COVID-19 Q&A: Emergency use authorization

COVID-19 vaccines from Pfizer, Moderna, and Johnson & Johnson have all received an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) and are considered safe and effective at preventing serious illness and even death from COVID-19.

The following is information found on the FDA’s website. It has been edited for length and clarity. Visit the FDA link to read the full Q&A and learn more about each vaccine.

What is an EUA?

An emergency use authorization is a process that helps make needed medications and vaccinations available during emergencies. An EUA does not affect vaccine safety, because it does not impact development, such as research, clinical studies, and the analysis of side effects and adverse reactions. Instead, it speeds up manufacturing and administrative processes.

Are the COVID-19 vaccines rigorously tested?

Yes. All vaccines follow the same testing processes, whether they are approved for emergency use or through a typical license. Clinical trials evaluated investigational COVID-19 vaccines in tens of thousands of study participants to generate the scientific data and other information needed to determine safety and effectiveness. These clinical trials are conducted according to the rigorous standards set forth by the FDA.

Currently, millions of Americans have safely chosen to take the COVID-19 vaccine.

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A reminder from DHW Director Dave Jeppesen: 98.7 percent of COVID-19 hospitalizations are Idahoans with no record of being fully vaccinated

The facts are clear. The COVID-19 vaccine is safe and effective. Currently, the vast majority of COVID-19 cases, hospitalizations, and deaths among Idahoans occurred among those who were not fully vaccinated when they became ill or tested positive for the virus that causes COVID-19.

  • From Jan. 1 through July 3, Idaho has had 52,699 cases of COVID-19. 497 (0.9 percent) of those had a record of being fully vaccinated, 52,202 (99.1 percent) had no record of being fully vaccinated.  
  • In that same time period, 2,479 Idahoans were hospitalized for COVID-19. 32 (1.3 percent) had a record of being fully vaccinated. 2,447 (98.7 percent) had no record of being fully vaccinated.
  • Also in that same time period, 433 Idahoans died from COVID-19. Five (1.2 percent) had a record of being fully vaccinated. 428 (98.8) percent) had no record of being fully vaccinated.

Getting the vaccine is a choice, but it is a choice that protects your families and fellow residents … and you. I hope you stay healthy. I want your parents and children to stay healthy. If you are looking for a place to get a vaccine, you can find a mobile clinic near you or a walk-in location or pharmacy near you.

As of today, 51.3 percent of adults aged 18 and older in Idaho have received at least one dose of the vaccine, and 76.9 percent of those age 65 and older have received one dose of the vaccine. 

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An update from DHW Director Dave Jeppesen: Latest research helps us better understand vaccine confidence among Idahoans

At certain times during the COVID-19 pandemic, Idaho conducted research to help us understand current awareness and understanding of COVID-19, safety precautions, and the COVID-19 vaccine. Recently, the state conducted a survey with 300 Idahoans who are currently unvaccinated. We wanted to understand if they will choose, at some point, to get vaccinated and what would be the reason. And, if they are choosing to not get vaccinated, what has led them to that personal decision?

Some highlights of the survey results include:

  • Many people are in the “wait and see how things go” mindset. This means people will decide, in their own time, when they will get the vaccine. They are not against getting vaccinated, but they may be looking for a trigger (travel, school starting, etc.) or time and convenient access to the vaccine because of their busy lifestyles.
  • Many people also indicated they wanted to wait for a year or so to see how things were going.
  • Most unvaccinated people are not concerned about getting COVID-19. They do express some concern about and the possible side effects of the available vaccines. (Note: Some more common side effects are swelling, redness, and pain at the injection site; fever; headache; tiredness; muscle pain; chills; and nausea. Serious side effects are extremely rare.)
  • For those who are likely to get the vaccine, convenience is a major concern. Idahoans also indicated a preference for getting the vaccine at a pharmacy.
  • Those likely to be vaccinated in the future are concerned about time off work for the appointment OR if they experience side effects. (Note: Gov. Brad Little took this concern to heart and has set the example for other leaders in Idaho. He gave state employees four hours of paid leave if they have gotten the COVID-19 vaccine or if they will be doing so in the future).
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COVID-19 Q&A: Vaccine for 12-15 year-olds

When can a 12-15 year-old receive a COVID-19 vaccine?

Today! Or whenever it’s convenient. As of May 12, 2021, adolescents 12-15 years old can receive the Pfizer-BioNTech COVID-19 vaccine. The vaccines are given in the same dosage as for adults: two 0.3 mL doses of vaccine 21 days apart.

Is the COVID-19 vaccine safe and effective for adolescents 12-15?  

Yes. COVID-19 vaccine has been administered during clinical trials to more than 1,000 adolescents ages 12-15 years old. None of the adolescents in the phase 3 clinical trials had unusual or severe reactions to the vaccine. Of those in the trial who received the vaccine, zero adolescents contracted COVID-19, while 18 adolescents in the placebo group contracted COVID-19.

What are the most likely side effects for adolescents?

The most common side effects of the vaccine among adolescents were similar to those for older adolescents and adults: sore arm at the injection site, swollen lymph nodes, headache, chills, mild fever, and fatigue. Over the counter medications can be given to adolescents after their vaccine to alleviate these symptoms, if they occur.

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A reminder from DHW Director Dave Jeppesen: Working together toward a new normal

COVID-19, no matter who you are or where you live, has changed your life. But as the rate of infections begin to slow in Idaho (only about 10 cases per 100,000 residents) and more and more Idahoans choose to get vaccinated each day, the signs of recovery are everywhere. More activities are taking place, vacations are being planned, and more and more people are slowly returning to their pre-pandemic lives.

And, the Centers for Disease Control and Prevention (CDC) recently eased its guidelines on wearing masks outdoors for fully vaccinated people: no need to cover your face anymore unless you are in a big crowd of people. That’s good news for the more than 500,000 fully vaccinated Idahoans.

The new normal looks and means something different to each of us. For me, it’s time with my grandkids.

In Idaho today, we are still working diligently to help those who choose to get vaccinated to be able to do so at their convenience. Those 16 and older are now eligible to get the COVID-19 vaccine. There is no cost to you, and it is now more convenient than ever to get the vaccine. If you choose to get the vaccine, you can do so at your convenience. On the covidvaccine.idaho.gov website, you can:

  • Sign up and have a provider call you
  • Use the vaccine finder and find a walk-in location near you (Walmart, Albertsons, Bi-Mart, Walgreens, Customedica, and Fred Meyer all are accepting walk-in customers)
  • Schedule an appointment at your convenience on line or calling a local provider
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COVID-Q&A: Grant funding for mobile clinics is now available

In an effort to provide vaccination opportunities to everyone 16 and older where they live, work, and play, the Department of Health and Welfare (DHW) announced a new funding opportunity last week to establish and operate mobile, off-site, walk-in, and special COVID-19 vaccination clinics in underserved communities, including racial and ethnic minority populations and rural communities, among others.

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An Update from DHW Director Dave Jeppesen: Are you fully vaccinated?

More than 435,000 Idahoans are now fully vaccinated, and another ~146,000 Idahoans have received one dose of a two-dose series. If you are one of the 16 and older Idahoans who have chosen to get the COVID-19 vaccine, I want to thank you for protecting yourself, your family and friends, and your community.

One quick reminder: Anyone 16 and older is now eligible to get the vaccine, and the vaccine is free to you. There are no out-of-pocket costs.

Many people in Idaho have chosen to get the vaccine as soon as it was available. There are others who are busy with kids or work or other priorities and are waiting to get the vaccine when it is more convenient. In the coming weeks, you will see vaccine providers (such as local pharmacies) working to make the vaccine more easily available to you.

You are considered fully vaccinated two weeks after your second dose in the two-dose series of the Pfizer or Moderna vaccines. If you received the J&J vaccine before the pause, you are considered fully vaccinated two weeks after getting the shot.

What happens after you are fully vaccinated?

If you have been fully vaccinated:

  • You can gather indoors with others who are fully vaccinated, and no mask is needed.
  • You can gather indoors with unvaccinated people from one other household (for example, visiting with relatives who all live together) without masks, unless any of those people or anyone they live with has an increased risk for severe illness from COVID-19.
  • If you’ve been around someone who has COVID-19, you do not need to stay away from others or get tested unless you have symptoms.

For now, even if you are fully vaccinated, there are some things that have not changed just yet. For example:

  • You should avoid medium or large gatherings.
  • You should still watch for symptoms of COVID-19.
  • You still need to follow guidance at your workplace.
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COVID-19 Q&A: Vaccine safety

Q: Can COVID-19 vaccine cause infertility in men and women?

A: There is no scientific evidence to suggest the vaccine causes infertility. In addition, infertility is not known to occur from natural COVID-19 infection, further indicating that immune responses to the virus, whether induced by infection or a vaccine, are not a cause of infertility.

Q: How did COVID-19 vaccines get approved so quickly? Are they safe?

A: Production of the COVID-19 vaccines began sooner than is typical. Normally, production starts after a pharmaceutical company completes the development stage for a vaccine, which includes rigorous testing for safety and effectiveness. Every vaccine goes through a series of reviews and approvals by the FDA and the Advisory Committee on Immunization Practices (ACIP), among others. In the case of COVID-19 vaccines, the federal government invested taxpayer dollars to encourage pharmaceutical companies to start production before the development stage completed.

The vaccines are still going through the same rigorous testing for safety and effectiveness, review, and approval process. However, because pharmaceutical companies began manufacturing the vaccine during the clinical trials, they were able to make the vaccines available as soon as they were given an emergency use authorization.

By all accounts, the Pfizer and Moderna vaccines are safe and effective. The recent recommendation for a pause on the Johnson &Johnson vaccine illustrates how seriously Idaho and the rest of the nation takes vaccine safety. Ultimately, vaccines  are the best way to protect yourself and your loved ones from serious illness and hospitalization from COVID-19.

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An Update from DHW Director Dave Jeppesen: Johnson & Johnson Vaccine

The news this week that there have been six reported cases of a rare and severe blood clot in women between the ages of 18 and 48 who have received the Johnson & Johnson vaccine is not the kind of news we welcome, but I am reassured, as I hope you are, that recommending a pause in the use of the vaccine was the right thing to do and helps show that we all take vaccine safety very seriously.

On Tuesday, the Department of Health and Welfare (DHW) issued a press release recommending that Idaho vaccine providers not use the Johnson & Johnson vaccine until more information is available from the Centers for Disease Control and Prevention (CDC). This recommendation was made after receiving information that the CDC and the Food and Drug Administration (FDA) also recommended a pause in the use of that vaccine and are reviewing the data for the six reported cases. All 50 states have made this same recommendation.

On Wednesday, April 14, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) met and did not put forth any formal recommendations during this meeting. Voting members are waiting for additional data for a more robust risk-benefit analysis, and that should be available to them next week. Additional discussion may address restrictions for vaccine use in highest risk populations, possibly by age or gender.

Although this is not news we were expecting, this is exactly what is supposed to happen with any new vaccine or drug or protocol: if there is an unexpected adverse reaction, there is a pause to review the data and then refine recommendations. The safety system in the United States works. The FDA and the CDC made the right decision to temporarily halt the use of this vaccine.

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From DHW Director Dave Jeppesen: I’m Encouraging all Idahoans to Choose to get the COVID-19 Vaccine

I want to encourage you to choose to get your COVID-19 vaccine. Starting Monday, April 5, all Idahoans 16 and older are eligible to get the vaccine through enrolled vaccine providers in Idaho.

You can sign up today at covidvaccine.idaho.gov, and a vaccine provider will call you to schedule your appointment. Thanks to Idaho’s pre-registration system, you don’t have make numerous calls or visit numerous locations to get your vaccine. We will do the work for you.

Choosing to get the COVID-19 vaccine will help keep you from getting COVID-19. It protects you from very serious illness and hospitalization if you do get infected. Choosing to get vaccinated protects the people around you, especially your family members and friends who are at increased risk of getting severe illness from COVID-19. And choosing to get vaccinated is the best shot we have to keep our kids in the classroom, protect jobs, and return to normal.

The COVID-19 vaccines have been carefully evaluated and are safe and effective. On April 1, 100 COVID-19 infections had been reported among fully vaccinated people in Idaho. These infections represent less than 0.5% of the Idahoans who are now fully vaccinated.

To date, more than 298,000 Idahoans (this includes those who work in Idaho) have been fully vaccinated. This number is those people who have received both doses of the Moderna or Pfizer vaccine, or a single dose of the Johnson & Johnson vaccine.

If you have any questions about the COVID-19 vaccine, you can visit our FAQ page which is updated regularly.

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