being tested in Germany and the United States. That is Pfizer's mRNA drug made by the German company BioNTech, which could be ready by October. "The Pfizer is very similar to that of Moderna," said Fauci. "It is an mRNA vaccine. I am sure that Pfizer will get as good results as the Modern vaccine. There is no reason to believe that one will be different from the other."
The NIAID director said the 12 to 18 months needed for a widely distributed coronavirus vaccine are "aspirational, but they certainly are feasible."
He continued: "The only thing that is the great unknown to me is that, will it be effective? I think we could do it within the time frame that I have outlined. But there is no guarantee that it will be effective."