BioNTech Archives - Baller Alert https://balleralert.com Entertainment & Lifestyle Sat, 19 Dec 2020 21:51:52 +0000 en hourly 1 https://wordpress.org/?v=7.0.2 https://balleralert.com/wp-content/uploads/2020/09/cropped-ba-logo-small-32x32.jpg BioNTech Archives - Baller Alert https://balleralert.com 32 32 FDA Endorses Moderna’s Covid-19 Vaccine; Doses To Be Shipped Around The Nation By This Weekend If Approved https://balleralert.com/fda-endorses-modernas-covid-19-vaccine-doses-to-be-shipped-around-the-nation-by-this-weekend-if-approved/ https://balleralert.com/fda-endorses-modernas-covid-19-vaccine-doses-to-be-shipped-around-the-nation-by-this-weekend-if-approved/#respond Sat, 19 Dec 2020 21:51:52 +0000 https://balleralert.com/?p=157405 The U.S. Food and Drug Administration has endorsed Moderna’s Covid-19 vaccine. On Thursday, Moderna’s coronavirus vaccine moved forward in its journey to authorized, as the FDA after officials voted 20 […]

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FDA Endorses Moderna’s Covid-19 Vaccine; Doses To Be Shipped Around The Nation By This Weekend If Approved

The U.S. Food and Drug Administration has endorsed Moderna’s Covid-19 vaccine.

On Thursday, Moderna’s coronavirus vaccine moved forward in its journey to authorized, as the FDA after officials voted 20 to 1 in favor of the vaccine being authorized for emergency use. The FDA is expected to make its formal decision on Friday, as the country hit a new record of 3,611 deaths on Wednesday. If approved, nearly 5.9 million doses will be shipped around the country beginning this weekend. 

Moderna will join Pfizer and its German partner BioNTech as the latest company to be allowed to begin inoculating the public. Pfizer and BioNTech’s vaccine was authorized for vaccine distribution last week, The New York Times reports. 

Moderna’s vaccine can be distributed more widely because it can be stored at normal freezer temperatures. Pfizer-BioNTech’s vaccine does not require an above-average cold storage environment. Moderna’s vaccine will also work well for hospitals in less populated areas because it comes in smaller batches to use quickly. 

“Moderna can go to more places,” Dr. Mandy Cohen, North Carolina’s secretary of health and human services, said this week. “We hope to be in all 100 counties with some amount of vaccine — small allocations at first — by the end of next week, assuming Moderna gets approved this week and we get our allocations delivered over the course of next week.”

A group of experts will come together on Saturday to decide if the Center for Disease Control and Prevention should allow the distribution of the Moderna vaccine. On Sunday, that same panel of experts will decide which “priority group” should be next in line for the vaccine, The New York Times reports. 

 

COVID 19 VACCINE
COVID 19 VACCINE
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FDA Says Pfizer-BioNTech Vaccine Meets Prescribed Success Criteria https://balleralert.com/fda-says-pfizer-biontech-vaccine-meets-prescribed-success-criteria/ https://balleralert.com/fda-says-pfizer-biontech-vaccine-meets-prescribed-success-criteria/#respond Tue, 08 Dec 2020 21:13:52 +0000 https://balleralert.com/?p=155904 In a detailed analysis, the Food and Drug Administration said that Pfizer and partner BioNTech vaccine “met the prescribed success criteria.” This is a step forward for the vaccine to […]

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FDA Says Pfizer-BioNTech Vaccine Meets Prescribed Success Criteria

In a detailed analysis, the Food and Drug Administration said that Pfizer and partner BioNTech vaccine “met the prescribed success criteria.” This is a step forward for the vaccine to be approved for distribution. The vaccine is expected to be distributed as early as this weekend.

The detailed analysis highlighted the vaccine’s benefits, stating that the vaccine reduces the risk of contracting the virus. The vaccine has greater side effects than the placebo – headaches, muscle pain, joint pain, injection site reactions, chills, and fever.

Panelist criticized the trial’s demographics, saying that the trial wasn’t offered to a diverse group of people. Over 80% of the almost 38,000 participants were white. 162 people received a placebo, and eight received the vaccine, 146 of them were white. The vaccine was 100% effective in Black people, with seven people in the placebo group and none having the vaccine.

A vaccine researcher at John Hopkins University, Dr. Anna Durbin, said that the vaccine offers some protection 10 days after the first dose.

“You may get protection earlier than we were anticipating,” she said.

Dr. Durbin said she would love to see more Black people participate in the research.

“There’s a lot of distrust in the [Black] community around research in general,” she said.

Six participants for the vaccine died during the trial, two received the vaccine, and four received the placebo. Investigators did not address the deaths.

Pfizer says that the vaccine is 95% effective at protecting against symptomatic COVID-19.

According to The Wall Street Journal, federal officials estimate that U.S. vaccine deliveries will be enough for around 20 million people.

 

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Pfizer and BioNTech Will Submit Emergency Use Authorization For COVID-19 Vaccine https://balleralert.com/pfizer-and-biontech-will-submit-emergency-use-authorization-for-covid-19-vaccine/ https://balleralert.com/pfizer-and-biontech-will-submit-emergency-use-authorization-for-covid-19-vaccine/#respond Fri, 20 Nov 2020 18:01:14 +0000 https://balleralert.com/?p=153317 Pfizer and BioNTech will submit an emergency use authorization for their COVID-19 vaccine today. Earlier this week, the companies reported that the vaccine was 95% effective. The emergency use authorization […]

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Pfizer and BioNTech Will Submit Emergency Use Authorization For COVID-19 Vaccine

Pfizer and BioNTech will submit an emergency use authorization for their COVID-19 vaccine today. Earlier this week, the companies reported that the vaccine was 95% effective. The emergency use authorization will be requested in the United States, Australia, Canada, Europe, Japan, and the United Kingdom.

The Food and Drug administration’s emergency authorization program allows companies to seek early approval when certain standards are met. The FDA requires supporting information and safety data for approval.

Pfizer and BioNTech vaccine recently entered a phase 3 clinical trial with 43,661 participants. The company is submitting data from participants, including safety information and supplementary data.

“Our work to deliver a safe and effective vaccine has never been more urgent,” Albert Bourla, Pfizer CEO, said in a statement.

COVid Vaccine
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