Tag: Johnson and Johnson COVID-19 vaccine

U.S. lifts pause on Johnson & Johnson’s coronavirus vaccine

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The CDC and FDA on Friday lifted the recommended pause on use of Johnson & Johnson’s coronavirus vaccine, saying the benefits of the shot outweigh the risk of a rare blood clot disorder. 

Why it matters: The move clears the way for states to resume administering the one-shot vaccine.

  • The Johnson & Johnson shot had been seen as an important tool to fill gaps in the U.S. vaccination effort. But between the pause in its use and repeated manufacturing problems, its role in that effort is shrinking. Continue reading.

White House faces new obstacles in COVID-19 fight

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President Biden is facing a series of fresh obstacles in getting the coronavirus pandemic under control in the United States.

Several states have seen an uptick in cases even as millions of Americans are vaccinated each day, which can be attributed in part to the lifting of restrictions on masks and businesses and general pandemic fatigue more than a year after the virus began to spread widely. More contagious variants are spreading throughout the country, and experts warn that new variants could pop up until the country reaches a greater degree of immunity.

The Food and Drug Administration (FDA) recommended a pause in the use of the Johnson & Johnson vaccine this week. While many health experts praised it as the right move, an extended pause could drive up vaccine hesitancy, posing yet another challenge for Biden. Continue reading.

Johnson & Johnson vaccine suspension – a doctor explains what this means for you

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A panel of experts met on April 14, 2021, to review evidence on blood clots that have been reported in seven people after they received the one-dose Johnson & Johnson COVID-19 vaccine. The panel, the Advisory Committee on Immunization Practices, or ACIP, advises the Centers for Disease Control and Prevention on immunization. It delayed voting on a recommendation to the CDC so that members can further evaluate risk and data. The clotting, which resulted in one woman’s death, led the CDC and FDA on April 13, 2021, to pause use of the J&J vaccine. Dr. William Petri, an infectious disease physician and immunologist at the University of Virginia School of Medicine, answers questions to help put this development in context.

What is this potential side effect of the J&J vaccine for COVID-19?

The potential side effect is a blood clot in the veins that drain blood from the brain. This is called central venous sinus thrombosis. In the vaccine-associated cases of this, platelets in blood, which are important for making clots, have been lower than normal. This same side effect has been seen in the AstraZeneca COVID-19 vaccine that also uses an adenovirus to deliver the coronavirus spike glycoprotein. In the case of the AstraZeneca vaccine, the clotting disorder has been linked to antibodies against platelet factor 4 (PF4) that are apparently induced by the adenovirus backbone of the vaccine. This antibody causes the clotting disorder by activating platelets to clot. 

Continue reading “Johnson & Johnson vaccine suspension – a doctor explains what this means for you”

Johnson & Johnson under pressure to deliver promised vaccine doses to states

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Delays could undercut vaccinations in areas lacking access to deep freezers needed for one of the other authorized COVID-19 vaccines

Johnson & Johnson is under pressure to deliver its promised 20 million vaccine doses by next week, as several state public health officials indicate they are receiving few or no shots this week and have no idea how much they’ll get later.

The uncertainty comes at a time when the demand for vaccines continues to overwhelm supply, a weary country braces for the spread of viral variants and hundreds of people die from COVID-19 each day. It raises questions about how successful the company was in meeting a central goal of the massive U.S. investment in vaccine development: to manufacture sufficient supplies of shots before they were proven effective in order to hit the ground running. 

The delays could undercut vaccinations in rural and low-income areas without access to deep freezers needed for one of the two other authorized vaccines. Johnson & Johnson’s single-dose shot is helpful in those places since it’s durable for three months in the refrigerator. Continue reading.

First doses of new COVID-19 vaccine arrive in Minnesota

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State expects to get 42,500 doses of the Johnson & Johnson vaccine this week 

The first doses of the new Johnson & Johnson COVID-19 vaccine arrived in Minnesota on Wednesday, just days after receiving federal regulatory approvals.

An M Health Fairview facility in southeast Minneapolis took possession of 980 vials, enough to vaccinate 4,900 people.

Other health care providers in the state, including Essentia Health in Duluth, received the vaccine Wednesday as part of a shipment of 42,500 doses coming to Minnesota this week. Continue reading.

CDC panel endorses emergency use of Johnson & Johnson vaccine

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A Centers for Disease Control and Prevention (CDC) advisory committee has voted to recommend Johnson & Johnson’s COVID-19 vaccine for emergency use for people ages 18 and older in the United States.

CDC Director Rochelle Walensky is expected to accept the committee’s recommendation later Sunday or Monday, allowing vaccinations to begin.

The 12-0 vote with one recusal from CDC’s Advisory Committee on Immunization Practices comes after the Food and Drug Administration officially cleared the country’s third coronavirus vaccine for emergency use on Saturday. Continue reading.

FDA authorizes Johnson & Johnson’s one-shot COVID-19 vaccine for emergency use

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The Food and Drug Administration on Saturday issued an emergency use authorization for Johnson & Johnson’s one-shot coronavirus vaccine.

Why it matters: The authorization of a third coronavirus vaccine in the U.S. will help speed up the vaccine rollout across the country, especially since the J&J shot only requires one dose as opposed to Moderna and Pfizer-BioNTech’s two-shot vaccines. 

  • Unlike Moderna and Pfizer-BioNTech’s shots, the J&J vaccine can also be stored at refrigerator temperatures for three months, making it easier to transport. 
  • White House coronavirus coordinator Jeff Zients said on Wednesday that J&J will have 3 million to 4 million doses ready for distribution. Continue reading.

FDA panel endorses Johnson & Johnson COVID vaccine

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A Food and Drug Administration (FDA) advisory panel on Friday endorsed Johnson & Johnson’s coronavirus vaccine and recommended the agency grant emergency authorization, moving the nation’s third vaccine one step closer to getting into Americans’ arms.

The panel voted 22-0 that the benefits outweigh the risks for adults age 18 and older. 

FDA could give the green light to the single-dose vaccine as early as Saturday. Continue reading.

FDA analysis finds Johnson & Johnson COVID vaccine is safe and effective

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The Food and Drug Administration’s staff released a briefing document on Wednesday endorsing Johnson & Johnson’s one-shot coronavirus vaccine as safe and effective.

What’s next: An FDA advisory panel will meet Friday to review the briefing document and vote on whether to recommend an emergency use authorization (EUA). The FDA could then issue the (EUA) as soon as this weekend, clearing the way for distribution in the U.S. to begin.

Details: The shot was found to be 66.9% effective against moderate to severe/critical COVID-19 cases 14 days after vaccination, and 66.1% effective after 28 days. Against severe/critical cases, the vaccine was 76.6% effective after 14 days and 85.4% effective after 28 days. Continue reading.