As vaccines await federal approval, North Carolina finalizes its distribution plan

As daily cases reach record highs nationwide, a COVID-19 vaccine has yet to be authorized for use by the U.S. Food and Drug Administration. However, both pharmaceutical giant Pfizer and biotech company Moderna filed for Emergency Use Authorizations with the FDA last month. 

Here's what we know about the leading vaccine candidates. 

When will the vaccine be available?

In a Dec. 3 press briefing, N.C. Department of Health and Human Services Secretary Mandy Cohen said if a vaccine is authorized for use in December, the state expects to receive doses possibly as early as mid-December. However, as per North Carolina’s COVID-19 vaccine distribution plan, those vaccines will first be reserved for health care workers. Next, the vaccine will go to people with a high risk of exposure, including residents in congregate living facilities (homeless shelters, prisons, migrant farm camps) and anyone with medical conditions that put them at a higher risk for contracting COVID-19.

Due to the limited number of doses available, the majority of the population will likely not be vaccinated for several months.

“It's not a quick fix,” Cohen said at the briefing. “It will take several months to have enough supplies that anyone can readily get a vaccine. Until most people are vaccinated, the three W's remain our best tool to protect our loved ones, to make sure our hospitals are there for those who need them and to save lives.”

Additionally, it is expected the initial doses will be packaged in units of 1,000 doses due to ultra-cold storage requirements, so not all hospitals in the state will have immediate access to the vaccine.

Cohen said the packages can't be broken down into smaller units to be distributed to more hospitals because they have to be kept at a specific temperature. 

“Which is why when we get 85,000 doses, it can only go to so many hospitals," she said. "It can't even get to the more than 100 hospitals we have here in our state because, again, they package it 1,000 together, and we certainly don't want to be wasting any vaccine.”

Neither company could be reached for comment.

Where will the vaccine be available?

While some counties in North Carolina already have vaccine distribution sites lined up, Orange County Community Relations Director Todd McGee said the county is still in the process of figuring out distribution sites.

“We don't know if it's going to go through pharmacies or hospitals or providers,” McGee said. “That's just one of the things that we're still trying to get worked out, what's going to be the best, most efficient way to get it to the people who are supposed to get it first."

How many doses of the vaccines will be available?

According to press releases, Moderna is expecting to have 20 million doses of its vaccine available for use by the end of 2020, and it expects to manufacture between 500 million and one billion doses globally by the end of 2021. Pfizer is expecting to manufacture 50 million doses of its vaccine globally by the end of 2020 and 1.3 billion doses by the end of 2021.

On Dec. 3, Cohen said if Pfizer’s vaccine is approved in December, the state expects to receive an initial shipment of 85,000 doses, with weekly shipments continuing after that. Cohen said the state expects shipments from Moderna to begin the week after shipments from Pfizer if both vaccines are approved.

"At that point, we anticipate being able to both send to more hospitals, as well as start to do the vaccinations, in our long-term care settings," Cohen said. "We don't have exact numbers of how much vaccine we will have in week two and beyond yet, but we are learning more every day and trying to get that information.”

Are the vaccines safe?

Yes. According to Pfizer and Moderna, the vast majority of participants in both studies experienced very few adverse effects. 

The most common side effects of Pfizer’s vaccine were:

• Fatigue (3.8 percent).
• Headache (2 percent).

The most common side effects of Moderna’s vaccine were:

• Injection site pain (2.7 percent) after the first dose.
• Fatigue (9.7 percent) after the second dose.
• Muscle pain (8.9 percent) after the second dose.
• Joint pain (5.2 percent) after the second dose.
• Headache (4.5 percent) after the second dose.
• Pain (4.1 percent) after the second dose.
• Redness at the injection site (2.0 percent) after the second dose.

How well do the vaccines work?

In their phase three clinical trial, which enrolled over 30,000 participants, Moderna found its vaccine to be 94.1 percent effective in preventing COVID-19 cases based on a total of 196 positive cases during the study, 185 of which were in participants who received a placebo.

In Pfizer’s phase three clinical trial, which enrolled over 43,000 participants, their vaccine was found to be 95 percent effective based on a total of 170 positive cases, with 162 being participants who received placebos.

How much will the vaccines cost?

Gov. Roy Cooper said in a press conference on Dec. 1 that COVID-19 vaccines will be free for everyone in N.C., regardless of whether or not they have insurance.

@DRichman27

@DTHCityState | city@dailytarheel.com