The day has finally come. A COVID-19 vaccine has been approved and is currently being distributed.
But there are still a lot of questions surrounding the vaccine, like will another distributor enter the market? Will the U.S. run out of the vaccine? Who can get the COVID-19 vaccination and many more. In this post, we will answer those questions and many more.
One vaccine that was developed by Pfizer-BioNTech has received FDA Emergency Use Authorization and is currently being distributed. A second vaccine developed by Moderna has been recommended for emergency use by an FDA panel.
Moderna's and Pfizer-BioNTech's Covid-19 vaccines have shown similar efficacy levels of near 95%. Moderna developed its vaccine in collaboration with National Institutes of Health scientists.
The covid-19 vaccine is in short supply. The initial batches are being given to high priority groups of people who are at high risk of infection or serious illness, including frontline health care workers and long-term care facility residents.
The Moderna vaccine can be distributed more widely because medical professionals can store it at normal freezer temperatures and, unlike the Pfizer vaccine, it does not require ultra-cold storage. Moderna's vaccine also comes in much smaller batches, making it easier for hospitals in less populated areas to use fast.
A decision on the "third priority" vaccination group is coming shortly.
Healthy adults who are 65 and younger and kids will likely have to wait until spring or even summer to get the COVID-19 vaccine. It will depend on how many vaccines get approved, how quickly the vaccines are manufactured and distributed, among other factors.
Several groups of independent experts are weighing in on how to allocate the COVID-19 vaccine, including the National Academies of Science, Engineering and Medicine, and Johns Hopkins University.
The experts have laid out principles focusing on protecting the nation's healthcare workers and most vulnerable people as well as controlling the virus' spread and being equal across society.
Neither company reported any serious issues with allergic reactions during clinical studies. But, it's important to note that when drugs or vaccines move out of trials and into broader distribution, rare side effects can emerge.
The Modern and Pfizer vaccines are similar, but they aren't identical. Both vaccines are made up of genetic material called mRNA that's encased in a bubble of lipids.
The mRNA composition in both vaccines is not the same, so researchers can't determine if an allergic reaction from one vaccine would result in a reaction to the other. That possibility does concern researchers.
This is to be determined. COVID vaccines may become an annual vaccination, similar to the flu shot. Or, it could be that the vaccine's benefits last longer than a year. We just have to wait and see how durable the vaccine's protection is.
The Trump Administration's Operation Warp Speed is responsible for shipping the vaccine. But, ultimately, it is up to each state to decide where the doses go.
Emergency Use Authorization is when regulators allow vaccines to be administered to certain people while safety and effectiveness studies are still ongoing.
A vaccine must be reviewed by the Food and Drug Administration (FDA) before it is permitted in the United States. The FDA requires the vaccine is studied in thousands of people. Under normal circumstances, it takes about ten years to get FDA approval for a vaccine. But the federal government is using various methods to speed up the process for COVID-19 vaccines dramatically for situations like the global pandemic.
During a health crisis, the FDA may loosen its normal scientific standards to allow emergency use of experimental drugs, devices, vaccines, and other medical products.
The most commonly reported side effects that lasted for several days included:
Pain at the injection site
More people experienced these side effects after receiving their second dose of the vaccine than they did after the first dose.
The COVID-19 vaccine will not cost you anything out-of-pocket, but you will be asked to provide your health insurance information. If you are uninsured, you can still get vaccinated at no charge.
Congress passed legislation banning insurers from applying any cost-sharing to the vaccine, like requiring a co-payment or deductible. The legislation also banned pharmacists, doctors, and hospitals from billing patients for the vaccination, even the uninsured.
Pregnant and breastfeeding women are asked to consult with their doctors about whether they should receive the vaccine or not. Pfizer has not tested its vaccine in pregnant or breastfeeding women. Federal health officials have not yet issued any specific guidance, other than allowing pregnant and breastfeeding mothers to get vaccinated if they want to.
It is safe and likely beneficial for anybody who has already had COVID-19 to get the vaccine at some point. Though many people who have had COVID-19 develop immunity, it's too soon to know how long the immunity lasts.
Despite the short vaccine development timeline, the safety and efficacy of the vaccine has shown to have great results. Both Moderna and Pfizer had to submit applications to the FDA that include two months of follow-up safety data from Phase 3 clinical trials conducted by universities and other independent bodies.
Pfizer's trial had 44,000 participants, and no serious safety issues have been reported.
The Centers for Disease Control and Prevention, or the CDC, has established phases for vaccine distribution to different segments of the population. As we mentioned, at-risk healthcare workers and residents of long-term facilities are getting the vaccine now.
Phase one includes essential workers, like emergency medical technicians, and frontline workers at very high risk of infection, like food workers. This phase may also include older adults living in congregate settings or crowded conditions.
The plan also has a Phase 1c, which includes people of all ages with underlying health conditions like diabetes and kidney disease who are at a higher risk of dying or becoming severely sick from COVID-19.
Phase two would distribute the vaccine to critical risk workers— people who are high-risk of contracting COVID-19 at work, including teachers and school staff.
Phase two includes people of all ages with conditions that put them at moderately higher risk, all older adults not included in Phase 1, people in homeless shelters or group homes for people with physical or mental disabilities or in recovery; and people in prisons, jails, detention centers, and similar facilities, and the staff who work there.
It is estimated that phase one and phase two of the vaccine would cover about 45-50% of the U.S. population.
Phase three includes your adults, children, and employees in industries that are essential to society's functioning and who are at high risk of exposure who were not included in phases one or two.
Phase four would include everybody else.
Pfizer and Moderna's Covid-19 vaccines have two doses. The booster shot must be given a few weeks after the initial vaccine. Pfizer's second dose comes three weeks after the initial dose. Moderna's second dose comes four weeks after the first.
The second dose is vital because it provides a potent boost that gives people strong, long-lasting immunity.
If, for any reason, you don't get the second shot exactly three weeks after your first, you will not have to start over again with another two-dose regimen. It can actually be picked up any time after the first dose without requiring to re-do the initial dose.
Some future vaccines only require one dose. For example, Johnson & Johnson expects data in January that will show whether its experimental vaccine works after a single dose. If it does not, the company has also started a separate trial using a double dose system.
The two vaccines and an ambitious rollout by the federal government and states to deploy them are the first real glimmers of hope after the year-long pandemic is to blame for the loss of more than 300,000 American lives, the permanent closure of millions of businesses, and the separation of many families from their loved ones, especially during the height of the holidays.