What is the approval status of the Moderna and Pfizer vaccines?
Two firms have applied for emergency use authorisation from the FDA and Trump's Operation Warp Speed chief, General Gustave Perna, predicts that distribution of the vaccines will begin before the end of 2020.
There has been fresh hope in the fight against the coronavirus in recent weeks as a number of pharmaceutical companies have reported impressive results in clinical trials. Pfizer was the first to do so in early November, and Moderna have recently joined them in applying for emergency use authorisation (EUA) in the US.
The positive news comes at a vital time as the infection rate and death rate continues to rise across the States. November saw more positive tests than any month to date, while the total number of covid-19 patients in American hospitals rose to a record high of 93,238 on Monday 30 November. With those numbers expected to rise in the coming weeks as a result of Thanksgiving travel, health officials are eager to get vaccines approved and distributed as quickly as possible.
Moderna is ready to apply for emergency use authorization with the FDA for its COVID-19 vaccine. If approved, Moderna expects to create approx 20M doses by the end of 2020 and will produce between 500M to 1B before the end of 2021. pic.twitter.com/hIlUyMOcFK— NowThis (@nowthisnews) December 1, 2020
When will the Pfizer vaccine be approved?
The first major pharmaceutical break-through came when Pfizer announced that their vaccination was safe and 95% effective at preventing individuals contracting the virus. Although the vaccine showed no major negative side effects in their extensive trials they still had to apply for emergency FDA approval before it can be distributed nationwide, which they did on 20 November.
White House chief of staff Mark Meadows is scheduled to meet with FDA Commissioner Stephen Hahn on Tuesday, as President Trump has privately demanded to know why the agency hasn't granted emergency use for Pfizer's coronavirus vaccine yet, two sources say. https://t.co/JgF56f1woj— CNN (@CNN) December 1, 2020
Although this is an expedited procedure it still takes weeks for the FDA to grant approval, with a decision expected fairly soon according to Dr Onyema Ogbuagu, an associate professor of medicine at Yale School of Medicine.
“The first company and vaccine that’s ahead of the pack is the Pfizer vaccine and the FDA will sit on it December 10,” said Dr Ogbuagu. “The hope is that if there is approval it will be mid-December.”
How long before the Moderna vaccine is approved?
Hot of the heels of Pfizer are Moderna, whose results from a large study show that their coronavirus is around 94% effective. Their trials involved 30,000 volunteers, half of whom received the vaccine and half got a placebo. During the course of their study, 185 participants in the placebo group fell ill with covid-19, compared to just 11 who received the vaccine.
That news was announced on Monday as the pharmaceutical company confirmed that they too have applied to the FDA to receive emergency use authorisation for their vaccine. Their hearing will take place on the 17 December, with plans already in place for the vaccine to begin distribution before the end of the year. In a recent interview, Moderna chief executive Stéphane Bancel revealed that the firm is “on track” to have produced 20 million doses of the vaccine by the end of December.
When will the coronavirus vaccines be available?
While the pharmaceutical companies have been working on the medical side, government officials have been putting plans in place to ensure that the vaccines can be rolled out immediately once the approval is granted. President Trump’s Operation Warp Speed team, led by General Gustave Perna, have been preparing the national effort.
Just last week Perna told ABS news that he is confident that vaccines will be “on the street” and dispatched to those in need within 24 hours of receiving approval from the FDA. According to Perna, the first batch is expected to see around three million key healthcare workers and people in vulnerable groups vaccinated:
"3 million we'll send out, the other 3 million we'll send out 21 days later because we want to make sure the second dose is available for everybody."
The President shares his optimism and Trump has pledged to have vaccine distribution begin in the first half of December. He told reporters at his Thanksgiving address on 27 November that vaccine delivery will “start next week and the week after”.
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