Vaccine by Halloween

Posted on by Thor

Yahoo News reported that, the US could authorize COVID-19 vaccines for younger kids, 5 to 11, by Halloween, Pfizer‘s new timeline suggests. The company expects to submit data to the FDA for this younger age group in early October. Pfizer is testing a lower dose of its vaccine among young kids to avoid unnecessary side effects.

The timeline might be as follows:

  • Late September 2021: Pfizer’s clinical trial will show whether the shots are safe and effective for kids ages 5 to 11.
  • Early October 2021: Pfizer will submit that trial data to the FDA.
  • Late October 2021: The FDA could authorize COVID-19 shots for emergency use among kids ages 5 to 11.
  • Early November 2021: Pfizer will submit trial data for kids between 6 months and 5 years old to the FDA.
  • Late November 2021: The FDA could authorize the shots among kids between 6 months and 5 years old.

    Moderna, meanwhile, expects to have data about its vaccine’s efficacy among young kids later in the fall or early this winter.

    Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN’s Jake Tapper on September 24, 2021 that we might even see the FDA authorize both the Moderna and Pfizer shots for kids before the winter.

    Johnson & Johnson is on a slower timeline. The company won’t start studying its vaccine among children ages 12 to 17 until this fall. If the shot is shown to be safe and effective among older kids, J&J could then start enrolling 2- to 11-year-olds in its trial, followed by children younger than 2. That means a single-dose shot likely won’t be available to kids until sometime in 2022.

Breakthrough Cases

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The CDC has reported 5800 breakthrough cases of COVID-19 out of the nearly 77 million people who have been fully vaccinated. 65 percent of the cases were in women, and just over 40 percent were in people ages 60 and up. About 29% of those experiencing breakthrough infections experienced no symptoms, however, seven percent of people were hospitalized, and 74 people died.

It is unclear why asymptomatic individuals were tested for Covid-19 after being fully vaccinated. It could be that some employers, such as health care systems, require regular testing.

People are considered fully vaccinated two weeks after they receive their second dose of a two-dose vaccine, such as the Pfizer-BioNTech or the Moderna vaccines, or two weeks after a single dose of the Johnson & Johnson vaccine. (Use of the Johnson & Johnson vaccine is currently paused in the U.S. as federal health officials investigate cases of rare blood clots linked to the shots.) In clinical trials, the Pfizer and the Moderna vaccines were found to be around 95 percent effective against Covid-19, and the Johnson & Johnson vaccine was 72 percent effective against moderate-to-severe illness in its U.S. trial.

“I would encourage people to continue, once they’re vaccinated, to use all the prevention measures that we’ve been talking about when they’re outside their home, including masking and distancing and whatnot. And all of that should be active in the workplace,” the CDC’s director, Dr. Rochelle Walensky, said during a briefing for the press on April 12, 2021. These breakthrough cases are another reason that people should continue to wear masks, social distance and wash hands since research is not yet in on weather they could pass the disease on to others.

Vaccination remains critical to ending the pandemic. “It does not reduce the risk to nil, but it does reduce the risk to something that we can handle.”

Johnson & Johnson Blood Clots

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The Food and Drug Administration (FDA) recommended there be a “pause” for the Johnson & Johnson  vaccine after 6 women developed rare brain blood clots after getting the vaccine. One woman died.

The CDC‘s Advisory Committee on Immunization Practices will convene April 14, 2021 for an emergency session, with a vote scheduled on “updated recommendations for use” before the group adjourns at 4:30 p.m. Eastern Time.

Dr. Anthony Fauci, President Joe Biden‘s chief medical adviser, told CBS Evening News, that it appeared that the adverse effect occurred within six to 13 days, and “so if you’ve had it a month or two ago, I think you really don’t need to worry about anything.” He went on to emphasis that the chance of these adverse side effects is “less than 1 in a million,” but he said to be alert to the symptoms such as severe headache, some difficulty in movement — such as in a neurological type of a situation — or some chest discomfort and difficulty breathing.

The cases the FDA and CDC are investigating occurred involved a blood clot called cerebral venous sinus thrombosis, which was seen alongside low levels of blood platelets, according to their statement. All of the six women were between the ages of 18 and 48. “Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given,” they said.

The agencies said the “adverse events” seem to be extremely rare, but that the pause is important so that health care providers can be made aware of the reactions and properly recognize and manage the cases, given the unique treatment required. It has not yet been determined if the vaccine was the direct cause of the blood clotting cases. The AstraZeneca vaccine, used in Europe and not yet available in the USA has also been linked to cases of blood clots. Both the AstraZeneca and the Johnson & Johnson vaccines use an inactivated form of a common cold virus, called an adenovirus, to teach the immune system to recognize the spike protein found of the surface of the coronavirus. Experts believe it’s possible that on rare occasions, the adenovirus itself could lead to clotting, due to a reaction involving platelets.

Regardless this will become a rallying point for any anti vaxers.