None of the information provided is medical advice, and individuals should consult their providers with medical questions.
About the vaccine
Who is making the vaccines?
Multiple vaccines are in development, but none have been approved for use in the United States. Two manufacturers — Moderna and Pfizer — filed applications with the Food and Drug Administration to permit the companies to move forward with distribution of the vaccines to the states.
What is an Emergency Use Authorization and who decides it?
Federal law permits the FDA commissioner to allow unapproved medical products to be used in emergencies where there are “no adequate, approved and available alternatives.” Because the pandemic is a global emergency, the FDA considers authorizations for COVID-19 vaccines.
Pfizer submitted an application for Emergency Use Authorization in November. On Dec. 10, an FDA panel considered the application and voted in favor of the application.
Moderna submitted an application to be considered at a Dec. 17 meeting of the FDA panel.
What happens after the Emergency Use Authorization?
After an Emergency Use Authorization is granted, another body at the Centers for Disease Control and Prevention (the Advisory Committee on Immunization), will consider whether the vaccines should be used for particular populations. The CDC committee voted in an emergency hearing on December 12 to recommend the vaccine for Americans 16 years-old or older, and CDC director Robert Redfield signed the recommendations.
How effective are the vaccines?
Pfizer’s vaccine provides 95% efficacy against COVID-19 at the one-week mark after the second dose, the company reported to the FDA.
What do we know about the safety of the proposed vaccines?
An independent data monitoring committee found Pfizer’s drug met its safety requirements during the trial of more than 43,000 participants. Reactions were “mostly mild to moderate, and with less frequency and severity in adults >55 yrs than in younger adults,” according to the data Pfizer submitted. “There were no other specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities or prior SARS-CoV-2 infection.”
Moderna will also present safety data when the FDA considers its application. The manufacturers are continuing to follow trial patients for longer-term safety concerns.
Is there a difference between the Moderna vaccine and the Pfizer vaccine?
Both vaccines are mRNA vaccines, or messenger RNA vaccines, which “teach our cells how to make a protein — or even just a piece of a protein — that triggers an immune response inside our bodies,” a CDC resource explains.
“That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies.”
Both vaccines require two doses. The Pfizer vaccine requires 21 days in between the first and second doses while the Moderna vaccine requires 28 days between doses.
But in terms of efficacy, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN, “since these vaccines are almost identical, I don’t think it makes any difference,” he said. “They’re both mRNA vaccines. They both have 94% to 95% efficacy, and they both have almost 100% efficacy against serious disease.”
The initial distribution in North Carolina will be of the Pfizer vaccine, with Moderna expected to be supplied if it is given Emergency Use Authorization.
The Pfizer vaccine requires storage in ultracold freezers at minus 70 degrees Celsius while the Moderna vaccine requires standard freezer storage.
Do providers have enough of the other supplies required for immunizations (needles, gloves, etc.)?
Though some states are experiencing shortages of some supplies, North Carolina has ample supplies, N.C. Department of Health and Human Services Secretary Dr. Mandy Cohen said.
Getting the vaccine
Who will get the first vaccinations in North Carolina?
Health care workers and first responders who are at high risk of interaction with COVID-19-positive patients will be the first population to receive the vaccine. The supply will be limited initially, and officials expect the first shipment to include only 85,800 doses.
Eleven hospitals with ultracold storage capacities will receive the first doses.
|Caldwell Memorial Hospital||Duke University Hospital|
|Cape Fear Valley Health System||CMC Enterprise|
|Hoke Hospital||UNC Medical Center|
|Bladen County Hospital||Wake Forest Baptist Medical Center|
|CarolinaEast Medical Center||Catawba Valley Medical Center|
|Margaret R Pardee Memorial Hospital
(Henderson County Hospital Corporation)
Who is next in line?
Forty-two additional hospitals will receive the second round of doses for vaccination of health care workers.
The second week of distribution will include long-term care staff and residents, Cohen said. The distribution to long-term facilities comes from the state’s allocation of vaccines, but the distribution is managed by the federal government through a partnership with CVS and Walgreens. The retail pharmacies will operate vaccination clinics at long-term care facilities throughout the state.
After health care staff and long-term care residents and staff, the distribution will move to people who have two or more of the chronic conditions, as defined by the CDC, that increase risk of disease severity.
In addition to people with two chronic conditions, the next distribution will include people over 65 who live in congregate settings such as migrant farm camps, prisons/jails, homeless shelters) and staff in those settings.
If I am not in one of those early priority groups, when will I get a vaccine?
Distribution in North Carolina depends on supply. After the previously outlined groups, the next distribution is expected to follow the NC Vaccine Plan:
- People under the age of 65 with one or no chronic conditions who live in congregate living settings (migrant farm camps, prison/jails, homeless shelters).
- Front-line workers at high or moderate risk of exposure who have one or no chronic conditions.
- Health care workers not included in earlier phases.
- Adults with one chronic condition (as defined by the CDC).
- Individuals 65 or older with one or no chronic conditions.
The last phase of distribution before it is open to all remaining individuals includes “remaining front-line workers and workers in industries critical to societal functioning who are at higher risk of exposure and who have not been vaccinated in previous phases.” This phase may also include K-12 and college students if the safety data is sufficient for use by those younger than 16.
Where will the vaccine be available in North Carolina?
As the state receives more shipments of vaccines, it will become available at more providers. After the initial distribution to specific hospitals, the Department of Health and Human Services expects to send doses to local health departments, private providers and community clinics.
What are the side effects?
“The most common solicited adverse reactions were injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%); severe adverse reactions occurred in 0.0% to 4.6% of participants,” according to information Pfizer submitted to the FDA.
Because individuals may experience mild or moderate side effects, some hospitals are staggering vaccine distribution for health care workers to avoid staff shortages. “We don’t want everyone to feel crummy all at the same time and have to call out and then folks have staffing challenges,” Cohen said.
What is the recommendation for people who have already had COVID-19?
The N.C. Department of Health and Human Services does not yet have enough information to advise individuals who have already contracted coronavirus.
“We don’t know enough to say if having had COVID-19 creates natural immunity or how long that may last. Early data suggests that natural immunity from COVID-19 may not last very long, but more studies are needed to better understand,” a department statement said.
A small number of Pfizer trial participants had prior evidence of infection before the vaccine. Their safety data in the trial looks “basically the same” as the noninfected participants, Dr. William Gruber, senior vice president of vaccine clinical research and development for Pfizer, told the FDA panel. “Clearly, these individuals did not fare worse from the vaccine.”
Is there any immunity after the first dose? How long after getting the second dose will I develop immunity?
The science is not certain, but there appears to be some immunity after the first dose of the Pfizer vaccine. “A trend of potential efficacy following a single dose is observed in the data, however, a conclusion is limited because almost all participants received a second dose,” Pfizer reported to the FDA.
Nonetheless, officials strongly recommend getting the second dose for maximum effect.“You get optimal immunity anywhere from seven to 10 days after the second dose,” Fauci told CNN.
How many doses will I have to get? Will I get a reminder if I need a second dose?
The initial phases of distribution are expected to include vaccines from Pfizer and Moderna, which both require two doses. Providers in North Carolina will record contact data at the first dose so they can remind individuals to get the second dose.
Another vaccine in development from Johnson & Johnson’s Janssen Pharmaceuticals requires only one dose. The Janssen vaccine is not an mRNA vaccine and does not require ultracold storage.
Must someone be a citizen to receive the vaccine?
No. All residents are eligible for the vaccine.
How much will the vaccine cost in North Carolina?
There is no cost for the vaccine in North Carolina.
Should children get the COVID-19 vaccine?
The Emergency Use Authorization for Pfizer’s vaccine was for individuals 16 years old or older. Pfizer is studying the vaccine in 12- to 15-year-olds, but no vaccine is yet authorized for children.
After the vaccine:
Can you still be a carrier and transmit the virus if you have had the vaccine?
The short answer is the scientists do not know yet if people can transmit the virus even if they have been vaccinated.
Even if it doesn’t completely prevent you from transmitting to another person, it may lessen the likelihood. “If it doesn’t protect you against infection, it’s likely that the degree of immunity that you have is going to diminish the level of virus in your nasal pharynx. And even though you might be infected, it is likely not proven yet, but likely that it would be very less likely that you are going to transmit it,” Fauci told CNN.
How long does immunity last? Will I have to get a vaccination annually?
Scientists do not yet know the duration of the vaccine. It is possible that repeat doses may be needed.
If I get a vaccine, do officials think I still need to wear a mask?
Yes. Because it will take some time for herd immunity to be reached and because viral spread continues to be rampant in North Carolina, people should continue to wear masks, Cohen said.
Where will adverse responses be reported?
The CDC and FDA run a system whereby individuals can report adverse effects, the Vaccinate Adverse Events Reporting System, or VAERS. Health care providers are required to report certain events, but anyone who experiences an adverse reaction may submit their information to the system. The CDC and FDA use the information to assess any patterns in reaction as well as any particular clusters of adverse events.
Editor’s note: This article was initially posted at 4 p.m. on Dec. 11 but has been updated several times, most recently on Dec 13.