During his Thanksgiving message to US troops, US President Donald Trump announced coronavirus vaccines delivery will start as early as next week. He added that frontline workers, medical personnel, and senior citizens will take priority.
Credit to Him, Not Biden
Trump argued that President-elect Joe Biden, shouldn’t take any of the credit for the vaccines. He referred to the vaccines as a “medical miracle” and that he made it happen.
“Joe Biden failed with the swine flu, H1N1, totally failed with the swine flu,” Trump said, referring to the 2009 outbreak. “Don’t let him take credit for the vaccines because the vaccines were me and I pushed people harder than they’ve ever been pushed before and we got that approved and through and nobody’s ever seen anything like it.”
Ahead of FDA Reviews
The President’s vaccine comments might refer to a scheduled December 10 meeting of the Food and Drug Administration. FDA officials will review an emergency use authorization (EUA) application made by Pfizer and BioNTech. The companies reported that their BNT162b2 candidate vaccine showed 95% effectiveness. The full effects of the vaccine happened 28 days after the first dose. Efficacy remained consistent among various age, gender, and ethnic groups. In addition, a 94% effectiveness rate registered in adults over 65 years of age. Even better, subjects reported few side effects.
The results encouraged Pfizer and BioNTech to apply for EUA within days after releasing its results report. The companies also plan to share results with regulatory agencies all over the world. Pfizer estimates they can produce up to 50 million vaccine doses in 2020. Then, production will increase to 1.3 billion doses by 2021. By then, coronavirus vaccines delivery all over the world shouldn’t be a problem.
December 10 Review
Pfizer submitted the application for EUA on November 20. CEO Albert Bourla gave a video statement for the occasion. “Today, we were able to submit a very robust dataset that we believe meets, and in many cases, exceeds the FDA’s high standards, said Bourla. He pointed out that the EUA for the vaccine was filed 248 days after the two firms entered into their development collaboration. “It is with great pride and joy – and even a little relief – that I can say that our request for emergency use authorization for our COVID-19 vaccine is now in the FDA’s hands. This is a historic day; a historic day for science and for all of us,” he said.
The FDA set a December 10 date for the Pfizer/BioNTech EUA. The Vaccines and Related Biological Products Advisory Committee will meet to review the application. FDA will allow live coverage of the meeting on Facebook, Twitter, and YouTube. In addition, the agency website will host a Livestream of the proceedings. FDA Commissioner Dr. Stephen Hahn said: “The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and stands ready to do so as soon as a EUA request is submitted. While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner.”
Moderna to Apply for EUA As Well
Meanwhile, Moderna also came up with a coronavirus with a 94.5% effective rate. However, they can file for EUA by late November at the earliest. The company is completing its two-month safety data as part of FDA requirements. Moderna vaccinated their 15,000th subject on September 26. Consequently, the earliest time to complete the safety data is November 25. Meanwhile, Moderna CEO Stéphane Bancel said that he does not expect full approval for their vaccine until March 2021 earliest.
The biotechnology company is optimistic their vaccine will secure approval. In a press release, Bancel wrote that they are “actively preparing for the launch of mRNA-1273 and we have signed a number of supply agreements with governments around the world. Moderna is committed to the highest data quality standards and rigorous scientific research as we continue to work with regulators to advance mRNA-1273.”
Jumped the Gun
Trump may have jumped the gun on coronavirus vaccines delivery schedules, but this remains good news. The promise of vaccines by next week is wishful thinking. However, the December 10 review of Pfizer/BioNTech is potentially a watershed event. We’ve waited for nine months to come up with a vaccine, what’s a few more days?
Watch as CNBC covered the candidate’s debate last October where President Donald Trump predicted that coronavirus vaccines will become available by the end of the year:
Do you agree that the coronavirus vaccines are around the corner? And if they do arrive as Trump said, will they immediately turn the tide against the pandemic? Let us know what you think. Share your thoughts in the comment section below.