Via: https://www.biospace.com/article/u-s-government-banks-on-vaccines-from-multiple-companies-to-end-pandemic/
Published: Dec 09, 2020 By Alex Keown
The U.S. Food and Drug Administration (FDA) is on the cusp of approving the first vaccines against the novel coronavirus, delivering a potential end to the pandemic. Although vaccines will be available pending approval, there are questions as to how many people will quickly receive the vaccine and when more will be available.
The U.S. government has struck a number of deals with vaccine makers to acquire millions of doses. Some of those deals though are for vaccines that have yet to pass clinical muster, which means they will not be available for several months, at best. Of the two vaccines that are close to receiving Emergency Use Authorization from the FDA, Pfizer and BioNTech’s BNT162b2 and Moderna’s mRNA-1273, the government has secured 200 million doses. Both vaccines are two dose regimens, which means the preventative medication will only be able to inoculate 100 million people. The government reportedly passed on Pfizer’s offer for additional doses earlier this summer. The company said it will not likely produce enough doses to meet U.S. demand until the summer of 2021. The U.S. does have a deal with Moderna for additional doses, but it remains to be seen how many doses the company will have available due to strong international sales. According to Politico, the U.S. government has secured roughly 800 million doses from six manufacturers, but some of those will not be available for months, if clinical studies pan out.
While some Americans will likely receive a vaccine over the next few months, the bulk of vaccinations will not likely happen until late spring or early summer. And that means vaccines that could be distributed are from companies like AstraZeneca, Novavax and Johnson & Johnson. But none of those companies are close to receiving EUA for their vaccines. AstraZeneca is likely closest, but the efficacy of its preventative treatment is not as high as the mRNA medications developed by Pfizer and BioNTech and Moderna. On Tuesday, it was reported that AstraZeneca’s vaccine is safe and has an efficacy of about 70%. However, there are some questions about how well the medication will work in people over 55. In contrast, Pfizer and BioNTech’s mRNA vaccine, BNT162b2 demonstrated a 95% efficacy in clinical trials and Moderna’s vaccine demonstrated 94% efficacy. The 70% rating is well above the 50% benchmark for vaccine approval previously set by the FDA. Final results from the clinical trial are not expected until after the turn of the year and EUA would likely occur in February or early March. Johnson & Johnson’s vaccine could also be approved within the first few months of 2021. J&J anticipates interim data for its single-dose vaccine by the end of January.
If those do receive EUA, Moncef Slaoui, the chief scientific officer for Operation Warp Speed, told Bloomberg that the J&J and AstraZeneca vaccines could provide about 150 million to 200 million shots in the first quarter of 2021. That could immunize 110 million to 150 million people, if the doses are evenly split between J&J’s single-dose vaccine and Astra’s two-dose regimen, Blomberg said. By banking on multiple vaccine makers to provide treatment, Slaoui said the nation should be able to reach the levels of herd immunity protection it needs in the pandemic battle.
“Already with this portfolio, I feel confident that we can cover the U.S. population within the first half of 2021,” Slaoui said, according to Bloomberg. He added that most Americans who wanted a vaccine should be able to receive one by June.
Slaoui’s comments are similar to those of President Trump, who has promised that most Americans will be vaccinated by May. With concerns about the availability of vaccines over the next few months, and responding to criticism of not securing additional doses from Pfizer, Trump signed an Executive Order on Tuesday to secure doses for Americans before companies can deliver vaccine doses to other government health agencies they have struck deals with. It is unclear if there is any real enforcement of this EO.
On Monday, the first doses of Pfizer and BioNTech’s vaccine began to be administered to U.K. citizens following authorization in that country last week.
Via: https://www.biospace.com/article/u-s-government-banks-on-vaccines-from-multiple-companies-to-end-pandemic/
Published: Dec 09, 2020 By Alex Keown
