FDA Authorizes First Single-Shot Vaccine From Johnson & Johnson, Whitmer Weighs In 

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On February 27, the U.S. Food and Drug Administration (FDA) approved Johnson & Johnson’s single-shot COVID-19 vaccine for emergency use, according to a Johnson & Johnson press release.

The country’s first single-shot vaccine is geared to help “fight against” the global pandemic as the country’s cases balloon to 28.6 million positive cases and about 513,000 deaths, according to nationwide reports.

The shot is available on a not-for-profit basis for emergency pandemic use, according to the press release and the shipping of the vaccine will include delivering more than 20 million doses to the U.S. in March.

The vaccine was developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, and is available for individuals 18 years of age and older, the release added.

This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination, the release also stated.

“This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world – all of whom shared a goal of bringing a single-shot vaccine to the public,” said Alex Gorsky, chairman and Chief Executive Officer at Johnson & Johnson in the release. “We will do everything we can to help bring this pandemic to an end, in the United States, and throughout the world.”

“We believe the Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants. A vaccine that protects against COVID-19, especially against the most dire outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems worldwide,” said Paul Stoffels, M.D., vice-chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson in the release. “We look forward to our continued efforts around the world as we collectively aim to change the trajectory of this global pandemic.”

Governor Gretchen Whitmer also released a statement after the FDA granted emergency use authorization of the Johnson & Johnson single-dose COVID-19 Vaccine:

“This scientific breakthrough is terrific news for our families, frontline workers, and small businesses who are eager to get vaccinated and continue our steady return to normalcy. We now have a total of three safe, effective vaccines from Pfizer, Moderna, and Johnson & Johnson,” Whitmer said in a release.

She added that as the vaccine supply continues increasing because of the efforts of President Joe Biden and his administration, she is “confident that we can reach our goal of vaccinating 70% of Michiganders 16 and up at a rate of 50,000 shots per day,” a metric the state has been meeting in recent weeks.

“Our vaccine rollout will continue to focus on our most vulnerable, promote equity, and prioritize our essential workers and older at-risk Michiganders. The addition of this one-and-done vaccine will help us get shots in arms quicker,” she said, adding a call out to the Michigan Legislature to pass the MI COVID Recovery Plan.

“(This is) so we can use the over $5 billion allocated to us in a bipartisan bill to speed up our vaccination efforts and expand testing, tracing, and lab capacity,” she said. “Every day, week, and month that goes by, we get closer to putting this virus behind us, but I want to remind everyone that we must not let our guard down. It will take time to widely distribute the three vaccines, and we must all continue to do our part by wearing a mask, practicing social distancing, and washing our hands frequently.”

Michigan has administered more than two million vaccines, moving the state closer to Governor Whitmer’s goal of equitably vaccinating at least 70% of Michiganders ages 16 and older as soon as possible. As part of these efforts, Michigan is working to administer 50,000 shots per day through Governor Whitmer’s MI COVID Recovery Plan, partnering with private organizations and nontraditional venues to create more opportunities for Michigan residents to receive a vaccine, the release added.

Important Safety Information on the vaccine below:

WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET THE JANSSEN COVID-19 VACCINE?

Tell the vaccination provider about all of your medical conditions, including if you:

· have any allergies

· have a fever

· have a bleeding disorder or are on a blood thinner

· are immunocompromised or are on a medicine that affects your immune system

· are pregnant or plan to become pregnant

· are breastfeeding

· have received another COVID-19 vaccine

WHO SHOULD NOT GET THE JANSSEN COVID-19 VACCINE?

You should not get the Janssen COVID-19 Vaccine if you:

· had a severe allergic reaction to any ingredient of this vaccine.

HOW IS THE JANSSEN COVID-19 VACCINE GIVEN?

The Janssen COVID-19 Vaccine will be given to you as an injection into the muscle. The Janssen COVID-19 Vaccine vaccination schedule is a single dose.

WHAT ARE THE RISKS OF THE JANSSEN COVID-19 VACCINE?

Side effects that have been reported with the Janssen COVID-19 Vaccine include:

· Injection site reactions: pain, redness of the skin, and swelling.

· General side effects: headache, feeling very tired, muscle aches, nausea, fever.

There is a remote chance that the Janssen COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Janssen COVID-19 Vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

· Difficulty breathing

· Swelling of your face and throat

· A fast heartbeat

· A bad rash all over your body

· Dizziness and weakness

These may not be all the possible side effects of the Janssen COVID-19 Vaccine. Serious and unexpected effects may occur. The Janssen COVID-19 Vaccine is still being studied in clinical trials.

WHAT SHOULD I DO ABOUT SIDE EFFECTS?

If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.

Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.

Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include “Janssen COVID-19 Vaccine EUA” in the first line of box #18 of the report form. In addition, you can report side effects to Janssen Biotech, Inc. at 1-800-565-4008.

Learn more at www.janssen.com.

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