COVID-19 Q&A: Pfizer vaccine gets FDA approval

Gisela Steep

The U.S. gave full approval to Pfizer’s COVID-19 vaccine. What does that mean? U.S. health officials recommend booster shots. What’s the difference between boosters and third doses? These are some of the many questions readers have sent us that we’ve put to health and science experts. This resource will be […]

The U.S. gave full approval to Pfizer’s COVID-19 vaccine. What does that mean? U.S. health officials recommend booster shots. What’s the difference between boosters and third doses? These are some of the many questions readers have sent us that we’ve put to health and science experts. This resource will be updated as more questions arrive, so check back often. Have your own pandemic question? Send it to the Tribune here. Get the latest Chicago COVID-19 information and updates from the Chicago Tribune reporters and editors on our COVID-19 Facebook page.

The Food and Drug Administration approved the Pfizer vaccine. What does that mean?

The U.S. becomes the first country to fully approve the shot, according to Pfizer. The news comes on the heels of a Chicago and Cook County-issued mask mandate (everyone over the age of 2 will have to be masked in indoor public spaces, regardless of whether they’re vaccinated). On Aug. 20, Illinois marked its highest one-day total in COVID-19 cases since late January, with a reported 4,904 new confirmed and probable coronavirus cases.

Dr. Emily Landon, chief health care epidemiologist at the University of Chicago, said the approval is exciting for two reasons:

“A lot of people don’t realize when most medications that we use when they’re approved by the FDA, doctors can use them however they see fit,” she said. “So, a new study comes out saying that you can use aspirin for a new condition. The next day, I can give people aspirin, I can say, ‘Take aspirin for this condition it’s going to help.’ But when you have an emergency use authorization, the FDA only allows you to use it for the specific things that they gave you authorization to use it for, because that’s all they studied at that time.

“Now that we have a full FDA approval, we can use that drug whenever there’s new evidence that tells us a way to use that vaccine that’s better or safer or if there’s a patient that we really think would benefit — say a transplant patient that got three doses and still doesn’t have any antibodies — we can use it now to give them a fourth dose. We don’t need to stick to just the recommendations that they make.

“There’s no rule right now about what to do for an immunocompromised person who got Johnson & Johnson — we know that they need an additional dose in order to be better protected. We know that they’re at too high of a risk, but there aren’t really enough studies for the FDA to approve that. But on an individual basis, if I was seeing a patient in my clinic and the patient and I together felt like the risk of getting another dose of messenger RNA vaccine or Pfizer was low compared to the risk of getting COVID, we should just do it now. And that’s a big difference.

“The second reason why FDA full approval is really great is because while health professionals really understand that that’s really not needed to prove that something is safe, it may make some people feel more comfortable to get the vaccine. It’s a bar that some people said, ‘Well, I’ll get it when this happens,’ and it’s happened. Now, I think that should really help people have confidence, and I really hope that people who told themselves when they had the full approval, that’s when they’ll feel comfortable. This is your chance; you’ve got it now. Don’t let any other doubts creep into your mind. Trust in the science, go get your vaccine.”

More than 200 million Pfizer doses already have been administered in the U.S. since emergency use began in December. Just over half of the U.S. population is fully vaccinated with one Pfizer, Moderna or Johnson & Johnson.

Moderna has also applied to the FDA for full approval of its vaccine. J&J said it hopes to do so later this year.

— Darcel Rocket and The Associated Press

U.S. health officials recommend booster shots for some. What’s the difference between boosters and third doses?

Booster shots for COVID-19 were being discussed early this summer, now U.S. health officials recommended a third shot for some people with weakened immune systems, such as cancer patients and organ transplant recipients.

The Biden administration announced that COVID-19 booster shots will be available by mid-September for those eight months into being fully vaccinated with the Pfizer or Moderna vaccine. The plan, as outlined by the Centers for Disease Control and Prevention and other health agencies, is subject to a Food and Drug Administration evaluation of the safety and effectiveness of a booster and a review by a CDC advisory panel. Special clinics to provide a third COVID-19 shot to immunocompromised individuals are up and running in Oak Park, with over a dozen already dispensed.

Dr. Emily Landon, chief health care epidemiologist at the University of Chicago, clarified some questions about the booster/third dose of the COVID-19 vaccine.

Is there a difference between booster shots and third dose vaccinations?

Yes. A booster is given to people who got a full course of a vaccine and developed a good response. For some vaccines, antibodies and other aspects of a person’s initially strong immune response start to decrease (or wane) over time. When that happens, people are offered booster doses to pump their immune response back to previous levels.

Third/additional doses of COVID-19 vaccines are for people who received the complete series of vaccines but then their immune systems didn’t have a good enough response. Evidence shows these are generally people whose immune systems are weaker. That’s why the FDA and CDC are recommending an additional dose for immunocompromised individuals.

Who is considered immunocompromised?

People who have had or are receiving:

  • Organ transplants
  • Stem cell transplants within the past two years
  • Active cancer treatment for tumors or blood cancer and are undergoing chemotherapy
  • Severe primary immunodeficiency
  • Advanced or untreated HIV
  • Active treatment with high-dose corticosteroids or other drugs that may suppress immune response.

You are not eligible for a third dose of the vaccine at this time if you are healthy, do not have one of these conditions, or do not take certain immunosuppressive medications. If you aren’t sure whether your condition counts, contact your doctor. Other people will be able to get booster shots as early as fall 2021.

If I am immunocompromised, will I be fully protected after I get my third dose?

No. If you are immunocompromised, a third dose is supposed to provide better protection from COVID-19, but it may not provide you with the same level of immunity as healthy people. In studies, most participants who had any immune response to the first two doses did better after a third dose, but some people didn’t.

Does my booster vaccine need to be the same brand as my initial vaccine?

If possible, yes. The CDC recommends booster doses match the original mRNA vaccines people received earlier. If you absolutely cannot find a matching dose of vaccine, it would be OK to get the other one. There is not enough data yet to know whether immunocompromised people who got the Johnson & Johnson vaccine need another dose, but scientists expect to know more soon.

— Darcel Rockett, Associated Press

When is it a HIPAA violation to disclose proof of vaccination?

This may be something many misunderstand. According to Andy Reeder, associate vice president and privacy officer at Rush University Medical Center, people may confuse HIPAA with an individual’s desire to assert personal privacy. HIPAA constrains what health care staff can or cannot disclose about someone in their care, but does not typically apply, he explained, in the case of private individuals or businesses requesting information in the interest of public health. For example, asking someone’s vaccine status is not a HIPAA violation. But a doctor sharing a patient’s vaccination status without the patient’s permission is a violation.

What is the risk for breakthrough infections?

According to Dr. Robert Murphy, executive director of the Institute for Global Health at Northwestern University Feinberg School of Medicine, “The vaccine is about 90% effective against the delta variant, so 1 person in 10 who gets vaccinated and is exposed to SARS-CoV-2 will have a breakthrough infection.”

“Anybody is at risk for it, not just the immune-compromised,” Murphy said. “It’s athletes. It’s totally healthy people. Certainly, the immune-compromised are at a higher risk because they can’t mount a strong enough immunologic response to the vaccine. Older people may also have a weaker response to the vaccine.”

Still, Murphy has some encouraging news for those who are fully vaccinated.

“The end game is most people who get breakthrough infections either have very mild symptoms or no symptoms. They rarely end up in the hospital, and they don’t die,” Murphy said, adding: “The big question is how infectious are they? That’s what we are trying to find out.”

Murphy is among a group of doctors at Northwestern and other universities who are investigating the infectiousness of vaccinated students who got COVID-19, with the results of their study expected in the coming months.

Is the delta variant causing more breakthrough infections?

Mercedes Carnethon, vice chair of preventive medicine at Feinberg, said doctors are seeing breakthrough infections, adding that “while we know that no vaccine is 100% effective, it feels frightening.

Experts remain unsure why the “rate of infections — both new and breakthrough — appear to be picking up,” she said.

“One concern is the delta variant is evading the vaccines. Another concern is any virus that causes a high viral load would break through vaccine protection — and there is evidence that the delta variant does cause higher viral loads earlier in the course of infection,” Carnethon said.

“We will never get away from these concerns because the virus will continue to mutate itself into new variants so long as it circulates in the population, and the biggest space it has to circulate is among the unvaccinated,” she said.

Should vaccinated people wear masks?

Even prior to Illinois Gov. J.B. Pritzker’s mask mandate for Illinois schools in early August, Dr. Benjamin Singer, assistant professor of medicine in pulmonary and critical care at Feinberg, said, “vaccinated people may still choose to wear masks if they or someone in their household contact is at particularly high risk.”

“In places with low vaccination rates and high community transmission, I think it makes clear sense to add back masking when you are indoors as an additional layer of protection from a more contagious variant,” Singer said.

Should your behavior change if you are an older adult?

“All vulnerable individuals, either due to age or pre-existing conditions, should take precautions because if they are infected or re-infected it may not be a mild illness,” Carnethon said. “The highest rates of mortality consistently have been older adults, which is traditionally defined as 65 and older.”

“However, the risks for severe illness go up with each decade of life, and there is no age cutoff where the risk of illness is significantly lower,” she said. “There are 40-year-olds with the health profiles that we know are associated with severe illness—obesity, diabetes, uncontrolled hypertension, cancer or preexisting heart disease. Those individuals, regardless of their age, are just as vulnerable as older adults and should also take precautions.”

It’s now being recommended that pregnant individuals be vaccinated against COVID-19. What changed?

The move is a turnabout from earlier in the year, when data was not there pertaining to pregnant women, vaccinations and clinical trials.

Northwestern Medicine’s Chief of Obstetrics Dr. Emily Miller, a member of the Society for Maternal-Fetal Medicine’s COVID-19 Task Force, helped write the new language from “should not be excluded” to “recommend vaccination.” Miller said that the change is in light of coronavirus cases rising.

“The original data that showed us that the vaccines were safe and effective excluded pregnant people,” Miller said. “So, the national organizations had to temper their recommendation since they had no data on pregnancy — the recommendation was to individualize that decision making based on that person’s risk as far as SARS-COV2 acquisition. We would individualize and not withhold the vaccine, but we didn’t feel like we could initially recommend it just because we had no data. Now we have data that the vaccine works in pregnant people, reduces their risk of COVID-19, and we don’t see any signals that there’s an increased risk of adverse pregnancy outcomes. And so now that we have these data we can say the benefits of the vaccine outweigh the risks.”

Pregnant individuals who have decided to wait until after delivery to be vaccinated may be inadvertently exposing themselves to an increased risk of severe illness or death. Those who have recently delivered and were not vaccinated during pregnancy are also strongly encouraged to get vaccinated as soon as possible.

Miller hopes the recommendation from the professional societies emphasize how important vaccinations are and will help sway some people who have yet to be vaccinated. According to the Centers for Disease Control and Prevention, almost 140,000 pregnant people have been vaccinated.

“I know that it’s stressful, and people want to be safe but I think we have to recognize that it’s not safe to be unvaccinated in a pandemic,” she said. “I think people are forgetting that not getting the vaccine means you’re at risk of infection. Particularly now when we’re entering what is it? Our fourth or 2000th wave?”

Dr. Carmen Adams, obstetrician and gynecologist at Cook County Health, received her first COVID-19 vaccine shot when 37 weeks pregnant. She received her second shot about two weeks before she gave birth to her first child. She said the science behind the vaccines led her to her lightbulb moment to take the vaccine.

“The only vaccines that we don’t give to pregnant women are live vaccines and knowing that made it safe,” Adams said. “I did not want to have a COVID infection close to delivery, with delivery (I was still seeing patients in the hospital basically until I delivered) and I didn’t want to take a chance getting an infection and getting severely sick or having to be separated or isolated from my baby after delivery.”

Adams feels better as a provider to say that practitioner societies are recommending taking the vaccine. And in turn, she thinks her patients will feel more comfortable receiving it.

“I like to tell my patients you should get it to protect yourself so that you don’t get sick, but I also think there’s really good data out there that’s showing that there’s antibodies created from pregnant women that go to the placenta and to the baby that are likely going to protect the baby for several months,” she said. “I like to emphasize that not only can we protect ourselves but likely protect our babies as well and I think that that is encouraging too.”

Chicago public health Commissioner Dr. Allison Arwady said in an Aug. 3 news conference that the delta variant is more contagious, but there’s no clear data that the variant is making people sicker or putting them in the hospital more than other variants.

“The thing that is extremely clear is that the vaccines are working really well,” she said. “And where people are fully vaccinated, I’ve not seen anything that has made me change my behavior at this point except putting my mask on inside while we get through this surge. All we can say is here is the data we have now, here’s the recommendation, and stay up with the science of it.”

With the new surge of COVID-19 infections, the Food and Drug Administration has accelerated its timetable to fully approve Pfizer-BioNTech’s coronavirus vaccine, aiming to complete the process by the start of next month, according to reports.

Can COVID-19 push someone into diabetes?

According to Dr. Sirimon Reutrakul, associate professor in the endocrinology, diabetes and metabolism division at UI College of Medicine, there are some suspicions in the medical community that there’s some association between diabetes and COVID-19. Research is going on to see if there is causation.

Reutrakul said she’s seen people come in with COVID-19 with new onset diabetes, though not many.

“I think this is why people are trying to do these studies,” Reutrakul said. “I don’t know if you could prevent yourself from getting diabetes if you’ve become infected with COVID-19 that’s a bit extreme. But I think some of the symptoms of COVID-19 and some symptoms of diabetes may overlap (fatigue and weight loss), so that’s one thing to think about.”

Until there’s something definitive, she said people should keep their eye on the science.

Her suggestion: “If you have a fever, sore throat, a runny nose, those are not symptoms of diabetes. If you have COVID-19 and have significant weight loss, drinking/urination a lot, those may be indicating that you might have something else on top of COVID,” so go get checked.

Illinois has a new mask mandate. Where does it apply?

Gov. J.B. Pritzker issued a new mask mandate for preschool through high school students and staff statewide, effective immediately. Universal masking also will be required in long-term care facilities statewide.

The requirement will apply to all indoor athletic activities in schools, Pritzker said. Masks won’t be required for outdoor sports and activities.

The move comes as a new school year approaches and a fourth coronavirus spike is occurring in the state. Chicago Public Schools, the state’s largest district, had already made the decision to require masks, but other districts have made them optional in the face of vocal opposition from some parents.

“Far too few school districts have chosen to follow the federal Centers for Disease Control and Prevention prescription for keeping students and staff safe,” Pritzker said in issuing the new requirement, which applies to public and private schools, and day care centers. “Given the CDC’s strong recommendation, I had hoped that a state mask requirement in schools wouldn’t be necessary, but it is.”

— Dan Petrella, Lisa Schencker, and Madeline Buckley

What do we need to know about the variants, like delta or lambda?

First, many called it simply the coronavirus, then COVID or COVID-19. Now, we are keeping track of descriptors like alpha, beta and gamma, the variants of COVID-19. The World Health Organization created this naming system to make them easier to publicly discuss.CQ

The Illinois Department of Public Health lists COVID-19 variants of concern. CQAs of their most recent data, updated July 26 , the original alpha still accounts for the majority of cases, with 6,973 of the total 10,886 cases. Next up is the gamma variant, with 2,641 cases, followed by 636 cases of the delta variant.

Viruses are constantly changing through mutation, which results in new variants, something scientists expect to monitor.

Should we wear masks inside?

Previously, the CDC had eased mask guidelines, saying fully vaccinated people did not need to cover faces.

How many minutes is considered exposure to someone with COVID-19?

But given that researchers are concerned the delta variant might be more transmissible, Dr. Stephen Schrantz, an infectious disease pediatrician at University of Chicago Medicine, said delta’s increased contagiousness “should give the CDC some reason to re-examine its definition of ‘an exposure.’” He added, “I will not be surprised if the CDC does amend its recommendations regarding the duration of contact as more data accumulates.”

When students head back to school next month, should they still wear masks?

According to the American Academy of Pediatrics’ latest guidance for opening schools for the start of the 2021-22 school year, the nation’s pediatricians recommend that everyone older than age 2 wear masks, regardless of vaccination status.

In the AAP’s updated guidance July 19 issued earlier this week, officials said they are recommending “universal masking because a significant portion of the student population is not yet eligible for vaccines, and masking is proven to reduce transmission of the virus and to protect those who are not vaccinated.” Officials said research has shown that “opening schools generally does not significantly increase community transmission with masking and other safety measures in place.”

Above all, the AAP is urging all who are eligible to be vaccinated to protect against COVID-19, and is recommending a “layered approach” to ensure schools are safe for all students, teachers and staff. According to Dr. Sara Bode, chairperson-elect of the group’s Council on School Health Executive Committee: “This is why it’s important to use every tool in our tool kit to safeguard children from COVID-19. Universal masking is one of those tools, and has been proven effective in protecting people against other respiratory diseases, as well. It’s also the most effective strategy to create consistent messages and expectations among students without the added burden of needing to monitor everyone’s vaccination status.”

The AAP is also calling for making in-person learning a priority, and advising schools to be prepared to address students’ mental health needs.

What other steps should schools take to keep kids safe?

The AAP underscores the Centers for Disease Control and Prevention’s recommendations for building ventilation, testing, quarantining, cleaning and disinfection into the updated guidance.

“We need to prioritize getting children back into schools alongside their friends and their teachers — and we all play a role in making sure it happens safely,” said Dr. Sonja O’Leary, chairwoman of the AAP Council on School Health.

“The pandemic has taken a heartbreaking toll on children, and it’s not just their education that has suffered but their mental, emotional and physical health. Combining layers of protection that include vaccinations, masking and clean hands hygiene will make in-person learning safe and possible for everyone,” O’Leary said.

Suffering from lingering COVID-19 symptoms after dealing with coronavirus? Illinois looking to help long haulers.

Long COVID-19 is a range of symptoms that can last weeks or months after first being infected with COVID-19 or can appear weeks after infection, according to the Centers for Disease Control and Prevention. Symptoms of long COVID-19 vary greatly — some of the most common symptoms include fatigue, difficulty breathing, difficulty concentrating, body or muscle aches, problems with taste or smell, trouble sleeping, feeling anxious or depressed, dizziness and weakness — and the risk of becoming a long-hauler increases with the severity of illness after infection.

It can happen to anyone who has had COVID-19.

Estimates suggest 10% to 30% of people who get COVID-19 will develop long COVID-19, according to Dr. Jerry Krishnan, University of Illinois Chicago associate vice chancellor for population health sciences and professor of medicine and public health.

“The CDC estimates that about 33 million Americans tested positive for COVID-19, which means 3 to 10 million Americans likely have or have had long COVID,” Krishnan said.

National and local initiatives are being formed to understand and treat patients with the condition.

UIC has been selected to lead an Illinois-based team for the U.S. RECOVER consortium. Krishnan is a part of the team spearheading the efforts to bring health centers, community-based organizations and faith-based organizations in Chicago, Peoria, Rockford and Urbana together to form a network of state resources for a directory that can be available to people with long COVID-19.

There is no test for long COVID-19, Krishnan said. Serology tests used to look for antibodies in the blood are the best gauge for diagnosis, he said. Finding a doctor who knows about testing and best practices from current data is necessary to prevent confusion with other health conditions, he said.

“We’re going to have to rethink where to care for these individuals,” Krishnan said. “The other piece is we got to be careful because we don’t know yet what to do for these individuals.”

Which states were added back to Chicago’s emergency travel advisory?

Missouri and Arkansas are the only two states where unvaccinated travelers returning to Chicago will be asked to abide by quarantine or COVID-19 test requirements, according to the Chicago Department of Public Health. The list is updated every two weeks and travel guidance on new states goes into effect on July 16.

Missouri and Arkansas were added this week because they met the threshold of at least 15 daily cases per 100,000 residents. Once a state breaches that ceiling, travelers returning from there to Chicago are advised to be fully vaccinated, quarantine for 10 days or test negative for COVID-19 no more than 72 hours before arrival.

Since the start of June, no states had been on the city’s COVID-19 travel restriction list thanks to vaccinations. But as the more contagious delta variant began spreading and states hit a wall with vaccine outreach, positive tests began creeping up again. That variant has become the dominant strain in the country.

What do we need to know about the delta variant?

Local health officials say nearly 10,000 cases of the various COVID-19 variants reported in Illinois as of June 27 are not yet cause for alarm.

Gov. J.B. Pritzker said June 28 that the delta variant already is a “growing presence in Illinois,” and officials expect it to be the dominant strain statewide by fall.

Dr. Emily Landon, chief health care epidemiologist at the University of Chicago, said the delta variant is “even more contagious than the alpha variant,” but vaccination efforts throughout the state should keep the spread limited.

“Fully vaccinated people really don’t need to be concerned,” Landon said. “All of the vaccines that are available in the U.S. work well with the delta variant but don’t work as well as protecting you from the original COVID. But, we’re talking about 95 and 90%, which is not significant enough to make me want to change how people are behaving.

“Where you see fewer vaccinated individuals, you’re more likely to have an outbreak. When you have COVID spreading in your community, everybody is at higher risk, including the people that are vaccinated. Certain communities, certain parts of the country are more likely to be protected because they have more people who are vaccinated.

“Unvaccinated children are still unvaccinated. Even if the rest of the family is all vaccinated, if you take unvaccinated kids to a COVID hot spot, they could get it and bring it back to your community and spread it.”

— Shanzeh Ahmad and Alice Yin

Will extended mask-wearing affect our susceptibility to germs?

“By adulthood, we have come into contact with many types of viruses and bacteria,” she said. “Our immune system has created memory to these pathogens, so that when we come into contact with them we can make antibodies to fight off the disease.”

Vaccines are important for novel pathogens, like COVID-19, she noted.

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