The US Food and Drug Administration approved two vaccines for COVID-19. We wanted to answer some frequently asked questions about vaccines.
As 2021 begins, the coronavirus pandemic is reaching its most devastating moment yet. North Carolina is seeing its highest reports of daily new cases in January, more than four to five times what the state was experiencing in November, as well as high hospitalization numbers that are stretching the capacity of medical facilities.
But there is hope. A light at the end of the tunnel: a vaccine. While America’s response to the pandemic has been nothing short of a disaster, the scientific and medical community has worked tirelessly and is on track to develop multiple effective vaccines in record time that could bring the pandemic to an end.
In the coming weeks, the US Food and Drug Administration (FDA) could approve the first vaccines for COVID-19. With that in mind, we wanted to answer some frequently asked questions about vaccines.
Is there a COVID vaccine?
Yes. The FDA has approved two vaccines, one by Pfizer and one by Moderna, for use in the United States. Though there are limited supplies, both are being distributed in North Carolina. The vaccines require two doses, given several weeks apart, in order to be effective. Results from large-scale clinical trials found both vaccines had efficacy of 95%, meaning that they greatly reduce the risk of having serious complications from the disease. Researchers are currently working on dozens of more vaccines, with 65 vaccines in clinical trials on humans, and 20 that have reached the final stages of testing, according to a New York Times database.
Who is making the COVID vaccine?
While there are many trials underway and companies and countries continue to work away on vaccines, the two companies behind America’s approved vaccines are the pharmaceutical companies Moderna—which partnered with the National Institutes of Health—and Pfizer, which partnered with the German company BioNTech. Each company released initial data from their trials last fall showing that each of their vaccines were more than 90% effective in protecting people against coronavirus infection.
When will I be able to get the COVID-19 vaccine?
That depends on how old you are, what your job is, and whether you have any other medical conditions. Many counties and health systems across North Carolina, as of Jan. 15, began offering vaccinations to those over 65 and all health care workers as the state moves into Phase 2. The plan has changed several times since its rollout, as federal guidance changes.
North Carolina is now following this plan:
· Phase 1a: Medical and health care workers and long-term care staff and residents.
· Phase 2: Older adults over the age of 65, regardless of health condition.
· Phase 3: Frontline essential workers.
· Phase 4: Adults at high risk for exposure and increased risk of severe illness.
· Phase 5: Everyone else.
Right now, many counties and health systems in the state, who are administering their own vaccination programs with assistance from the state, are focusing on adults over the age of 65.
[That changed from those over age 75 with the Trump Administration changing its recommendations Tuesday to prioritize those over 65 in order to make sure there are no unused vaccines.]
Is the vaccine safe?
The vaccine development process is a rigorous, comprehensive process that begins with testing new vaccines on animals, such as mice or monkeys, to see if it produces an immune response.
Scientists then give the vaccine to humans in three separate phases, beginning with a small number of people in phase one in order to test safety and dosage and determine if it triggers the immune system. In phase two, scientists give the vaccine to hundreds of people across different age ranges and at different levels of health, in order to see how the vaccine behaves among different populations. In the third and final phase, tens of thousands of people receive the vaccine, and scientists compare their health outcomes with test subjects who received a placebo. This effectively shows whether the vaccine protects against COVID-19 and whether the vaccines produce any rare or dangerous side effects.
The process is thorough and the bar to clear for FDA approval is high, incentivizing companies to take a safe, conservative approach. Multiple companies, including AstraZeneca—which conducted its trials in partnership with Oxford University—and Johnson & Johnson temporarily paused their COVID vaccine trials to investigate potentially adverse side effects in one person in each trial, before ultimately resuming them after the unexpected illnesses could not be linked to the vaccines.
As part of their applications to the FDA, both Moderna and Pfizer included two months of follow-up safety data from their Phase 3 human clinical trials that were conducted by independent bodies, such as universities. By September, Pfizer had enrolled 44,000 participants in its trial without a single serious safety issue being reported.
Some participants in the trials did experience side effects, including fever, muscle aches, headaches, and fatigue after receiving the shots, but those symptoms generally did not last more than a day. Also, such reactions are usually a sign that the body’s immune response is being activated as intended.
The CDC has had some reports of people who have had significant allergic reactions to the vaccines, and is recommending that people who have had issues with prior vaccines talk with their health providers. They also suggest that people who get vaccines stay on site near medical professionals for 15 to 30 minutes after getting the shot in case there is an adverse reaction.
Who will get vaccines first?
The Centers for Disease Control and Prevention (CDC) panel voted in December to recommend giving America’s 21 million healthcare workers and 3 million long-term care facility residents the first coronavirus vaccine doses once they’re cleared for public use. North Carolina followed that recommendations when
But even with the CDC’s decision, it is up to state and local governments to form final vaccine plans and determine which individuals get vaccines first. North Carolina opted to follow the CDC recommendations closely, starting with health care workers and those in long-term care facilities before moving on to older adults in the general population.
NC DHHS also released a video—“You Have a Spot, Take Your Shot”—showcasing several older North Carolinians , including many community leaders, talking about why they opted to get vaccinated.
When will other Americans get a vaccine?
COVID-19 has been unpredictable in that there’s not a clear reason why some people who might be otherwise healthy face serious complications. But what is known is that those who are older, who often may have other health conditions, are more likely to die from the disease than younger adults.
In NC, those over 65 years old make up 15% of the total cases, but more than 80% of the deaths, according to the NC Department of Health and Human Services.
While each state will determine its own process, North Carolina has chosen to make older residents (those over 75) next in line for the vaccine, followed by first responders and essential workers working in food and agriculture, education, and transportation who are more at risk of contracting the virus because they often cannot work from home.
After those workers, seniors and vulnerable adults with pre-existing medical conditions such as obesity or heart disease that put them at high risk of infection are next in line.
These groups of individuals are likely to receive vaccines in January, February, and March, with all other adults falling in line after. Children are likely to be last in line, as the vaccines’ impact on kids under the age of 16 has not yet been conclusively studied.
Federal health officials hope that all Americans will be able to access a vaccine by June, but that timeline could change depending on how many vaccines are ultimately authorized.
What will the vaccine cost?
Nothing. The federal government has promised that vaccines will be free to all Americans.
How do I sign up for a vaccine?
If you are eligible, you can look to see if the local health care systems nearby public health departments are offering vaccines. You can find contact information for local health departments in NC here to see if there are appointments available, or call the NC DHHS’ COVID-19 Hotline at 1-877-490-6642.
Remember, vaccine supplies are still limited and there may not be available appointments, even if you are eligible.
Do MMR vaccines really protect you against COVID?
Recent research has shown that the Measles-Mumps-Rubella vaccine may offer some protection against being infected by the coronavirus and reduce the severity of symptoms among those diagnosed with COVID-19.
While there could be a relationship between the MMR vaccine and COVID, doctors still say that there’s not enough evidence to recommend adults get booster shots. Instead, they recommend that everyone get the COVID-19 vaccine rather than relying on the possibility that the MMR vaccine offers some protection.
Have Russia and China already vaccinated their citizens?
China and Russia have approved vaccines without waiting for the results of their Phase 3 trials and begun vaccinating some residents. Both countries are attempting to use their vaccines as an international bargaining chip with which to increase their economic and political standing in the world, but health experts say rushing the process poses serious risks.
The US is unlikely to rely on unproven Russian or Chinese vaccines, as those countries are primarily directing their stockpiles to countries with less robust medical infrastructures across Africa and the Middle East.
Will the vaccine be mandatory in the US?
It is unclear whether the federal government will attempt to mandate vaccinations. During the presidential campaign, President-elect Joe Biden said he was open to making a safe vaccine mandatory, depending on its effectiveness, the vaccine distribution process, and how rampant the virus was in the country. But he also admitted that it would be nearly impossible to actually implement a mandate.
“You can’t say, ‘Everyone has to do this,'” he said during an October town hall event.
The New York Times reported that President-elect Biden’s transition team is still discussing whether to try to institute a requirement, and state governments could also seek to pass vaccine mandates, though those would likely trigger legal battles.
Employers also have the right to force their workers to be vaccinated, but workers can request exemptions based on medical reasons or religious beliefs.
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