U.S. regulators give full approval to Pfizer COVID-19 vaccine
The U.S. gave full approval to Pfizer’s COVID-19 vaccine Monday, potentially boosting public confidence in the shots and instantly opening the way for more universities, companies, and local governments to make vaccinations mandatory. The Pentagon promptly announced it will press ahead with plans to force members of the military to get vaccinated amid the battle against the extra-contagious delta variant. The University of Minnesota likewise said it will require its students to get the shot, as did Louisiana’s major public universities, including LSU, though state law there allows broad exemptions. More than 200 million Pfizer doses have been administered in the U.S. under emergency provisions — and hundreds of millions more worldwide — since December. In going a step further and granting full approval, the Food and Drug Administration cited months of real-world evidence that serious side effects are extremely rare. President Joe Biden said that for those who hesitated to get the vaccine until it received what he dubbed the “gold standard” of FDA approval, “the moment you’ve been waiting for is here.” “Please get vaccinated today,” he said. Pfizer CEO Albert Bourla called the FDA’s action “an important milestone that I think will unlock some of the more skeptical minds.” Pfizer said the U.S. is the first country to grant full approval of its vaccine, in a process that required a 360,000-page application and rigorous inspections. Never before has the FDA has so much evidence to judge a shot’s safety. The formula, jointly developed with Germany’s BioNTech, will be marketed under the brand name Comirnaty. Moderna has also applied to the FDA for full approval of its vaccine. Johnson & Johnson, maker of the third option in the U.S., said it hopes to do so later this year. Just over half of the U.S. population is fully vaccinated. Vaccinations in this country bottomed out in July at an average of about a half-million shots per day, down from a peak of 3.4 million a day in mid-April. As the delta variant fills hospital beds, shots are on the rise again, with a million a day given Thursday, Friday, and Saturday. Full approval of Pfizer’s COVID-19 vaccine means it meets the same “very high standards required of all the approved vaccines we rely on every day,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. That should help “anyone who still has concerns gain confidence” in the shots. Earlier this month, Defense Secretary Lloyd Austin said he would seek the president’s OK to make the vaccine mandatory by mid-September or once the FDA grants final approval, whichever comes first. On Monday, after the FDA acted, the Pentagon said guidance on vaccinations will be worked out, and a timeline will be provided in the coming days. The approval also opened the way for swift action by colleges to require vaccines and solidified the legal ground for hundreds of universities that have already issued mandates for students and staff. The public university systems in Louisiana and Minnesota had been waiting for FDA action before making vaccinations mandatory. Louisiana has become a COVID-19 hot spot, repeatedly breaking records for the number of people hospitalized with the virus. But certain other states forbid universities to require shots, including Texas and Florida. “Mandating becomes much easier when you have full approval,” said Dr. Carlos del Rio of Emory University. “I think a lot of businesses have been waiting for it.” On the same day the FDA decision came down, New York City announced that all public school teachers and other staffers will have to get vaccinated. The delta variant has sent cases, deaths, and hospitalizations soaring in recent weeks in the U.S., erasing months of progress. Deaths are running at about 1,000 a day on average for the first time since mid-March, and new cases are averaging 147,000 a day, a level last seen at the end of January. Elizabeth Nichols, 18, of Akron, Ohio, said she felt “a rush of relief” after hearing the news of the FDA’s approval. She already was on her way to get her first vaccine shot Monday morning after months of hesitation. “I had an internal battle of whether I should get the shot or not,” Nichols said in an email. “It can be scary subjecting yourself to something that is unapproved.” But she added: “The authorization proves how safe it is.” The FDA, like regulators in Europe and much of the rest of the world, initially allowed emergency use of Pfizer’s vaccine based on a study that tracked 44,000 people 16 and older for at least two months — the time period when serious side effects typically arise. That’s shorter than the six months of safety data normally required for full approval. So Pfizer kept that study going, and the FDA also examined real-world safety evidence. Pfizer’s shot will continue to be dispensed to 12- to 15-year-olds under an emergency use authorization until the company files its application for full approval. Normally, doctors can prescribe FDA-approved products for other reasons than their original use. But FDA’s acting Commissioner Dr. Janet Woodcock strongly warned that the Pfizer vaccine should not be used “off-label” for children under 12 — a warning echoed by the American Academy of Pediatrics. Both Pfizer and Moderna have vaccine studies underway in youngsters, and they are using lower doses than those available for people 12 and older. Pfizer’s Bourla said he expects study results from 5- to 11-year-olds by the end of September, but data for those younger than 5 will take a couple of months. Also, Woodcock said health providers are offering COVID-19 vaccines under agreements with the government that should preclude using Monday’s approval as a pretext for offering booster shots to the general population. Currently, the FDA has authorized third doses of either Pfizer’s or Moderna’s vaccine only for certain people with severely weakened immune systems, such as organ transplant recipients. For everyone else, the Biden administration is planning for boosters starting in the fall. But the
Poll shows Kay Ivey in run-off range as approval drops
For the first time, Gov. Kay Ivey has dropped below 50% in her race for re-election May 24. In a matchup of possible candidates, Ivey now has only 41.5%, well below the threshold to win without a runoff at 50% plus one vote. Incumbents below 50% are considered vulnerable. The independent poll was conducted by Montgomery-based Cygnal August 17-18 among 600 likely Republican primary voters. It has a margin of error of +/- 4.0%. It was paid for by Alabama Daily News. Undecided voters scored 34%. Having had an opportunity to pick the incumbent. The undecideds did not and are generally considered to be prospects to support a challenger. The Republican primary is May 24, 2022, nine months away. The candidate qualifying deadline is January 28, some five months away. Scoring second place was State Auditor Jim Zeigler, who filed an official gubernatorial fund-raising committee with the Secretary of State this month. He has started an ‘exploratory campaign’ and says he will announce a decision when he “can raise enough funds to get the message out.” Other candidates include Tim James, Dean Odle, Christopher Countrymen, and Stacy Lee George. Zeigler says his message is “Zeigler and the Taxpayers vs. Ivey and the Insiders.” He says his strategy is “to get into a runoff against Gov. Ivey.” The Cygnal poll indicates the probability of that situation developing, with Ivey now falling below 50% and Zeigler in a clear second. Zeigler says the 34% undecided voters “are for anybody but Ivey.” “I intend to target those 34% of dissatisfied voters and add them to the Zeigler column.” The poll results were: Kay Ivey 41.5% Jim Zeigler 8.8% Tim James 3.5% Dean Odle 3.1% Someone else 9.2% Undecided 33.9%
The Atlantic Charter: Optimistic leadership in an uncertain world
Imagine your football team is in the first quarter of a game, a couple of star players are sidelined, and the opponent’s offense seems unstoppable. The score is already 28 – 0 when your head coach takes a time-out. He lets his assistants coach up the team while he meets with an architect to design a new stadium to display championship trophies and meets with another head coach to discuss developing a new conference with more efficient rules to increase attendance and enthusiasm for the game. Sound farfetched? Eighty years ago, something like this actually happened – but not on the gridiron. In August 1941, World War II was almost two years old. While Britain was still in the game, her prospects for success were far from certain, with no feeling of inevitable victory. Good news on the battlefront was hard to come by, but inspired by Winston Churchill, the English people continued to maintain the stiff upper lip of optimism. President Franklin Roosevelt couldn’t know that Pearl Harbor was four months away, and American ambivalence about the war in Europe was high. Nevertheless, Roosevelt understood the dangerous world situation and the probable and unavoidable entry of the United States into the conflict. For the first time since Winston Churchill had become prime minister and Roosevelt had become president, these two leaders meet at Placentia Bay, Newfoundland, to discuss the future not only for their respective countries but also for the world.After a series of agenda-less meeting, not only between the two leaders but also among their staffs, they issued a remarkable statement that was later dubbed “The Atlantic Charter.” Perhaps one of the most interesting things about this communique is that it was never really reduced to writing and signed by each country. In fact, it was never ratified by Congress or approved by Parliament. Rather, it was an eight-point idealistic explanation of a post-war agenda to outline to the world at large what the fighting was all about and to anticipate an Allied victory. In 1941 with so many unknowns, the Atlantic Charter expressed an optimism that victory was in sight and gave hope to the nations involved in the conflict. Neither breath-taking hubris nor propaganda ploy, the Atlantic Charter expressed a manifest destiny that the English-speaking people would achieve victory and build a new world based on a unique English worldview. In a nutshell, the Atlantic Charter made it clear that the British and Americans were united against the aggression of the Axis powers. While the United States had not entered the war, the Charter affirmed a solidarity between the two countries and set the stage for American dominance as a world power. The Charter further presented a view that relationships between nation-states would be founded on reciprocal trade agreements emphasizing open markets on equal terms for both the victor and vanquished. This stood in stark contrast to the unfavorable trade arrangements that punished Germany after World War I and precipitated Adolph Hitler’s rise to power. One new principle – perhaps the most controversial – was the right of all peoples to self-determination. This concept was the logical conclusion that since Britain and the United States did not have territorial ambitions and would not support nations using armed conflict to expand their borders, something must happen to nations overrun by the Axis blitz. The clear implication, probably unintended, was that after the war, people within a defined boundary could choose their government, effectively ending colonialism and establishing new countries based on the consent of the governed. The basic tenants of the Atlantic Charter were presented to other Allied nations and generally adopted in principle. The contents were printed on leaflets and dropped over Germany to repudiate the propaganda of any punitive post-war settlement. In Japan, the Charter bolstered anti-American sentiment and was used to show a conspiracy against the insecure nation. Natives under the thumb of colonial powers believed the Charter promoted their rights to independence, thus emboldening a commitment to the Allied cause. One of the most striking features of the Charter was its impact despite having no authority or force of law from ratification by any government. Rather, the Charter was an agreement between two leaders of substantial stature in the world. Its binding impact was a reflection of personal leadership and integrity, indicating that if these two giants made a statement about their goals for a future world order, their credibility gave other countries confidence that the Charter would be implemented. Only great leaders can do things like this. Powerful personalities and bold initiatives characterized both men. In fact, the year before the Atlantic Charter, Roosevelt and Canada’s Prime Minister, Mackenzie King, would complete the Ogdensburg Agreement, which established a mutual defense agreement between the neighboring countries. Like the Atlantic Charter, this agreement was never ratified by any political body but expressed a mutual agreement between strong leaders protecting their countries. To this day, the Ogdensburg Agreement serves as an expression of the mutual defense of Canada and the United States. The Atlantic Charter galvanized the Allies by outlining post-war aims. Its expressed objectives for creating a stable world order were reflected in the creation of the United Nations, but the collective security of that body was thwarted by Soviet ideology, which eschewed any sense of international cooperation and fairness. The Atlantic Charter achieved its near-term objectives by precisely outlining why the allies were committed to the fight. In the long term, it failed to create a structure for nation-states to live in harmony without the threat of territorial ambitions of a neighbor. International organizations work best by providing a loose framework that exalts private property rights and promotes the rule of law. The Atlantic Charter assumed this, but the United Nations became a pawn for the Russians who used principles like self-determination to obtain control over misguided revolutionaries by convincing them communism and not democracy was a counterweight to colonialism. Will Sellers is a 1985 graduate of Hillsdale College and an Associate
Alabama unemployment rate remains below national numbers
Alabama’s unemployment rate for July remains well below the national rate, Gov. Kay Ivey said. The preliminary, seasonally adjusted July rate is 3.2%. That’s down from June’s rate of 3.3% and well below July 2020′s rate of 7.4%, Ivey and state Department of Labor Secretary Fitzgerald Washington said in a news release. The July national rate was 5.4%. Alabama’s July rate represents 71,627 people unemployed, compared to 73,769 in June and 165,510 in July 2020. “Each month we edge closer and closer to our pre-pandemic unemployment rate,” Ivey said. “Employers have added over 73,000 jobs in the past year, and nearly 83,000 more people are working today than they were last year. Industries that were hit the hardest are seeing employment numbers increase monthly. We’ll keep working as hard as we can to continue this remarkable progress.” Counties with the lowest unemployment rates are Shelby County at 2.1%, Blount County at 2.2%, and Cullman and Marshall Counties at 2.3%. Counties with the highest unemployment rates are Wilcox County at 11.2%, Lowndes County at 9.7%, and Perry County at 9.4%. Major cities with the lowest unemployment rates are Homewood at 1.8%, Vestavia Hills at 2.1%, and Hoover and Madison at 2.2%. Major cities with the highest unemployment rates are Selma at 9.4%, Prichard at 8.1%, and Anniston at 6.2%. Washington said the state is continuing efforts to connect employers and job seekers through local and regional job fairs. “These collaborative community events are targeting industry sectors that still need employees and job seekers looking for new or better opportunities,” Washington said. “Those sectors, along with wages, are hitting new record highs. The average weekly wage for the private sector was up a whopping $64.16 over the year.” Total private average weekly earnings measured $986.29 in July, a new record high. That’s a yearly increase of $64.16 and a monthly increase of $20.46, officials said. Additionally, the leisure and hospitality sector hit a new record high, with weekly wages rising to $402.98, up $51.56 over the year, and $13.37 over the month. Republished with the permission of the Associated Press.
Thad McClammy, 78, dies of natural causes
An Alabama state representative died Saturday of natural causes, the House of Representatives said in a news release. State Rep Thad McClammy, a Democrat from Montgomery, died of natural causes, the statement said. He was 78. McClammy was first elected to the Alabama House of Representatives in 1994 to represent District 76, which includes east, south, and western sections of the city of Montgomery. A graduate of both Alabama State University and Auburn University at Montgomery, he was a real estate broker and developer. “The people of District 76 have lost not only their champion in the House but also a very fine man, and I’ve lost a friend,” House Speaker Mac McCutcheon, R-Monrovia, said. “I was honored to serve with Thad and watched how he took care of the people in his district every day. My wife Deb and I send our heartfelt condolences to his family.” Gov. Kay Ivey ordered flags lowered in honor of McClammy. “Thad was a great man and loyal Democrat who served his constituents well. We express our deepest condolences to his family and friends. He will be truly missed,” the Alabama Democratic Party said in a statement. McClammy was chairman of the Montgomery County Legislation Committee and served as the ranking minority member on the House Judiciary Committee and the House Military and Veterans’ Affairs Committee. He also served on the House Financial Services Committee. McClammy was always gracious and solution-oriented, said Republican Rep. Steve Clouse, who was elected to the House the same year as McClammy. “He was just a great guy, he was always very friendly and tried to find a solution and not be divisive,” Clouse said. Funeral arrangements are pending. Republished with the permission of the Associated Press.
Kay Ivey urges Alabama football fans to get vaccinated
Alabama Gov. Kay Ivey is urging college football fans to get vaccinated before heading to stadiums this season. College football kicks off in a few weeks, raising concerns that crowded stadiums could help spread the coronavirus. Asked about those concerns this week, the Republican governor said the remedy is for more people to get vaccinated. “If everybody would just get the vaccine, we wouldn’t have a problem. Simply get the shot, then go enjoy your football game,” Ivey told reporters after participating in an event with college mascots on the steps of the Alabama Capitol. Dr. Scott Harris, Alabama’s state health officer, said the state Department of Public has issued guidance on sporting events, including recommending spacing and emphasizing the importance of vaccinations. “Outdoor events are safer in general than indoor events, but having hundreds of thousands of people getting together during a pandemic is going to result in some disease transmission,” Harris said. “We hope people are vaccinated enough that that can be minimized.” Alabama has one of the lowest vaccination rates in the U.S., with 34.6% of the population fully vaccinated. The state has seen a recent surge in COVID-19 cases, hospitalizations, and deaths that medical officials have attributed to the highly contagious delta variant and the state’s low vaccination rate. Alabama coach Nick Saban has also been an outspoken advocate for getting vaccinated and participated in a public service announcement over the summer encouraging Alabamians to please “get your COVID-19 vaccine.” Saban, earlier this month, again urged people to get vaccinated. “We’re hopeful that we’ll be able to have full capacity in the stadium,” he said. “I’m hopeful that more and more people will get vaccinated so they’ll have the opportunity to do that. But that’s everybody’s personal choice.” Republished with the permission of the Associated Press.
