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Coronavirus US: Moderna's vaccine will NOT be ready by Election Day


Moderna won't be the company to fulfill President Donald Trump's request for a coronavirus vaccine by election day, the company's CEO said on Wednesday.

Stephane Bancel told the Financial Times that his company would not have enough data from its late-stage studies to file with the Food and Drug Administration (FDA) no earlier than November 25.

Bancel had previously said that Moderna would likely have enough data from its coronavirus vaccine trials to know whether the shot would work or not by November, but said there was a slim possibility of knowing if the shot would be by October is working.

If the company's COVID-19 vaccine is found to be at least 70 percent effective, the company plans to seek emergency approval for use in high-risk groups, Bancel said.

Moderna's vaccine candidate – mRNA-1273 – is nearing the finish line to enroll 30,000 people in a late-stage study of a novel coronavirus vaccine.

Early data from his tests on the safety of the shot for the elderly are promising so far. A report released on Monday shows that the shot triggered a strong immune response and the vast majority of volunteers aged 56 and over had mild or moderate side effects.

Moderna has expanded its production and is confident of producing 500 million cans a year and maybe even a billion.

Still, Bancel told the FT that Americans shouldn't expect Moderna's shot – even if approved early – to get the green light for the FDA to distribute to everyone in the US before spring.

The reveal is a blow to President Trump, but it could further pave the way to first place for Pfizer, whose CEO continues to examine the possibility of receiving an FDA-approved COVID-19 vaccine in the coming weeks.

Stephane Bancel told the Financial Times that his company would not have enough data to apply for FDA approval no earlier than November 25 (Image: earlier this month on CNBC)

Stephane Bancel, CEO of Moderna, said the company should have enough data from its coronavirus vaccine trials to know if the shot was more effective at preventing infection than a placebo by November (file).

Stephane Bancel, CEO of Moderna, said the company should have enough data from its coronavirus vaccine trials to know if the shot was more effective at preventing infection than a placebo by November (file).

November 25th is when we have enough safety data to put it in an Emergency Use Authorization (EUA) file that we would send to the FDA – assuming the safety data is good, i.e. a vaccine is considered safe & # 39; Bancel asid at the US Pharma and Biotech Conference of the FT.

Vaccines must demonstrate that they are at least 50 percent more effective than a placebo in order to be considered for approval.

To prove this, government officials said at least 150 COVID-19 infections must be registered among study participants, with at least twice as many occurring in the placebo group.

But FDA regulators could raise those standards, anonymous sources told the New York Times earlier this month.

Proposed new guidelines may require studies that drug manufacturers follow to follow volunteers for at least two months after the second dose of vaccine. That change alone would make it nearly impossible for any of the competing shooters to get a vaccine approved before November 3rd.

The reveal is a blow to President Trump, but it could further pave the way to first place for Pfizer, whose CEO continues to examine the possibility of receiving an FDA-approved COVID-19 vaccine in the coming weeks.

Tensions are mounting between Trump health officials and the White House. Trump alleged that if the FDA did so, he could override such a change in law – although it is unclear whether he has the authority to do so.

FDA Commissioner Dr. Stephen Hahn (himself a Trump appointee) said at the same FT conference that his agency plans to use these higher standards as a benchmark for approving a coronavirus vaccine.

However, the alleged new requirements have not yet seen the light of day or have been officially approved by regulators.

If a vaccine is particularly effective, companies could get their response sooner.

An independent security agency will take a first look at Moderna's data as soon as a total of 53 people in the study are infected with COVID-19.

Bancel had previously warned that a decline in infection rates in the US could delay the progress of the Moderna vaccine study.

"If the infection rate in the country slows in the next few weeks, it could be postponed. I think the worst scenario is December," he said in a recent interview with Squawk Box.

"We need people who get sick to calculate … how many people will get the disease with a vaccine and how many will get the disease on placebo to calculate effectiveness."

If most of the people who got sick got the placebo shot, it would indicate that the vaccine protects the vaccinated and could be enough evidence to apply for US approval for an EEA.

Moderna's shares rose roughly four percent after the company released the details of its late-stage coronavirus vaccine study and CEO Stephane Bancel earlier this month

Moderna's shares rose roughly four percent after the company released the details of its late-stage coronavirus vaccine study and CEO Stephane Bancel earlier this month

"If the interim report is rated positive by the independent safety committee with an effectiveness of 70, 80 or 90 percent, we will indeed be considering approval," said Bancel in a telephone interview.

"With such a level of effectiveness, when we get there we can protect many of the highest risk lives, so we will consider applying for an EEA for a very limited population," said Bancel.

He said the FDA will determine whether the vaccine's benefits for a small group of high-risk individuals outweigh the risk of not fully reading the safety data of all 30,000 study participants.

The company has already recruited 25,296 of its 30,000 planned participants. And 10,000 of those enrolled have already received both doses of the vaccine.

The two groups of high-risk people who could fall into such an EEA would be healthcare workers and the elderly, Bancel said.

Moderna released its study protocol earlier this month, which published details of how the vaccine was evaluated. If the vaccine does not reach the mark of effectiveness after 53 cases, the data security and monitoring panel will re-examine the data after 106 cases and finally check whether 151 people in the study are infected with the virus.

Public health officials have stated that in a small number of cases, approving a vaccine for widespread use would not provide enough safety information to demonstrate the vaccine's performance.

Moderna, which has never marketed a vaccine, has received nearly $ 1 billion from the US government through its Operation Warp Speed ​​program. It also has a $ 1.5 billion supply deal with the United States.

In a presentation to investors on Tuesday, Pfizer Inc announced that the company has enrolled more than 29,000 people in its 44,000 voluntary study to test an experimental COVID-19 vaccine that the company is developing with German partner BioNTech.

Pfizer expects enough data to show whether the vaccine is working by the end of October.

Last month, the CDC sent state instructions to prepare for the arrival of coronavirus vaccines by the end of October.

That schedule was repeated yesterday when the agency and its White House and Defense Department partners released a plan to start distributing free vaccines to all Americans starting January.

CDC Director Robert Redfield said the "game plan" was designed to ensure the state is ready to distribute vaccines as quickly as possible whenever they could be approved, but that the general public is unlikely to see up vaccinated in spring or summer 2021.

US officials plan to ship the first doses within 24 hours of receiving approval for an emergency or for a vaccine to be approved by the FDA.

Trump's youngest advisor on coronavirus, Dr. Scott Atlas said Wednesday the US would receive 700 million doses by March.

White House chief of staff Mark Meadows said the US will have 100 million doses of coronavirus vaccine by the end of October and 300 million doses by January.

Multiple company vaccines are being distributed to Americans under the federal government's new plans.

Moderna's shot will likely be one of them, but it seems increasingly unlikely that it will be the first.

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