As the coronavirus crisis continues to unfold, many are holding their breath for a vaccine. More than 165 vaccine candidates are currently in development, with several already being tested in human trials.
While researchers attempt to condense a years-long process into just 12-18 months, some parents are left wondering when, exactly, will a COVID-19 vaccine be ready? How well will it work? And will it be safe? Here’s what experts had to say.
When will a COVID-19 vaccine become available?
A vaccine could be ready as early as 2021, according to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and member of the White House coronavirus task force.
“I think Dr. Fauci’s right,” says Dr. Paul Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia. He’s also the co-creator of the rotavirus vaccine, a routinely recommended vaccine given during infancy. “I think we can have a vaccine by the first quarter of next year.”
That’s assuming, of course, that all goes well with the clinical trials currently underway in the U.S. and elsewhere. According to Offit, those trials are essential to the vaccine development process. They are how we know vaccines are safe and effective enough to use.
Once approved, the vaccine could be ready to distribute in the U.S. as soon as the manufacturer makes enough to distribute, Offit says. Vaccines selected for the U.S. Department of Health and Human Services’ Operation Warp Speed — who have already ramped up production — could ship out immediately upon approval.
Once a vaccine is approved, how quickly can my family get it?
Not everyone will be able to access a COVID-19 vaccine right away after one is approved, Offit says. The vaccine will likely first go to populations who are most at risk for coronavirus, such as health care workers, before being distributed to other groups of adults as more doses of the vaccine become available. Who those groups are and how they’ll be prioritized, however, has yet to be determined.
Because children are not part of the initial clinical trials in the U.S., Offit says the vaccine is unlikely to be approved for kids or teenagers right away. More studies will likely be needed to show the vaccine is safe in that age group before parents are given the go-ahead to vaccinate their children against COVID-19.
Is the COVID-19 vaccine being rushed through the testing process? How can we be sure it’s safe?
While it’s true that COVID-19 vaccines are being developed at a much faster pace compared to previous vaccines, that doesn’t necessarily mean manufacturers are cutting corners on safety testing, says Maria Elena Bottazzi, associate dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of the Texas Children’s Hospital Center for Vaccine Development. Her team is one of dozens around the world working on developing COVID-19 vaccines, as well as multiple other vaccines to prevent diseases like Chagas disease and hookworm.
Bottazzi and Offit point to a few ways vaccine makers are able to speed up the development timeline:
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Prioritized money and resources: Dozens of research teams all over the world are working around the clock to make COVID-19 vaccines. Billions of dollars have poured into projects in a matter of months. The sheer amount of resources and manpower dedicated to creating a vaccine against a single disease is rare if not unprecedented.
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Combining phases: Vaccines have to be tested in three phases of clinical trials before they can be approved for use in the U.S. These trials typically happen sequentially (ex. first phase I, then phase II). But some manufacturers are conducting these trials in parallel (ex. phase I and II at the same time) or are condensing multiple clinical trial phases together to save time, while still testing the vaccine for safety and effectiveness or immune response.
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Expedited manufacturing: Making huge quantities of vaccine is time-consuming and expensive, which is why manufacturers usually wait until a vaccine is licensed before they start production. Several vaccine makers, however, are saving time by ramping up manufacturing now (while clinical trials are still underway) and starting the process of producing a large number of doses of the vaccine so that it’s ready to distribute immediately after being approved for use.
“The one step that cannot be skipped and cannot be truncated is a large phase III [clinical] trial,” Offit says, referring to large-scale studies that test the vaccine against a placebo. So long as, and Offit says this part is absolutely critical, phase III trials are complete and show the vaccine is safe and effective before being approved, Offit says people can be reassured that the vaccine is reasonably safe.
Even so, Offit says it’s natural for people to be skeptical of a COVID-19 vaccine. In addition to the accelerated timeline, some of the vaccines being investigated are using new technologies that don’t have the long track record for safety that currently recommended vaccines do.
Bottazzi agrees we should be cautious. She says any side effects will have to be weighed against the risks posed by the virus. But while the COVID-19 vaccine is unlikely to be 100% risk-free (no medical interventions are), checks and balances already in place will be able to monitor the safety of the vaccine even after it’s approved for use in the U.S.
“Safety assessments never stop,” Bottazzi says.
In fact, both Bottazzi and Offit agree that the first vaccine approved to protect against COVID-19 will likely not be the last.
“If you look at the history of vaccines, you never develop one vaccine and then say, ‘I’m done,’” Bottazzi says. As researchers continue to learn more about the virus, vaccines and the body’s response, they will likely continue to apply that knowledge to develop increasingly safer and more effective vaccines.
How effective will the COVID-19 vaccine be, and how long will immunity last?
Offit says we won’t know how effective a COVID-19 vaccine will be until phase III clinical trials wrap up. While earlier trials can demonstrate whether someone has an immune response to a vaccine, only phase III trials can tell you how effective the vaccine is.
That said, Offit is optimistic that even if the vaccine doesn’t totally prevent someone from getting sick, it will likely help reduce their chances of being hospitalized or dying as a result of COVID-19.
“I think you can reasonably expect this vaccine could be 70% effective at preventing moderate to severe disease,” Offit says.
He also doesn’t think we’ll need to be vaccinated again every year like we do with the flu vaccine, though it’s possible we may need multiple doses.
Bottazzi says that even after pre-licensure clinical trials are conducted, it will take time for us to know how long protection from the vaccine truly lasts.
“Will you be protected for three months, six months, a year, two years, three years, 10 years?” Bottazzi says. “We don’t know.”
She’s quick to add, however, that even if COVID-19 vaccines only offer partial protection or require boosters, “it’s still better than having no vaccine, [and] it’s still a useful tool.”
How long after people start getting the vaccine will it be safe to go out, stop physical distancing, stop wearing masks, etc.?
While many are eager to get back to pre-COVID normalcy, that might take a while, Bottazzi says. How soon we can scale back physical distancing measures, mask-wearing, and other precautions will depend on multiple factors, including:
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How many people are immune to COVID-19, either because they were vaccinated or because they became immune after being infected with the virus.
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How high the herd immunity threshold is to prevent the spread of the virus that causes COVID-19 — that is, what proportion of the community has to be immune to a disease to keep it from spreading.
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How effective the vaccine is at preventing someone not just from getting sick but also from spreading the virus to others.
All of which, Bottazzi says, are still open questions.
Is it true that COVID-19 vaccines will implant microchips into the body?
No. Neither Offit nor Bottazzi thought this rumor had any credibility. For starters, Bottazzi says vaccine makers in the U.S. have to disclose every component used to make the vaccine.
“There’s absolutely no way that you can slip in a [micro]chip,” Bottazzi says.
Offit agrees.
“Vaccines are held to a much higher standard of safety [than other medical products],” he says, citing the Vaccine Safety Net, one of the systems in place in the U.S. to monitor vaccine safety. “There’s no equivalent to that on the drug side. There should be, [but] there’s not.”
Will my kids be required to get a COVID-19 vaccine to attend day care or school?
Vaccine requirements are separate from the vaccine approval process, and they are generally set at the state level and by individual institutions or facilities (ex. hospitals) — not by the federal government. So it’s difficult to say who will end up being required to receive the COVID-19 vaccine or when, but Offit doesn’t think mandates will be necessary for people to get vaccinated.
“This virus is killing a thousand people a day,” Offit says. “I think if we have a safe and effective vaccine, people will line up to get it.”