Healthcare
Pfizer announces trial results show vaccine is effective for children ages 5-11
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Pfizer released the results of their nine-month study on COVID-vaccinated children ages five to eleven. According to the trial, the vaccine showed a “favorable safety profile and robust neutralizing antibody responses” in young children.
First, 2,268 children were chosen as Pfizer’s subjects. All were given two doses of 10 µg 21 days apart. This is a third of the amount given to children and adults over sixteen years old.
“The 10 µg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age,” Pfizer’s statement read.
Then, Chairman and Chief Executive Officer Albert Bourla lauded the study’s success. “Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” Bourla said in the same statement. “Since July, pediatric cases of COVID-19 have risen by about 240% in the U.S. – underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children five to eleven years old, and we plan to submit them to the FDA and other regulators with urgency.”
However, this comes three days after the Center for Disease Control and Prevention’s study on the vaccine’s effectiveness. As a result, the CDC reported the Pfizer vaccine is 5% less effective than Moderna’s. Yet, Pfizer is still 88% effective.
Next, the company anticipates to release the results of studies on children younger than five by the end of the year.
You can follow Jenny Goldsberry on Twitter @jennyjournalism.
Earlier this week the United States Food and Drug Administration (FDA) announced it will be working to import chemotherapy drugs from, of all places, China. The drug, called Cisplatin, is to help “ramp up supply amidst rampant drug shortages in the U.S.” reports Foreign Desk News.
Foreign Desk News writes:
Cisplatin comes from drugmaker Qilu Pharmaceutical, which is marketed and produced in China but has not been approved by the FDA. According to a May 24 letter, Qilu will work with the Canadian-based drug company Apotex to import and distribute the medication, which will come in 50-milligram vials with Chinese labels.
“The FDA is responding to yet another generic drug shortage,” said Edmund F. Haislmaier, an expert in healthcare policy and markets at The Heritage Foundation. “The underlying cause of those shortages is that generic drugs have become low-margin commodity products,” he added.
Last week on Twitter, FDA commissioner Dr. Robert Califf said the partnership with Qilu Pharmaceutical is temporary but will provide patients with a potentially life-extending drug.
“The public should rest assured that we will continue all efforts within our authority to help the industry that manufactures and distributes these drugs meet all patient needs for the oncology drugs impacted by shortages,” Califf said.
The public should rest assured that we will continue all efforts within our authority to help the industry that manufactures and distributes these drugs meet all patient needs for the oncology drugs impacted by shortages. https://t.co/8XvOuJzSL4
— Dr. Robert M. Califf (@DrCaliff_FDA) June 3, 2023
Foreign Desk News adds:
The latest move by the FDA is sure to spark concern and debate in Congress, as lawmakers in the House and Senate have called on the Biden administration to de-couple the U.S. economy from the Chinese markets, given Beijing’s aggressive push to expand in the South-China Sea and eventually take over the island state of Taiwan. China has also spread illegal and dangerous synthetic opioids and fentanyl drugs across the U.S. southern border, resulting in the devastating deaths of many Americans.
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