The top COVID-19 vaccine contenders, safety concerns, and health updates—all in one place.

By Melissa Mills
Updated September 17, 2020
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With more than 27.5 million coronavirus infections—including 6.6 million cases and over 196,600 deaths in the U.S.—since the start of the pandemic, the race to develop a COVID-19 vaccine is on.

Progress is being made, and at a quicker pace than usual due to the White House's Operation Warp Speed, which aims to deliver 300 million doses of a safe vaccine to stop SARS-CoV-2, the virus that causes COVID-19, to the American public by January 2021. As of September 3, the Centers for Disease Control and Prevention (CDC) told public health officials across the country to be prepared to distribute a coronavirus vaccine to health care workers, essential workers, and high-risk groups as early as November—potentially before clinical trials are complete if results are positive. However, the CDC also said that “the COVID-19 vaccine landscape is evolving and uncertain, and these scenarios may evolve as more information is available.”

On September 16, Robert Redfield, M.D., the director of the CDC, said, "If you're asking me when is it going to be generally available to the American public, so we can begin to take advantage of vaccine to get back to our regular life, I think we're probably looking at third, late second quarter, third quarter 2021." However, President Trump pushed back hours later, saying a coronavirus vaccine would be distributed quickly after being approved.

With coronavirus restrictions easing, businesses opening their doors little by little, and schools reopening as summer break comes to a close, parents are wondering when, exactly, things will go back to "normal"—and what a vaccine could mean for their family.

Here, the latest on vaccine development, safety concerns, and everything you need to know about COVID-19 vaccines.

Vaccine Safety and Regulations

Despite the accelerated pace of Operation Warp Speed, the U.S. Food and Drug Administration (FDA) has strict regulations that must be met before a vaccine can be distributed to the general public. To ensure the safety and effectiveness of a vaccine, it must go through three phases:

  • Phase 1: Early stage clinical trials on 20-100 healthy volunteers to test the safety profile, dose effects, and any adverse effects. If no serious side effects are discovered, the vaccine can move to phase 2.
  • Phase 2: Testing on hundreds of volunteers to determine any short-term side effects or dose effects on different categories of people. If deemed safe, the vaccine can move on to final trials.
  • Phase 3: Hundreds or thousands of volunteers are tested to evaluate the vaccine's effectiveness. This is where the FDA discovers if the vaccine prevents disease when compared to a placebo test and allows researchers to learn more about its safety and any common side effects.

Once this rigorous testing is complete and a vaccine is distributed to the public, phase 4—where the widespread effectiveness or long-term effects are tested on a greater population—will begin. To be considered effective, the FDA says that a vaccine should protect 50 percent of recipients.

"This unprecedented period has called for innovation, speed, and efficiency in vaccine production," says Mobola Kukoyi, M.D., MPH, an emergency physician at Carle Foundation Hospital in Urbana, Illinois who has seen both pediatric and adult COVID-19 cases in the emergency room. "Understandably, this comes with a concern for safety. However, given the different regulatory checkpoints in the phases outlined above, a product is only approved if it meets specific guidelines. My advice to all would be to follow the science."

The good news is that more than one COVID-19 vaccine candidate has already reached the phase 3 stage. According to Dr. Kukoyi, this "means we have something that has not shown any major side effects to date and has produced an acceptable immune response."

Vaccine Front-Runners

With more an 140 vaccines under development worldwide, a handful are showing promise. These are the ones to watch:

1. Moderna

Partnering with the National Institute of Allergy and Infectious Diseases (NAIAD), Moderna, a biotech company in Cambridge, Massachusetts, has created the first vaccine to reach phase 3 testing.

"This is the main event, if you will, in drug development," Stephen Hoge, M.D., president of Moderna, told NBC News.

The first company in the U.S. to begin testing coronavirus vaccines in humans, Moderna—which was given $1 billion in support by the government—will now test as many as 30,000 participants in phase 3, where half will receive the real vaccine and half will receive a placebo.

While early results have been promising, a phase 3 update is expected this fall or winter.

2. Pfizer

Pfizer, working with German company BioNTech and Chinese drugmaker Fosun Pharma, also began phase 3 clinical testing in September. This study will include 30,000 people of a more diverse group, including children as young as 16 years old, as well as people with HIV, Hepatitis C, and Hepatitis B.

With preliminary testing volunteers producing antibodies against SARS-CoV-2, the White House already announced a $1.95 billion deal to buy 100 million doses by December if testing goes well.

3. Novavax

After a successful round of safe early clinical trials, Novavax, a Maryland-based company, has another vaccine to watch. Preliminary studies on monkeys and humans showed the production of virus antibodies, as well as killer T-cells, which can kill cells with the virus.

On July 6, Novavax received $1.6 billion in support from the government to ramp up efforts and produce 100 million doses of a new vaccine by early 2021.

4. AstraZeneca

In collaboration with the United Kingdom's University of Oxford, British-Swedish pharmaceutical giant AstraZeneca has been awarded $1.2 billion to get 300 million doses of its vaccine contender ready for the U.S.

Early trial results have deemed the vaccine safe, but phase 3 clinical trials have been paused to allow for a review process after one participant developed an "unexplained illness." AstraZeneca has said it hopes to bring two billion doses of its vaccine to market early 2021.

"We are rapidly progressing these clinical programs with the hope that results from our late-stage trials, which are currently planned to involve close to 50,000 volunteers collectively, will be available this fall," AstraZeneca executive vice president Menelas Pangalos told USA Today

5. Johnson & Johnson

With $500 million in backing from Operation Warp Speed, Johnson & Johnson's COVID-19 vaccine is shooting to launch phase 3 trials in September with data delivered early next year.

In opposition to other fast-tracked coronavirus vaccines, Johnson & Johnson may take what they learned from their Ebola vaccine trials and include pregnant women in addition to pregnant animals in their late-stage testing.

FAQs

Is the testing moving too fast?

"The speed which this vaccine will be brought to market is unprecedented," says Kevin Kathrotia, M.D., neonatologist and COO of Millennium Neonatology in Charlotte, North Carolina who has cared for babies whose mothers have tested positive for COVID-19. "This is a testament to the herculean effort of scientists and doctors at multiple companies, research facilities, and some of the world's greatest universities." 

And while things are moving faster than usual—it usually takes years to develop a vaccine, and a COVID-19 vaccine is set to be distributed within 24 hours of FDA approval—Dr. Kathrotia says that we should trust the clinical trial process and the fact that a drug brought to market is safe and works. "Having said that, I would wait to go completely back to normal until we see flattening and/or virtual elimination of the virus, which can lag full scale implementation of a vaccine." This means continuing to wear a mask, practice social distancing, washing your hands, and avoiding indoor gatherings or play dates. 

Who should get a COVID-19 vaccine?

We'll have to wait until phase 3 trials are complete to hear about health guidance and make informed decisions, but the federal government has confirmed that the vaccine will undergo a strategic rollout to the public.

"People at highest risk of exposure and severe illness should be prioritized for vaccination," says Dr. Kukoyi. "These include health care workers and other frontline providers; people with conditions that appear to increase COVID-19, severity such as hypertension, diabetes, asthma/lung disease, and obesity; those over age 60; those in long-term health facilities, and those in regions of high prevalence."

Dr. Kathrotia agrees: "Ideally, the vulnerable and high risk populations should be first in line for treatments."

While the vaccine will have a limited distribution initially, it will be free to the public after that.

Is it safe for children?

Vaccines that have been approved by the FDA should be safe, but some current COVID-19 vaccine clinical trials have excluded children.

"There is no reason not to believe that [a vaccine] wouldn't be available simultaneously for adults and children," top infectious disease doctor, Anthony Fauci, told ABC News. However, some vaccine experts believe that children won't be given the COVID-19 vaccine upon initial release and that rigorous clinical trials on kids would need to happen first.

"It would be unfathomable giving children a vaccine that has not been adequately tested in children," Paul Offit, M.D., director of the Vaccine Education Center at the Children's Hospital of Philadelphia who sits on the Food and Drug Administration's vaccine advisory committee, also told ABC News.

We'll know more about who should get vaccinated once a drug is ready for distribution. "We will need to rely on expert guidance after the first round of trials are completed to see how best to extrapolate the data for use in pediatrics, similar to our approach for other medical products," says Dr. Kukoyi.

That said, the CDC and American Academy of Pediatrics (AAP) strongly recommend that all children continue to receive their routine vaccinations during the pandemic.

Is it safe for pregnant women?

Researchers are still studying how COVID-19 impacts pregnant women and fetuses, but pregnant women are not being included in current vaccine clinical trials. In fact, Reuters reports that drugmakers working on the top contenders are "requiring proof of a negative pregnancy test and a commitment to using birth control from women of childbearing age who enroll."

So, what does this mean exactly? Pregnant women may not be able to get a vaccine right away—or at least not until it's been proven safe through testing.

How will I know if my family should get the COVID-19 vaccine?

It's still early and more research is needed, so health experts agree that families should follow the race for a vaccine candidate and let the data speak for itself once testing is complete. The FDA and government officials will likely share vaccination guidance once a drug moves past phase 3.

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