Guidance For The Selection And: Fill & Download for Free

'Why doesn't the CDC or WHO offer more seasonal flu candidate vaccine viruses (CVVs)? Given that it takes a long time to grow the vaccine to make a flu shot, why not make several versions and pick the most effective at the time of flu shot injections?'This answer briefly coversThe global seasonal flu vaccine production process: how it starts, the key players, etc.How egg-based flu vaccine production is its major bottleneck.The clock for the Northern Hemisphere annual seasonal flu vaccine starts in February with the WHO, which coordinates the Global Influenza Surveillance and Response System (GISRS), a group of 143 WHO-designated National Influenza Centers (NICs) in 113 WHO Member States plus 6 WHO Influenza Collaborating Centers and several Regulatory and Reference labs.These NICs isolate the viruses presently circulating in their countries/regions and submit them to CCs which conduct detailed antigenic analysis to determine the influenza A and B subtypes.The WHO then makes a worldwide recommendation of the influenza A and B strains to be used for the upcoming season's vaccine, which needs to be adapted to the local epidemiological situation in each country/region.For example, the FDA makes the local decision in the US by selecting the strains to include for that year in the US.See sequentially below text from 1, emphasis mine, and table from 2.'These WHO recommendations provide a guide to national public health and regulatory authorities and vaccine manufacturers for the development and production of influenza vaccines for the next influenza season. In contrast to many other vaccines, the viruses in influenza vaccines have to be evaluated and updated regularly because circulating influenza viruses continuously evolve. Recommendations are made in February/March for the following influenza season in the northern hemisphere and in September for the following influenza season in the southern hemisphere because approximately 6-8 months are needed to produce and approve vaccines. WHO has formulated guidance for countries in tropical and sub-tropical regions to assist them in choosing which vaccine composition (February/March or September) is most appropriate (Seasonal influenza vaccine in tropics and subtropics).'Using eggs to grow seasonal flu vaccine is the major bottleneck in its production (see below from 3).Using eggs to grow seasonal flu vaccine is the major bottleneck in its production (see below from 3).Egg-based flu vaccines have all sorts of drawbacksTake at least 6 months, a length of time that ends up creating other problems.Logistically, vaccine design can't be tweaked on a dime midway and yet sufficient amounts made in time for flu season once the annual process starts.Egg supply can be threatened or inadequate during avian flu epidemics.Currently the decision for which flu strains should be included is made ~9 months before the start of the next flu season to give enough time to produce and distribute the vaccine. This decision is based on an early snapshot which gives a longer window of opportunity for new antigenic variants to emerge among the strains circulating in the human population, the so-called mismatch issue caused by flu virus' prodigious ability to engage in Antigenic drift - Wikipedia.The longer it takes to grow the flu strains inside chicken eggs, the greater the opportunity for flu virus variants to emerge. Often this process-associated limitation is the reason for reduced flu vaccine efficacy.Egg-adapted flu strains can often be antigenically different and thus may end up driving immune responses to such irrelevant antigens rather than to those that are expressed by the circulating flu strains that are infecting humans during a given flu season (4).While such mutation propensity was observed all the way back in 1980 (5), frequent occurrences of low flu vaccine effectiveness in recent years has now made it a front and center issue.Egg-adaption induced mutations in flu strains seem to be especially a problem with H3N2 flu strains (6),which seem prevalent in the 2017-2018 flu season.These types of process-associated artifacts are frequently the reason for low flu vaccine efficacy. So what to do about it? Other approaches to produce seasonal flu vaccine include cell-based, recombinant protein-based or plant based (see below from 7).Problem is such approaches have been discussed and explored for years but none has yet broken through into the mainstream. Reasons for delay include the protracted length and expense for each approach to pass muster, which requires the expensive proposition of undertaking a series of clinical trials that pass the benchmarks for safety and efficacy. While these approaches are being put to the test in this fashion, none is yet close to the finish line.Another is the holy grail of universal flu vaccines (8, 9). Hold up there isIncomplete knowledge of what an effective immune response to flu entails.Which specific immune response elements are both necessary and sufficient.Different studies spotlight different features while what constitutes flu Correlates of immunity/correlates of protection - Wikipedia is still a matter of debate.Thus, notwithstanding its many drawbacks including variable efficacy, given its proven track record of safety, and tried and tested production process, the 70 year old egg-based seasonal flu vaccine unfortunately currently remains a mainstay.Bibliography1. http://www.who.int/influenza/vaccines/virus/candidates_reagents/201703_qanda_recommendation.pdf2. Brooks, W. Abdullah, and Mark C. Steinhoff. "Epidemiology of influenza in tropical and subtropical low-income regions." Influenza vaccines for the future. Springer, Basel, 2011. 55-75. https://the-eye.eu/public/Books/Medical/texts/Influenza%20Vaccines%20for%20the%20Future%202nd%20ed%20-%20R.%20Rappuoli%2C%20et%20al.%2C%20%28Springer%2C%202011%29%20WW.pdf#page=703. http://www.multivu.com/players/English/7842051-sanofi-pasteur-influenza-vaccine/docs/infographic-670594208.pdf4. Raymond, Donald D., et al. "Influenza immunization elicits antibodies specific for an egg-adapted vaccine strain." Nature medicine 22.12 (2016): 1465. https://crystal.harvard.edu/PDFs/raymond_etal.pdf5. Brand, Colin, and Peter Palese. "Sequential passage of influenza virus in embryonated eggs or tissue culture: emergence of mutants." Virology 107.2 (1980): 424-433.6. Skowronski, Danuta M., et al. "Low 2012–13 influenza vaccine effectiveness associated with mutation in the egg-adapted H3N2 vaccine strain not antigenic drift in circulating viruses." PloS one 9.3 (2014): e92153.7. Effectiveness of the seasonal flu vaccine and new production methods8. Paules, Catharine I., et al. "The Pathway to a Universal Influenza Vaccine." Immunity 47.4 (2017): 599-603.9. Paules, Catharine I., et al. "Chasing Seasonal Influenza—The Need for a Universal Influenza Vaccine." New England Journal of Medicine 378.1 (2018): 7-9. http://www.nejm.org/doi/pdf/10.1056/NEJMp1714916Thanks for the R2A, John Parker.

Trump shut down international flights from China and others. For this, the democrats called him names which is their usual MO.Trump initiated Warp Speed for which the democrats called him a liar. They had expert after expert say that there was no way that the vaccine could be developed by the end of the year.Trump convinced Ford and others to make ventilators which the democrats said was unnecessary.Trump asked spirit distilleries to manufacture sanitizer.Trump expanded economic relief for for Covid victoms.Trump took decisive action to make certain that the hospitals has necessary resources.Trump accelerated construction of medical facilities to treat covid victims.Trump established a coronavirus incident management system to better share and respond to information about the virus.Trump made an offer to President Xi Jinping to send experts to China to investigate the coronavirus outbreak.Trump shipped CDC-Developed test kits for the Coronavirus to U.S. and international labs.The Trump Administration sent a letter to Congress requesting at least $2.5 billion to help combat the spread of the coronavirus.Trump asked the Food and Drug Administration (FDA) to allow certified labs to develop and begin testing coronavirus testing kits while reviewing pending applications.President Trump donated his fourth quarter salary to fight the coronavirus.Trump made nightly appearances on TV to update the public and take questions.Trump announced the purchase of approximately 500 million N95 respirators.Trump and VP Pence met with top health insurance companies and secured a commitment to waive co-pays for coronavirus testing.Trump directed the Small Business Administration to issue low-interest loans to affected small businesses and called on congress to increase this fund by $50 billion.Trump directed the Treasury Department to defer tax payments for affected individuals & businesses, & provide $200 billion in “additional liquidity.”Trump encouraged public-private partnerships to open up drive-through testing collection sites.Trump requested a pause on interest payments on federal student loans.Trump issued an order to the Department of Energy to purchase extra oil for the strategic petroleum reserve.Trump held a phone call with over two dozen grocery store executives to discuss on-going demand for food and other supplies.Trump arranged a partnership with Google to develop a website dedicated to coronavirus education, prevention, & local resources.Trump asked FEMA to coordinate federally-supported, state-led efforts to end coronavirus.Trump held tele-conferences with governors to discuss coronavirus preparedness.Trump led a in a call with G7 leaders who committed to increasing coordination in response to the coronavirus and restoring global economic confidence.Trump expand telehealth benefits for Medicare beneficiaries.Trump had the Army Corps of Engineers is on ”standby” to assist federal & state governments.Trump spoke to fast food executives from Wendy’s, McDonald’s and Burger King to discuss drive-thru services recommended by CDC,Trump asked Treasury Secretary Steve Mnuchin to meet with lawmakers to discuss stimulus measures to relieve the economic burden of coronavirus on certain industries, businesses, and American workers.Trump arranged a partnership between USDA, Baylor University, McLane Global, and Pepsi Co. to provide one million meals per weak to rural children in response to widespread school closures.Trump deferred $300 billion in tax payments for 90 days without penalty, up to $1 million for individuals & $10 million for business.Trump pushed the Families First Coronavirus Response Act, which provides free testing and paid sick leave for workers impacted by the coronavirus.Trump invoked the Defense Production Act in order to increase the number of necessary supplies needed to combat coronavirus.Trump ordered the U.S. Navy to deploy USNS Comfort and USNS Mercy hospital ships.Trump ordered all foreclosures and evictions suspended for a period of time.Trump requested HHS to temporarily suspend a regulation that prevents doctors from practicing across state lines.Trump arranged a Roundtable with 30 CEOs to discuss on-going public-private partnerships in response to the coronavirus pandemic.Trump arranged a deal with Carnival Cruise Lines to make ships available for use as hospitals in impacted areas to use for non-coronavirus patients.Trump arranged an agreement with Mexico to mutually restrict nonessential cross-border traffic.Trump held a call with over 12,000 small business owners to discuss relief efforts.Trump announced that the CDC will invoke Title 42 to provide the border patrol with tools to secure the border to prevent the spread of the virus.Trump asked the department of education to not enforce standardized testing requirements for the remainder of the school year.Trump allowed federal student loan borrowers to stop payments without penalty for 60 days.Trump asked HHS to place an order for hundreds of millions of N95 masks through FEMA.Trump asked the FDA to give emergency approval to a new coronavirus test that delivers results in hours.Trump approved major disaster declarations for Washington State, California, Texas, Florida, Illinois, Maryland, New Jersey, Missouri, Puerto Rico, Guam, Michigan, Massachusetts, Kentucky, Colorado, Connecticut, Oregon, Georgia, DC, North Carolina, Alabama, Kansas, Rhode Island, Ohio, Montana and Pennsylvania.Trump arranged with Governors to remain in command of National Guard forces and deploy if necessary with the federal govt funding 100% of operations costs.Trump directed the federal govt to provide 4 large federal medical stations with 2,000 beds for CA & 1,000 beds for NY & WA.Trump confirmed his administration was working with Peru & Honduras to return Americans stranded in both countries as a result of travel restrictions.Trump had FEMA issue guidance for tribal governments to seek federal assistance under the President’s emergency declaration.Trump signed an executive order invoking section 4512 of the Defense Production Act to prohibit the hoarding of vital medical supplies.Each of the 93 U.S. Attorney General offices was asked to designate a lead prosecutor to prevent hoarding.Trump asked the Treasury Department to work with the Federal Reserve to lend up to $300 billion to businesses and local governments.Trump had the Army Corps of Engineers & the National Guard are construct four hospitals and four medical centers in New York.Trump approved a major disaster declaration for the state of Iowa related to the coronavirus outbreak.Trump worked with the U.S. Army for three army hospitals to deploy their health care professionals to New York and Washington state, at the direction of Secretary of the Army Ryan McCarthy.Trump & Pence held conference calls with 140 non-profit organization leaders, including The Salvation Army & The Red Cross, to discuss coronavirus response efforts.Trump signed a bill reauthorizing The Older Americans Act, which supports senior citizens by providing meals, transportation, and other crucial services.Trump arranged a video conference with the leaders of the G20 to discuss the global coronavirus response & the need for countries to share information and data on the spread of the virus.Trump signed The Coronavirus Aid, Relief, and Economic Security (CARES) Act into law.Trump signed a Defense Production Act memorandum ordering General Motors (GM) "to accept, perform, and prioritize federal contractors for ventilators.Trump signed an executive order allowing the military to activate members of the Selected Reserve and Ready Reserve to active duty to assist with the Federal response to the coronavirus.Trump appointed Office of Trade and Manufacturing policy director Peter Navarro to serve as the Defense Production Act Policy Coordinator.Trump provided for 100,000 ventilators to be manufactured in the next 100 days, three times the amount typically manufactured in one year.Trump arranged with Boeing for the use of three "Dreamlifter" cargo air crafts to transport medical supplies across the country.Trump arranged FEMA, the CDC, the Coronavirus Task Force and Apple to release a coronavirus app which allows users to screen for their symptoms.Trump spoke with British Prime Minister Boris Johnson about the global coronavirus response and committed to helping provide ventilators to the U.K. where possible.Trump met with supply chain distributors including FedEx, Cardinal Health, and UPS to discuss ways to get state and local governments necessary medical supplies to combat the coronavirus.Trump congratulated the Army Corps of Engineers for having completed construction on a 2,900 bedroom temporary hospital at the Javits Center in New York.Trump worked with Cigna and Humana to wave co-pays for coronavirus treatment.Trump set up the Federal Government Database for hospitals to report the carona virus data.HHS accepted 30 million doses of Hydroxychloroquine, donated by Sandoz, and one million doses of Chloroquine, donated by Bayer Pharmaceuticals, for clinical trials and possible treatment of coronavirus patients.Trump encouraged private sector commitments to manufacture personal protective equipment by MyPillow, Honeywell, Jockey, Procter & Gamble, and United Technologies.Trump regularly spoke with the nation’s governors about their need for medical supplies.Trump spoke to Prime Minister Giuseppe Conte of Italy and pledged to send $100 million of medical supplies to aid Italy’s battle against coronavirusTrump arranged with Ford Motor Company to commit to producing 50,000 ventilators in the next 100 days.CMS announced new regulatory changes to cut red tape and give flexibility to America’s health care workers by relaxing hospital workforce regulations, expanding child care, meal, and laundry services for health care workers, expanding tele-health reimbursement, and more.Trump participated in a conference call with executives of American Network Service Providers to promote connectivity amid social distancing.Trump asked the Treasury Department and SBA to rapidly mobilize money from the CARES Act’s $349 billion paycheck protection program,Trump announced the Army Corps of Engineers & FEMA will construct 8 facilities with 50,000 bed capacity in California, A field hospital with 250 bed capacity in Michigan, 2 field hospitals in Louisiana with 500 bed capacity, and an alternative care sight in New Orleans with a 3,000 bed capacity.Trump spoke with Turkish President Recep Tayyip Erdogan and with their Majesties King Felipe VI and Queen Letizia of Spain about efforts to combat the coronavirus.The Treasury Department and IRS launched the employee retention credit, created by the CARES Act to incentivize businesses to keep their employees on payroll.Trump worked with the VA to expanded virtual services to veterans, continuing to provide care while limiting in-person interactions that could potentially harm vulnerable populations at VA facilities.And this only brings us to the end of March! Now your turn. What did Biden do?

You tell me. Have you seen the thousands of people in cities around the country disregarding CDC’s social distancing guidance by celebrating the election results en masse?Downtown D.C.New York’s Times Square.Scranton, PA, the President-elect’s childhood hometown.West Hollywood, CA.Now, to be crystal clear, I wouldn’t go so far as to claim that the election means that the virus is over. That’s a bit of a shorthand of the point that some have made accurately: their argument was that many media sources and political figures made much more out of the COVID-19 pandemic than was necessary to combat the virus’s spread. And the thoroughly muted criticisms - if they’re present at all - of all of those people violating CDC guidelines (and in some cases, local laws!) to celebrate President Trump’s electoral defeat would seem to prove that more subtle point.It’s hard to find a starker example of this type of selective pandemic worry than Vox’s Aaron Rupar, who couldn’t help criticizing Notre Dame students who rushed the field after a big victory but noted the “party time” outside the White House, the “double fisting champagne” in Philadelphia, and even pointed to Fox News’ coverage of the D.C. celebrants that noted the lack of violence!C'mon, man. pic.twitter.com/QPJMjDlAjP— Carolyn Needham (@CarolynNeedham) November 8, 2020That last caption applies to all four tweets, but notice that Mr. Rupar only criticized one of those situations!I won’t presume to speak for Trump supporters or even President Trump himself, but from a public health perspective, it’s obviously “not ideal” for any of these mass gatherings to be occurring. I wouldn’t use the words “fake news” for that, either: it’s simply media bias. And it seems inarguably true that many a media source will gladly worry less about public gatherings as long as they’re undertaken for the right political purpose.