Vaccine Q&A
Readers have questions as distribution nears
Are there side effects? Can I choose which vaccine I want? How immune will I be to COVID-19? USA TODAY is answering these questions and more, and we’re responding to any other questions our readers may have, too.
Vaccines are on the horizon in the U.S., and distribution could begin by mid-December.
Two companies – Pfizer and Moderna – have applied for emergency use authorization from the Food and Drug Administration for their two-shot vaccine candidates. More companies are expected to apply in the coming months.
On Wednesday, the United Kingdom became the first Western country to approve the widespread use of Pfizer’s vaccine, making it one of the first countries to begin vaccinating.
As vaccines are being produced in record time, what do we know about these shots? What are the side effects? Will you be immune? And will you have to take the vaccine once or every year?
When will the vaccine be out?
More than 200 vaccine candidates were under development as of last month, with 48 in clinical trials, according to the World Health Organization. Drug companies Pfizer, Moderna and AstraZeneca have the leading candidates. Pfizer is collaborating with German company BioNTech, and AstraZeneca is working with Oxford University.
There are no authorized COVID-19 vaccines in the U.S. yet, but preparations for distribution are ramping up. Under FDA rules, a vaccine cannot be shipped to administration sites until it has been either licensed or authorized. Operation Warp Speed, the White House-led initiative to develop and distribute vaccines, plans to begin the first vaccine deliveries within 24 hours of FDA authorization.
The FDA is expected to authorize Pfizer’s vaccine by mid-December. Charter flights bringing Pfizer’s COVID-19 vaccine to the United States from Belgium began Friday, the start of what the Federal Aviation Administration calls the first “mass air shipment” of a coronavirus vaccine.
Biotech company Moderna applied Monday for an emergency use authorization from the FDA. Meanwhile, Astra
Zeneca/Oxford faced scrutiny over interim results from trials in the U.K. and Brazil, out last week, showing 60% effectiveness when its vaccine was given in two equal doses and 90% among a much smaller group that accidentally received a half-dose the first time.
Moderna said recently it will have 20 million doses available in the U.S. by the end of this calendar year and another 500 million to 1 billion next year. Pfizer has said it will have as much as 50 million doses of its vaccine manufactured by the end of this year, and another 1.3 billion next year.
What are the side effects?
Most people who get a vaccine will endure side effects, particularly after a second dose. All three candidate vac
cines reported mild or moderate side effects, mostly pain at the injection site, fatigue, and aching muscles and joints for a day or two.
“A sore arm and feeling crummy for a day or two is a lot better than COVID,” said Dr. William Schaffner, professor of health policy and of preventive medicine at the Vanderbilt University School of Medicine.
If someone is going to have a bad reaction to a vaccine, it is likely to occur in the first six weeks after vaccination, according to medical experts. But experts still don’t know the long-term effects of the vaccines and won’t know until after the trials are completed and researchers monitor participants in the real world for years after.
Will the vaccine be safe if you are pregnant?
Pregnant women are at increased risk for severe illness from COVID-19, according to the Centers for Disease Control and Prevention. But there is no data on how pregnant women respond to the Pfizer or Moderna vaccines because they were not included in the trials.
Experts are still debating when vaccines should in general be tested on those who are pregnant. Historically, major vaccines have not been tested during pregnancy because of concerns that both the pregnant person and fetus would be at risk for complications.
The Advisory Committee on Immunization Practices, an independent group convened by the CDC to offer advice on who should get specific vaccines and when, have discussed the question of whether pregnant or nursing health care workers should receive the vaccine. Further guidance would be forthcoming, officials said.
Can I choose the vaccine I want?
The vaccine you’re offered will depend on how close you live to a medical center equipped with medical-grade ultracold freezers, said Jeylan Mammadova, health care analyst for investment research firm Third Bridge.
The Pfizer vaccine must be kept super cold – at the temperature of dry ice – making it harder for most pharmacies and doctor’s offices to accommodate it. The vaccine can be stored for up to five days at normal freezer temperatures. It is shipped in boxes that contain 975 doses, so a vaccine administration site would have to be able to use up all those doses within five days, which will likely need to be at a larger medical center.
As for Moderna’s vaccine, Schaffner said that potential vaccine may be more widely distributed as it can be refrigerated for up to a month before being used. Similarly, the AstraZeneca/Oxford vaccine can be kept refrigerated throughout, which should make it easier to deliver to areas that do not have easy access to freezers.
“Moderna’s vaccine will be more available in suburban and rural areas where it’s harder to get access to ultracold storage and where the ability to use
975 doses of vaccine within five days is more limited,” Mammadova said.
Can you get one dose from one vaccine and another from a different vaccine?
Most of the vaccines at this stage require two doses to become maximally effective. The Pfizer/BioNTech shots are given 21 days apart, Moderna’s are given 28 days apart, and AstraZeneca/Oxford’s about a month apart.
Because the vaccines differ in composition, storage and time between the two doses, experts say people must take the same vaccine for both doses.
“You have to get the same vaccine the second time,” Schaffner said. “We will have no information on what we call ‘mixing and matching.’ ”
It’s possible research will show that getting a similar type of vaccine – one within the same “class” – would be effective, but no one knows at this point, said Dr. Greg Poland, director of the Mayo Clinic’s Vaccine Research Group.
What is the level of immunity after one shot?
Pfizer and Moderna have not yet released information from their Phase 3 trials about the level of immunity someone might get from the initial shot of their vaccines. Earlier phase trials suggested that two shots would be necessary to provide strong and enduring protection.
The vaccine by AstraZeneca/Oxford, meanwhile, has faced scrutiny over interim results from trials that showed 60% effectiveness when its vaccine was given in two equal doses and 90% among a much smaller group that accidentally received a half-dose the first time.
As with other vaccines – like the measles, mumps and rubella vaccines – experts say it’s never too late to get the second dose even if it’s after their
scheduled vaccination appointment. Patients won’t have to retake their first dose, so physicians urge them to call their health care provider to reschedule a time for their second dose as soon as it becomes available.
Which vaccines will be only one shot?
Johnson & Johnson is developing a single-dose vaccine. The company’s chief scientist said last month that the company expects to have all the data it needs to file for authorization by February or sooner.
“In a pandemic, a single shot is definitely important globally,” Dr. Paul Stoffels, J&J’s chief scientific officer, told Reuters. A two-shot vaccine “is a very significant operational challenge. More so in health care systems which are less well-organized.”
If you already had COVID-19, should you still get vaccinated?
Yes. People who have had COVID-19 “may be advised” to get the vaccine, “due to the severe health risks associated with COVID-19 and the fact that reinfection with COVID-19 is possible,” according to the CDC.
While serological testing can determine if a person has virus-specific antibodies that can protect against SARSCoV-2, the virus that causes the disease COVID-19, experts say it’s still unknown how long those antibodies will be present in the body after infection.
“We don’t know for how long the protection will last after you’ve recovered,” Schaffner said. “It’s always good to get vaccinated because it provides the best protection.” He said there will be no serological tests to screen for prior infection at the vaccination sites.
There’s no evidence that a vaccine poses any risk to people who have had COVID-19. But medical experts urged patients not to go to the doctor’s office for a scheduled vaccination if they have symptoms of COVID-19. That would pose a risk of transmission, as well as confound the cause of any potential side effects, Poland said.
Once you get vaccinated, can you still get sick?
Yes, it is possible that you could still get sick or transmit the virus to someone else, even after having received the vaccine, according to experts. “The vaccines are 90% effective. That means that there’s a small chance you could encounter the virus and still get sick,” Schaffner said.
It’s also possible to get sick if you don’t give the vaccine enough time to provide protection. It typically takes a few weeks for the body to build immunity after vaccination, the CDC says.
A third possibility? The vaccine could prevent you from getting the disease, but not from transmitting the virus to someone else. “To prevent asymptomatic infection and transmission, you need what’s called sterilizing immunity,” Poland said. “To prevent severe disease and it’s complications, you need only to develop neutralizing antibodies. It doesn’t have to be sterilizing.”
It’s not yet clear if the COVID-19 vaccines can produce sterilizing immunity.
How long will the vaccine last?
Though the vaccines have proven protective against the virus, there’s no data that shows how long that protection can last, Schaffner said. “That protection may wane over time, and you may be susceptible again,” he said.
A vaccine could trigger an immune response that lasts longer in some people than in others, Poland said.
It’s also possible that the virus could mutate.
“How often? No one knows. We haven’t actually seen a mutation yet that escapes vaccine-induced immunity, but there are no theoretical or observable reasons why that couldn’t happen,” Poland said.
What would be the cost of the vaccine? Will insurance cover it?
Moderna and Pfizer have agreed to provide the U.S. with 100 million doses apiece, already funded through federal support of manufacturing and distribution. Vaccine doses purchased with U.S. taxpayer dollars will be given to the American people at no cost, according to the CDC.
“However, vaccine providers will be able to charge administration fees for giving or administering the shot to someone. Vaccine providers can get this fee reimbursed by the patient’s public or private insurance company or, for uninsured patients, by the Health Resources and Services Administration’s Provider Relief Fund,” the CDC says on its website.
The Trump administration said in mid-November that Americans living or working in long-term care facilities, including nursing homes and assisted care living centers, will receive vaccinations free through a partnership with the nation’s two largest drug store chains, CVS and Walgreens.