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The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee has endorsed Pfizer’s coronavirus vaccine, in a major step toward an epic vaccination campaign that could finally conquer the outbreak. The group, in a 17-4 vote with one abstention, concluded that the shot appears safe and effective against the coronavirus in people 16 and older.The Food and Drug Administration is expected to follow the recommendation issued Thursday by its expert advisers. A final FDA decision is expected within days. The vaccine had already been authorization by officials in Canada and the UK.An emergency use authorization allows practitioners to administer a vaccine despite it not gaining full FDA approval. The EUA means that the vaccine is allowed to be used in non-clinical settings, which would allow Americans not in a trial or hospital setting to get the vaccine.Millions of shots would then ship to begin vaccinating health care workers and nursing home residents, but the Centers for Disease Control and Prevention will need to formally recommend the vaccine before health care officials can begin distributing the shots.Once it is authorized, it is expected that several million doses of the vaccine will immediately begin being distributed throughout the US to high-risk individuals. The first group of those expected to be inoculated includes health care workers and those who live or work in assisted living facilities.“The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. I want to assure the American people that the FDA’s process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and stands ready to do so as soon as a EUA request is submitted. While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible.”Pfizer says that the vaccine is showing a 95% efficacy against coronavirus infection. It is one of two vaccines that could be approved by the FDA in the next few weeks. Moderna also has a vaccine candidate that is showing the efficacy of 95%.“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally. Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.”One concern over the Pfizer vaccine is possible side effects on those prone to allergic reactions. The UK’s National Health Service is advising those prone to allergic reactions to not take the Pfizer vaccine as it investigates two health care workers having apparent reactions after receiving the vaccine.Once given authorization, officials will be forced to confront two challenges: Public confidence in the vaccine and distribution. Both the Moderna and Pfizer vaccines are required to be refrigerated until use, complicating distribution methods.Also, polls are showing that a significant number of Americans are hesitant to take the vaccine. Public health experts say getting the vast majority of Americans immunized is important in order to reach herd immunity against the virus and to allow for normalcy to return to the US.In addition to a number of public health experts saying they’ll get the vaccine as a way to instill trust, former Presidents Bill Clinton, George W. Bush, and Barack Obama said they would publicly take the vaccine in order to instill faith in the shot.Widespread access to the general public is not expected until the spring. 4342

The California NAACP is urging "The Star-Spangled Banner" be removed as the national anthem, according to the Sacramento Bee. The NFL has been embroiled in a national controversy regarding players kneeling for the playing of "The Star-Spangled Banner" before games. President Donald Trump has weighed in multiple times condemning players as being disrespectful for kneeling for the anthem.  413

The Centers for Disease Control and Prevention have given the green light to begin administering the Moderna COVID-19 vaccine to Americans age 18 and older. Inoculations using Moderna’s version of the vaccine could begin Monday morning.Watch HHS and defense officials discuss vaccine distribution:This is the second vaccine to combat the surging coronavirus approved first by the FDA and then the CDC this month.This COVID-19 vaccine was developed by Moderna and the National Institutes of Health, and it can be stored at warmer temperatures than the Pfizer-BioNTech vaccine. Both vaccines have shown to be more than 90% effective.The Moderna vaccine is already being shipped to health care facilities around the country, following a Friday night FDA emergency use authorization.An advisory panel to the CDC voted Saturday to approve the emergency use of the Moderna vaccine, and director of the CDC, Robert Redfield, formally accepted their recommendation Sunday afternoon.In a tweet, the CDC stated they had "accepted the Advisory Committee on Immunization Practices' recommendation for use of the second authorized COVID19 vaccine." 1143

The Food and Drug Administration warned pregnant women on Thursday of using some pain and fever medications during the second half of pregnancies.According to the FDA, these nonsteroidal anti-inflammatory drugs can cause rare but serious kidney problems in the unborn baby, which can cause pregnancy-related complications. Nonsteroidal anti-inflammatory drugs include ibuprofen, naproxen, diclofenac, and celecoxib. The FDA added that its warning does not apply to low-dose aspirin.“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” said Patrizia Cavazzoni, M.D., acting director of FDA’s Center for Drug Evaluation and Research. “To this end, the agency is using its regulatory authority to inform women and their health care providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”The FDA says that warnings on prescription nonsteroidal anti-inflammatory drugs already advise of complications past 30 weeks. The newest guidance calls on health care providers to only prescribe the lowest effective dose for the shortest period possible for women 20 to 30 weeks into their pregnancy.More information on the warning can be found here. 1259

The Centers for Disease Control and Prevention say four people have died and 11 others have been hospitalized after they ingested hand sanitizer.In the report, the CDC said the 15 adults, 13 of which were men, were being treated for methanol poisoning, which occurred in New Mexico and Arizona between May and June.The CDC said three people suffered vision problems."Alcohol-based hand sanitizer products should never be ingested," CDC officials said in the report. "In patients with compatible signs and symptoms or after having swallowed hand sanitizer, prompt evaluation for methanol poisoning is required. Health departments in all states should coordinate with poison centers to identify cases of methanol poisoning."As of July 8, four people were still hospitalized, the report stated."Among the four patients who died, three had seizures at the time of admission; initial signs and symptoms were not reported for the fourth patient," the report said.According to the report, the average age was 43, with some of the incidents happening amongst Native Americans. 1076