According to multiple reports, pharmaceutical company Moderna plans to submit its COVID-19 vaccine to the FDA for emergency approval Monday after fulfilling the required set of clinical trials and has announced that it has been told that the agency is meeting to discuss approval for the vaccine on Dec. 17, setting up the possibility that another form of the vaccine could be distributed before the end of 2020.
Moderna will become the second company to submit a vaccine to U.S. regulators for approval after Pfizer and BioNTech submitted their vaccine to the FDA for emergency approval on Nov. 20. According to Moderna, its vaccine has a 94% overall effectiveness rate, which is similar to the effectiveness rate for Pfizer’s vaccine, according to clinical trials.
However, the makers of Moderna claim that their vaccine is 100% effective at preventing “severe” forms of the coronavirus. Moderna also claims that their vaccine is significantly easier to store than Pfizer’s, which might make mass distribution of the vaccine easier.
If the FDA approves Moderna’s application, it will be the first vaccine brought to market by the pharmaceutical company.
The company claims that no serious safety concerns were identified during the clinical trials and that side effects were mild and limited to “injection site pain, headaches and fatigue.”
Moderna’s vaccine will require two doses to be effective, and the company says that it has plans for 20 million doses — enough to inoculate 10 million people — by the end of 2020. The company’s goal is to manufacture between 500 million and one billion doses in 2021.
Pfizer, meanwhile, has promised that it will have doses for up to 25 million people ready to ship by the end of the year, meaning that 35 million people in America could potentially receive the vaccine this year. It does seem clear, however, that the pharmaceutical companies will likely struggle to ramp up production in 2021 to an extent large enough to ensure that the global population is adequately served in 2021.
Author: Leon Wolf
Source: The Blaze: Moderna to submit coronavirus vaccine to FDA for approval today, expects decision in December
The Presidential campaign for President Donald Trump notched another legal victory in Pennsylvania, securing an order requiring Pennsylvania election officials to set aside certain ballots that are lacking some voter information and not include them in the final tally until litigation concerning them can be resolved.
The ruling comes in response to one of the lawsuits filed by the Trump campaign earlier this week, which sought to have certain mail-in ballots that lacked certain voter identification information thrown out. The judge has not yet ruled on the campaign’s lawsuit, but did agree in an order released Thursday afternoon to segregate the contested ballots and keep them from being counted in the official tally until the litigation is resolved.
The Trump campaign hopes that this will help prevent former Vice President Joe Biden from taking a lead in the first count of ballots, which would make their battle significantly more difficult from a political and public relations standpoint.
The number of ballots currently expected to be affected by the order is almost certain to be relatively small, and would likely not matter unless the final margin in Pennsylvania is 10,000 votes or less. The Trump campaign, meanwhile, remains hopeful that the race will, indeed, be close enough for this ruling to matter in the final analysis.
This litigation is separate from the lawsuit concerning the vote count in Philly, in which the campaign scored yet another victory on Thursday, securing an order that theoretically allows them to observe counting in Philadelphia from close range. The campaign had complained that their observer was kept over 100 feet away from some of the counting tables, which prevented them from verifying that ballots that were being counted were in conformity with the law. However, Trump campaign operative Corey Lewandowski has complained that that the Trump campaign is not being given the access they are supposed to have pursuant to the order.
Author: Leon Wolf
Source: The Blaze: Trump campaign wins another battle in Pennsylvania court; certain ballots lacking some voter information will not be counted for now
The culture continues to shift
Netflix has announced that it plans to allow a 9-year-old transgender child at the center of a bathroom controversy in Texas to star in its upcoming series, “The Baby-Sitters Club,” and that the character played by the child will also be transgender.
The child, who was born male and named Joseph but who now identifies as female and goes by the name Kai Shappley, was at the center of a legal fight back in 2016. When he was just a kindergartner, Shappley’s parents insisted that in spite of the fact that he was just 5 years old, he was actually trans and should be permitted to use the girls’ restroom. Shappley’s mother said at the time that her child had claimed to be a girl since the time he was 2 or 3 years old.
The Pearland, Texas, Independent School District offered to allow Shappley to use private, gender-neutral restrooms, which were located in each kindergarten room on the school’s campus, but Shappley’s mother insisted that the child should be allowed to use the girls’ restroom. When the school district refused, Shappley’s mother moved the family nearer to Austin in order to hopefully find a more pliant school district.
Now, the younger Shappley will be playing the character of “Bailey” — a trans female character — on the upcoming Netflix show. According to KPRC-TV, Shappley’s mother said, “I got a Facebook message from someone in LA that there was a spot for a trans girl on The Babysitter’s Club and they asked if she wanted to play the part of Bailey.” The family then flew to Vancouver, Canada, a week later for filming.
Shappley has already been the subject of a documentary produced by the ACLU called “Trans in America: Texas Strong,” and also hopes to have other future acting opportunities. According to KPRC, Shappley is already involved in another filming project.
Author: Leon Wolf
Source: The Blaze: Netflix show will feature transgender character who is 9 years old
Democrats condemn the investigation as a partisan gimmick
The Senate Homeland Security and Governmental Affairs Committee voted Wednesday to authorize Chairman Ron Johnson (R-Wis.) to issue subpoenas to Blue Star Strategies in connection with an investigation into Hunter Biden’s dealings with Ukrainian energy company Burisma Holdings.
The investigation into the presumptive Democratic nominee’s son came about as the result of the Democrats’ attempt to impeach President Donald Trump. The Democratic investigation conducted by the House along party lines sought to remove the president from office on the basis that he allegedly pressured the Ukrainian government into investigating Hunter Biden.
During the course of that investigation, it was revealed that former Vice President Joe Biden’s son Hunter had been paid a $50,000 a month salary by Burisma despite having no obvious expertise in the natural gas industry.
Since the impeachment investigation, Republicans in the Senate have sought to investigate whether Blue Star Strategies, a public relations firm retained by Burisma, sought to leverage Hunter Biden’s position on Burisma’s board to influence policymakers in the Obama State Department.
Democrats have condemned the investigation as a partisan gimmick and all Democrats on the committee voted against authorizing the subpoena, which seeks documents and a deposition from Blue Star Strategies CEO Karen Tramontano.
According to Politico, Johnson responded to Democratic objections by asking, “What is everybody worried about? If there’s nothing there, we’ll find out there’s nothing there. But if there’s something there, the American people need to know that.”
Former Vice President Joe Biden has denied any wrongdoing by himself or his son Hunter in connection with Burisma.
Author: Leon Wolf
Source: The Blaze: Senate committee votes to authorize subpoenas in Hunter Biden investigation