University of Michigan epidemiologist: All FDA hearings on COVID-19 vaccine will be public

Coronavirus Vaccine
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(WWJ) University of Michigan epidemiologist and internationally renowned expert on the transmission of infectious diseases, Dr. Arnold Monto, said he will take the COVID-19 vaccine when it becomes available.

He has an inside look at the process. Monto is on the Food and Drug Administration advisory board for the vaccine.

“We’re going to see all the data,” Monto said live on WWJ. “Before the vaccine gets approved, everything is going to be out in the public. The approvals are going to be very similar to how we approved vaccines in the past.”

The hearings are going to be “transparent” and on YouTube for everyone to see, according to Monto.

“So everybody is going to know what is known, what is not known about this vaccine,” he said.

Pfizer has announced its vaccine was 90% effective in early Phase 3 trial results. This is based on 94 COVID-19 infections among more than 43,000 volunteers, finding that 10% of those infections were in people who received the vaccine and 90% were in the placebo group.

Healthline reports the pharmaceutical company has to prepare several months of safety data to send to the FDA; a process that is already underway, which could be ready by the third week of November.

Pfizer may get Emergency Use Authorization as soon as mid-December, according to CBS' 60 Minutes.

Four-star General Gustave Perna, leader of Operation Warp Speed, hopes to deploy millions of doses by the end of the year.

"My goal [is] tens of millions [of vaccine doses] in December hopefully and we expand into hundreds of millions [of doses in] January, February, March," Perna told 60 Minutes.

Moderna announced it will be prepared to roll out 20 million doses of the vaccine by the end of the year, while hoping to manufacture 500 million to 1 billion doses next year.

This quick pace does not mean corners will be cut, Monto said.

“We’re going to get this right,” he told WWJ.

Both Moderna and Pfizer’s vaccines are mRNA vaccines, the first of its kind ever to be approved for human use.

Massive Science reports mRNA vaccines work by injecting genetic material from the virus, called messenger RNA, which gives the body instructions about which proteins to make.

The vaccine uses the messenger RNAs of the spiky proteins that cover the outer part of the SARS COV-2 virus. The body responds by making the spiky protein, but no other part of the virus.

The idea: once the body meets the virus in full, its immune system has already had practice dealing with it and can hopefully knock it out.

The vaccine does not contain the live virus itself.

The vaccine will have to be stored at -94 degrees Fahrenheit, a challenge Macomb and Oakland Counties are already preparing to meet.

FOX 2 reports the counties have ordered the freezers, costing $14,000 a piece and taking up about 40 cubic feet. Macomb County has ordered 2; Oakland County has put in a request for 10, according to FOX 2.

Each recipient will have to receive 2 doses, according to Pfizer.

As for side effects, researchers told NBC News that recipients may experience flu-like effects for a day or two: sore arm, muscle ache and fever.

Monto said people who are considered most vulnerable to severe complications or exposure to COVID-19 will be first in line when it comes out including: healthcare workers, the elderly, and people with pre-existing conditions.

For the Centers For Disease Control and Prevention (CDC) information on who is most vulnerable to COVID-19, click here.

“When it comes out, those who are at special risk are going to be first in line and because of their risk situation they should take the vaccine,” Monto said.

In the meantime, dozens of Michiganders are still dying per day after testing positive for the virus, according to the Michigan Department of Health and Human Services (MDHHS). The MDHHS reported 29 new deaths yesterday, in addition to 36 identified through a records review, and 7,072 new confirmed cases.

See the demographics of the Michiganders who have passed away after testing positive for COVID-19 here.

Michigan health system CEOs say they are seeing a rapid increase of hospitalizations in their facilities. The MDHHS reports at least five times as many people are hospitalized with COVID-19 statewide than six weeks ago.

Nearly 139,000 residents are considered recovered from the virus, after surviving 30 days since testing positive.

Monto and health experts concur that now is the time to double down on public measures like social distancing, wearing a mask over your nose and mask, washing hands often; and avoiding gatherings and unnecessary outings while vaccine production ramps up. More information on how to protect yourself and others here.

As for a return to normal…Monto said he’s confident that day will come.

“I think we’ll be good by spring or summer (2021).”

Featured Image Photo Credit: Getty Images