2:00 pm
Thursday 01 October 2020
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Books – Sayed Metwally
In light of the raging struggle towards eliminating the emerging corona virus, the world received an unexpected shock about vaccines, and specifically when one of the prominent candidate vaccines would be produced.
This came after our CEO, Stephan Bansel, confirmed that the company would not be able to produce a vaccine against the Corona virus by the beginning of November as was specified.
Bancel said his company will not have enough data from its recent trials to provide it to the FDA until November 25, at the earliest.
Bancel had previously said that Moderna will likely have enough data from coronavirus vaccine trials to see if the vaccine works or not by November.
If the company’s coronavirus vaccine proves to be at least 70 percent effective, the company plans to obtain emergency permission for use in high-risk groups, Bansel said.
Moderna’s candidate vaccine – mRNA-1273 – is nearing the production line as it seeks to enroll 30,000 individuals in a final clinical phase of a novel coronavirus vaccine trial.
Early data from its tests of the vaccine safety for the elderly are promising so far, with a report showing that the dose elicited a strong immune response and left the vast majority of volunteers 56 years of age or older with only mild or moderate side effects.
Moderna has expanded its manufacturing range and is confident of its ability to produce 500 million doses per year, possibly up to 1 billion doses.
However, Bansel told the Financial Times, Americans should not expect that the Moderna vaccine – even if approved early – would get the FDA green light to distribute it to everyone in the United States before spring.
The revelation is a blow to President Trump, but it could pave the way for Pfizer to hijack the number one place in the vaccine struggle, whose CEO continues to raise the prospect of getting an FDA-approved Covid-19 vaccine in weeks. Coming.
Pfizer expects to have enough data to show whether the vaccine is working by the end of October.
The President of our Moderna added: “November 25 is the time when we will have enough safety data to be able to put it in the emergency use license file that we will send to the US Food and Drug Administration on the assumption that the safety data is good, meaning the vaccine is considered safe, and vaccines must prove that they are more effective With at least 50 percent of the placebo until it’s accepted. “
To prove this, government officials said, at least 150 cases of Covid-19 must be recorded among trial participants with at least impairment among the placebo group.
The proposed new guidelines may require trials to follow drug companies to follow experimental volunteers for at least two months after they are given their second dose of vaccines, this change alone would make it nearly impossible for any of the competing vaccine makers to get an approved vaccine before November 3.
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