COVID Vaccine: Safety, Distribution & Frequently Asked Questions
12 Minutes
Team Curative
Jan 10, 2021
Among all of the difficult circumstances that the coronavirus pandemic has brought about, the development of a COVID-19 vaccine with 95% effectiveness is historic—a true victory of modern medicine. While the development, study, and approval of a COVID-19 vaccine was achieved in record time, it is only the first step toward the end of the pandemic. Many logistics remain, including distribution of the vaccine nationwide to healthcare workers, at-risk individuals, and eventually the general public. In this blog post, we provide a COVID-19 vaccine update, including the current status of the COVID-19 vaccine, its distribution plan, safety concerns, and other frequently asked questions.
How Close Are We to a COVID Vaccine?
Currently, the Food and Drug Administration (FDA) has granted two vaccines emergency use authorization: the Pfizer-BioNTech vaccine and the Moderna vaccine.
Pfizer’s vaccine shows 95% efficacy (or effectiveness) at preventing symptomatic COVID-19 infection, starting seven days after the second dose is administered. Moderna’s vaccine shows 94.1% efficacy, measured 14 days after the second dose. Both vaccines appear to be, for the most part, equally protective across age, racial, and ethnic groups.
Both vaccines require two shots: a priming dose, followed by a booster shot. The interval between the Moderna doses is 28 days; the interval between the Pfizer doses is 21 days.
Both vaccines also require transportation and storage in cold environments, adding a unique challenge for the rapid distribution of the vaccines. Moderna’s vaccine must be shipped at -4 degrees Fahrenheit, about the temperature of a regular refrigerator freezer. However, Pfizer’s vaccine must be shipped and stored at -94 degrees Fahrenheit, which requires special ultra-cold freezers that must be covered with dry ice every five days. Unfortunately, this isn’t something that doctor offices or pharmacies typically contain. Additionally, after thawing, the Pfizer vaccine must be used within five days, while the Moderna vaccine is stable at a refrigerator temperature for 30 days, or at room temperature for 12 hours.
When Will the COVID Vaccine Be Distributed?
The distribution of the COVID-19 vaccine is logistically challenging, since it requires sensitive, ultra-cold transportation equipment. The Pfizer vaccine must ship in special boxes that can’t be opened more than twice a day, and as mentioned, the vaccine needs to be at around -94 degrees Fahrenheit to maintain its efficacy. According to Pfizer, over the week of December 14, 2020, around 2.9 million doses of the COVID-19 vaccine were shipped for distribution to all 50 states.
What Clinical Testing Has the COVID-19 Vaccine Undergone?
Normally, vaccines take years of research and testing before being distributed. However, due to the severity of the COVID-19 pandemic, scientists have accelerated the process to achieve a safe and effective COVID-19 vaccine. You may be wondering: is the COVID-19 vaccine safe? Rest assured that the development of the COVID-19 vaccine has included the following stages, as are standard with all vaccine development.
Preclinical Testing: The first step for vaccine development is testing the new vaccine on cells in a laboratory to determine if the vaccine can successfully provoke an immune response. After this, the new vaccine is administered to animals such as mice or monkeys to learn about the immune response and how it may be similar to that of humans.
Phase 1 Safety Trials: In this stage, safety and dosage in people are measured. The vaccine is given to a small number of people to confirm safety, dosage, and immune system stimulation.
Phase 2 Expanded Trials: After trying the vaccine in a small number of people, scientists then expand the trial to a large number of people. They also split the vaccine among different groups of people, such as children and the elderly, to learn if the vaccine performs distinctively in them.
Phase 3 Efficacy Trials: In this stage, scientists compare the results of the vaccine versus placebo in thousands of people. Scientists then measure the efficacy rate and possible side effects.
Early or Limited Approval: In this stage, emergency authorization is given based on preliminary evidence around safety and effectiveness. Some countries, such as China and Russia, have authorized the use of vaccines without having Phase 3 trial results.
Approval: Complete trial results and manufacturing plans are reviewed by vaccine regulators. In this stage, approval is given to the vaccines that meet requirements.
Additional Stages:
Combined Phases: Some vaccines have combined Phase 1 and 2 trials to accelerate vaccine development.
Paused or Abandoned: If any irregularities or worrying symptoms are observed, the trial should be paused, and should be resumed or abandoned after a deep investigation is made.
What Is the Status of COVID-19 Vaccines?
Currently, 63 COVID-19 vaccines are in Phase 1 and 2, being tested in human clinical trials. Eighteen vaccines are now in Phase 3, the final stage of testing. Five vaccines are in the early- or limited-use state. Two vaccines have been fully authorized for use and one vaccine has been abandoned after trials. Additionally, about 85 vaccines are in the pre-clinical state, being actively investigated on animals.
COVID-19 Vaccine Rollout Plan
Most Americans have been asking for several months, “When will a vaccine be ready?” Finally, all across the U.S., the first authorized vaccines are arriving at hospitals and healthcare facilities across the U.S. The Centers for Disease Control and Prevention (CDC) have set the following guidelines around vaccine allocation and who gets the vaccine first.
Health care workers and people in long-term care facilities: Starting this month, nearly 21 million health care personnel and 3 million people living in long-term care facilities (mainly elderly) will start receiving the vaccine. Initially, there won’t be enough vaccine doses for all health care workers; therefor
e, states will prioritize based on exposure risk, starting with emergency room staff and the oldest personnel.
Essential workers: Beginning early 2021, essential workers will be the second ones to receive the COVID-19 vaccine. This includes about 87 million Americans that work in education, transportation, manufacturing, food and agriculture, law enforcement, and emergency response, among other sectors.
People over 65 years old and adults with underlying medical conditions: Some states can decide to distribute the vaccine to people over 75 years of age before some essential workers. Public health officials hope to vaccinate elderly adults during the first quarter of 2021.
All other adults: According to Dr. Anthony Fauci, MD, the leading expert in infectious disease and the director of the National Institute of Allergy and Infectious Diseases, adults in the general population may start getting vaccinated in April 2021. However, based on vaccine availability and distribution speed, many adults shouldn’t expect to get the vaccine until May or June 2021.
Under 16 years old: As of today, the vaccine hasn’t been approved in children. Experts believe that those under 16 years of age might start to get the vaccine in several months or even a year.
Frequently Asked Questions About the COVID-19 Vaccine
Below are some additional questions we receive about the COVID-19 vaccine.
How Many Shots of COVID-19 Vaccine Are Needed?
Only one of the COVID-19 vaccines that is currently in Phase 3 of clinical trials requires one shot to be effective. All of the other vaccines require two shots for effectiveness, including the two vaccines that have been approved for use.
Are You Able to Choose Which Vaccine You Receive?
The vaccine you receive depends on many factors, such as the available supply in your area at the time you get the vaccine, and whether some vaccines are more effective in certain populations, such as the elderly. The Pfizer and Moderna vaccines are both now available.
Is the Vaccine Free for All Americans?
Currently, you shouldn’t have to pay an out-of-pocket expense to get the COVID-19 vaccine, though the health care personnel who will administer the vaccine could ask for your insurance information. If you don’t have insurance, you should still be allowed to get the vaccine at no cost to you. This spring, Congress passed legislation which prohibits insurers from charging any cost sharing, like a deductible or a co-payment, for COVID-19 vaccines or COVID-19 testing. Additionally, this legislation prohibits doctors, hospitals, and pharmacies from charging patients who get vaccinated, including those without insurance.
Health experts recommend that if you get vaccinated in an urgent care clinic or at a doctor’s office, you should still speak with them about possible hidden charges, so you won’t be surprised with any additional bills.
How Long Until the COVID-19 Vaccine Protects You From the Virus?
Based on clinical trial data, those who receive the first shot of the Pfizer vaccine won’t be fully protected until roughly a week after they receive the second shot. According to the FDA and New England Journal of Medicine, research shows that the vaccine’s protection began about 10 days after people received the first dose, but only with a 52% efficacy. A 95% of efficacy was reached one week after the second shot was administered.
What Are the Possible Side Effects of the COVID-19 Vaccine?
You may be wondering: is the COVID-19 vaccine safe? Pfizer officials say there were no cases of serious allergic reactions in the clinical trial involving nearly 44,000 participants.
On December 13, 2020, the CDC said that people who have had severe reactions to vaccines or injectable drugs can still get the Pfizer vaccine for COVID-19, but they should discuss the risks with their doctors and be monitored for 30 minutes after getting the shot.
According to the FDA, the main possible side effects include pain where you get the shot, fatigue, headache, chills, fever, and joint and muscle pain. However, these symptoms are all described as temporary and minimal compared to a real infection. They are not a sign that the vaccine is unsafe, but that one’s immune system is kicking into gear to produce antibodies against the virus. The injection itself is administered into the arm and shouldn’t feel different from other vaccines.
Should I Be Concerned About the COVID-19 Vaccine if I Have Allergies?
Health experts recommend that those who have a history of severe allergies and have experienced anaphylaxis to speak with their primary care doctor about vaccine safety and potential precautions they should take.
Even though serious reactions to the vaccines are unusual, in Britain, two health care workers reported anaphylaxis after getting the vaccine on the first day it was available. Both were treated and recovered, and both had a history of severe reactions. Due to this event, the British authorities recommended that people who have had an anaphylactic reaction shouldn’t receive the vaccine yet. The U.S. health experts have mentioned that severe reactions such as those experienced by the British health care workers can be treated and prevented with medicine. The FDA required Pfizer to increase monitoring to detect any cases of anaphylaxis and submit any data found.
With other types of vaccines administered each year in the U.S., less than one in a million patients have reported an anaphylactic reaction. According to an FDA publication, only one of the 18,801 participants who received the vaccine in Pfizer’s late-stage clinical trial had an anaphylactic reaction.2
To Achieve Herd Immunity, What Percentage of the Population Needs the COVID-19 Vaccine?
Herd immunity, also known as population immunity, means that enough of a population has either been exposed to, or vaccinated for a disease that a virus or bacteria is unlikely to spread due to the generation of antibodies among the population. The percentage of people that need to be vaccinated to achieve herd immunity varies by disease. According to the CDC, health experts have not yet determined which percentage of the population needs to get the vaccine to achieve herd immunity to COVID-19.
Do I Need to Be Vaccinated if I Tested Positive For COVID-19?
Experts believe that getting the vaccine is not only safe, but also beneficial for those who have had COVID-19 previously, since it is unknown how long immunity lasts after being infected with the virus. The protection or immunity gained from being infected varies from person to person and depends on the disease. For COVID-19, some evidence suggests that immunity against reinfection may only last a few months as the virus can mutate and then reinfect individuals. There isn’t enough data to determine exactly how long the vaccine protection lasts, so a vaccine and testing is the best way to stop the spread.
Do I Still Need to Wear a Mask After Getting the COVID-19 Vaccine?
The answer is yes, but fortunately not forever. The vaccine clinical trials determined that those who receive the vaccination have protection against the current strain of the virus. However, because the virus mutates frequently, as with the flu virus, it’s unclear whether or not future vaccination will be necessary to protect against other strains of the virus. Using research on the flu vaccine as a reference, investigators hope that vaccinated people won’t be able to spread the virus, however more evidence is needed. In the meantime, vaccinated and unvaccinated people should keep using face coverings as well as maintaining hygienic practices to avoid unknowingly spreading the virus to others.
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The beginning of the vaccine distribution has been a silver lining for all Americans in one of the pandemic’s darkest points. Many states have been facing never-before-seen COVID-19 cases and deaths, with more than 320,000 deaths in the U.S. as of December 2020. While it’s tempting to let your guard down, it’s important for U.S. citizens to work together to prevent the spread of the virus through robust testing and vaccination. Schedule a fast, easy, non-invasive COVID-19 test today to stay safe and help stop the spread as you await vaccine distribution.
Curative Inc. and its subsidiary, Curative Management Services LLC, engage with medical entities that provide vaccination services.
