Coronavirus Vaccine Progress
The FDA granted emergency use authorization to Pfizer-BioNTech's COVID-19 vaccine for people 12 through 15 years of age on May 10, 2021. The vaccine will be administered as two doses given 3 weeks apart, the same regimen given to anyone 16 or older.
However, Moderna and Johnson & Johnson, two other companies that produce COVID-19 vaccines, have FDA approval for use only for people 16 and older in the U.S.
Canada approved the same Pfizer vaccine for people 12-15 years of age on May 5, 2021. Pfizer has said that it’s working on clinical trials for coronavirus vaccines for children aged 6 months to 11 years. Their trials for ages 12-15 showed the vaccine to be 100% effective for people in that age group.
Initially, health care workers and the elderly were the first to receive the vaccine. But following the success of mass production and distribution, in mid-April, the vaccine was made available to anyone older than 16 years old.
The CDC also says the vaccine is safe for pregnant women and there is no indication it poses any danger to the fetus. There have been reports of adverse allergic reactions to the vaccine, so at present time, people who have a history of severe allergies are advised not to take it.
Both the Pfizer and Moderna vaccines have shown over 90% efficacy for adults and require two doses administered several weeks apart. Johnson & Johnson requires just one shot and is 85% effective. China and Russia have both developed their own vaccines that are being used in other countries.
The Pfizer vaccine uses messenger RNA (mRNA). This is what carries the instructions for making the “spike” protein that lets the virus enter human cells. The mRNA vaccine tells your immune cells to make the protein and act as if they’ve already been infected with the coronavirus, giving you some immunity against it.
The J & J vaccine uses DNA that’s designed to trigger an immune response to the virus.
Still another candidate uses the recombinant vesicular stomatitis virus (rVSV) which was used to create the Ebola vaccine.
Several vaccines have weakened versions of the adenovirus, one of the viruses that causes the common cold. It’s been combined with genes from the new coronavirus’ spike protein to trigger your immune system to fight it.
Yet other vaccines teach your immune system to target the coronavirus by using versions of the spike protein or the virus itself.
This version of the coronavirus only surfaced in late 2019. Normally, developing a new vaccine for a new virus takes years, but scientists were able to get a boost from research on similar coronaviruses that cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).
What Does a COVID-19 Vaccine Do?
When you come into contact with viruses or bacteria, your body’s immune system makes antibodies to fight them off.
A vaccine forces your immune system to make antibodies against a specific disease, usually with a dead or weakened form of the germs. Then, if you come into contact with them again, your immune system knows what to do. The vaccine gives you immunity, so you don’t get sick or so your illness is much milder than it otherwise would have been.
The vaccine should slow the spread of COVID-19 around the world. Fewer people should get sick, and more lives can be saved.
How Are Vaccines Developed?
The development of a vaccine against COVID-19 has taken place in an unparalleled pace. Usually such a process takes years, but the scope of the pandemic triggered round-the-clock work by thousands of researchers working on over 100 different forms of the vaccine.
Effectiveness and safety were key concerns and the Pfizer vaccine approved in the U.S. for emergency use has been found to have 95% efficacy after its second dose.
Before any vaccine can be used widely, it must go through development and testing to make sure that it’s effective against the virus or bacteria and that it doesn’t cause other problems. The stages of development generally follow this timeline:
- Exploratory stage. This is the start of lab research to find something that can treat or prevent a disease. It often lasts 2 to 4 years.
- Pre-clinical stage. Scientists use lab tests and testing in animals, such as mice or monkeys, to learn whether a vaccine might work. This stage usually lasts 1 to 2 years. Many potential vaccines don’t make it past this point. But if the tests are successful and the FDA signs off, it’s on to clinical testing.
- Clinical development. This is a three-phase process of testing in humans. Phase I usually lasts 1 to 2 years and involves fewer than 100 people. Phase II takes at least 2 years and includes several hundred people. Phase III lasts 3 or 4 years and involves thousands of people. Overall, the clinical trial process may stretch to 15 years or more. About a third of vaccines make it from phase I to final approval.
- Regulatory review and approval. Scientists with the FDA and CDC go over the data from the clinical trials and sign off.
- Manufacturing. The vaccine goes into production. The FDA inspects the factory and approves drug labels.
- Quality control. Scientists and government agencies keep tabs on the drug-making process and on people who get the vaccine. They want to make sure it keeps working safely.
How to Volunteer
If you're interested in volunteering for a COVID-19 vaccine trial, here are some sources for more information:
- COVID-19 Prevention Network (CoVPN). This is funded by the National Institute of Allergy and Infectious Diseases and coordinated by the Fred Hutchinson Cancer Research Center in Seattle. Its goal is to enroll thousands of volunteers into COVID vaccine trials nationwide. Many research centers are using this site to find volunteers.
- Clinicaltrials.gov. This is a government database of public and private clinical studies done worldwide. The site also offers considerations for joining a clinical trial.
Sites that link volunteers with trials nationwide include:
Individual hospitals, universities, research centers, and others may also provide opportunities to enroll in a COVID-19 vaccine clinical trial. Some include:
- Kaiser Permanente
- Medical University of South Carolina
- Meridian Clinical Research
- Penn Medicine
- Saint Louis University
- SAResearch (Clinical Trials of Texas)
- University of California, Davis
- University of California San Diego
- University of Maryland
- University of Rochester Medical Center
- Vanderbilt University
- Wake Research
You can also call or visit the website of your local hospital or research institution to find out if it is taking part in any trials.