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Politics The race to a COVID-19 vaccine requires a pledge for safety and efficacy

08:50  10 october  2020
08:50  10 october  2020 Source:   thehill.com

Children will not likely see a coronavirus vaccine until late 2021: Experts

  Children will not likely see a coronavirus vaccine until late 2021: Experts America's youngest may not be vaccinated until late next year, health experts told ABC News. © Brian Snyder/Reuters, FILE Boston Medical Center pediatrician Dr. Sara Stulac talks to the parents of two-year old Areeba Syed on the steps of their home after Areeba received a routine check-up in Boston, May 8, 2020. Despite recent evidence that children may play a larger role in the community spread of COVID-19, experts say the delay is appropriate, because a vaccine should be tested in adults first to ensure it's safe and effective before being tested in children.

COVID - 19 is a global problem. Thus vaccine nationalism is inappropriate, and America First could become America Last. Beyond the logistics of manufacturing billions of doses of a new SARS-CoV-2 vaccine , assuring efficacy and safety requires phase III clinical trials involving thousands of healthy

Safety and immune responses look good, but do these vaccines work?

A worldwide race is on to make an effective vaccine to protect against the SARS-CoV-2 virus that emerged at the end of 2019 and causes COVID-19. At present, nearly 200 different vaccines are being developed, using protocols that are well proven in previous vaccines as well as protocols that have never been successfully used in the production of a vaccine. While a vaccine is the best hope to control the COVID-19 pandemic, it is critical that safeguards not be shortchanged for speed and that the process benefits from a collaborative global effort.

Drug companies are recruiting Black Americans to participate in COVID-19 vaccine trials, trying to break down decades of mistrust

  Drug companies are recruiting Black Americans to participate in COVID-19 vaccine trials, trying to break down decades of mistrust Black Americans have been affected by the coronavirus at a disproportionate rate, but many have been wary to participate in vaccine trials. The mistrust, experts told Insider, stem from decades of medical experimentation on Black Americans. At least two pharmaceutical companies developing vaccines — Moderna and Pfizer — have been trying to recruit more Black participants in their trials. Some HBCUs, including Dillard University and Xavier University of Louisiana, have asked their own communities to consider enrollment in trials as well. Visit Business Insider's homepage for more stories.

Vaccines typically require years of research and testing before reaching the clinic, but scientists are racing to produce a safe and effective coronavirus vaccine by next year. PHASE 1 The Italian biotechnology company ReiThera has developed a Covid - 19 vaccine , called GRAd-COV2, that is

Drug makers developing Covid - 19 vaccines plan to issue a pledge not to seek government approval until the shots have proven to be safe and effective, an unusual joint move among rivals that comes as they work to address concerns over a rush to mass vaccination .

The race to a COVID-19 vaccine requires a pledge for safety and efficacy © istock The race to a COVID-19 vaccine requires a pledge for safety and efficacy

The development of a new vaccine is a painstaking process. Each vaccine target must be carefully studied for its potential for vaccine development. Once the vaccine is developed, it must pass experimental benchmarks in animals and clinical trials in healthy humans to ensure vaccine safety and efficacy; these safeguards are critical and usually take years.

But as the COVID-19 pandemic proceeds virtually unchecked in the U.S., the president has proposed "Operation Warp Speed" to develop a vaccine by the end of the year and is fixated on introducing a vaccine, proven or not, before election day.

A COVID-19 vaccine by Election Day? Here are the 3 things that would need to happen, and soon.

  A COVID-19 vaccine by Election Day? Here are the 3 things that would need to happen, and soon. Could an approved coronavirus vaccine be released before Election Day on Nov. 3? It's extremely unlikely but not impossible, experts say.President Donald Trump on Monday said, "vaccines are coming momentarily," and he has promised on multiple occasions that one will be ready before the election, now less than a month away.

Covid - 19 , with its devastating death toll, unpredictable symptoms, and many remaining unknowns, has some bioethicists questioning this conventional wisdom.They have proposed the consideration of challenge trials for Covid - 19 , although no such tests have yet been authorized.

The two-part # COVID 19 vaccine included two adenovirus vectors – recombinant human adenovirus type 26 (rAd26-S) and recombinant human Large, long-term trials including a placebo comparison and further monitoring, are needed to establish the long-term safety and effectiveness of the vaccine

The FDA, the federal agency that should safeguard us by approving only a properly tested and validated vaccine, may authorize a vaccine on only interim test data, forgoing complete safety and efficacy studies and bowing to political pressure. In response to growing concerns, the FDA has vowed to make decisions based on data.

The solace that safety and efficacy will not be shortchanged comes from pushback by pharmaceutical companies, who have issued a pledge that they will not release a vaccine for approval until it has met safety and efficacy standards. This pledge is proposed by competing pharmaceutical companies to resist pressure from the Trump administration, which has stoked public mistrust of the process and political influences on it. Three vaccines are currently in phase III trials, the final phase of testing. Despite promises by the President, these trials are unlikely to be completed by November.

Mike Pence tried to blame Kamala Harris for undermining a Covid-19 vaccine. But the public blames Trump.

  Mike Pence tried to blame Kamala Harris for undermining a Covid-19 vaccine. But the public blames Trump. Pence’s spin on a Covid-19 vaccine ignored the biggest obstacle to public trust: his boss.Moderator Susan Page asked Harris during the debate whether she would take a vaccine if one were to be approved by the Trump administration.

The world is in the midst of a COVID - 19 pandemic. As WHO and partners work together on the response -- tracking the pandemic, advising on critical interventions, distributing vital medical supplies to those in need--- they are racing to find a vaccine . Vaccines save millions of lives each year.

COVID - 19 . Will SARS-CoV-2 go the same direction as the other coronaviruses, or will it become a If, and only when, vaccine safety and efficacy is achieved in human volunteers, the logistical Manufacturing millions to billions of doses required to immunize the human population must be


Video: The Medical Center, Navicent Health researches drug to treat COVID-19 patients (WMAZ-TV Macon)

The goal of the vaccine is to establish herd immunity, where>60 percent of the population has lasting immunity, such that the number of susceptible individuals is so low and dispersed in the general population that the virus cannot maintain itself in the population.

While herd immunity can also be established naturally by letting the infection spread unfettered to about two-thirds of the population, this would result in 215.6 million people infected in the U.S. Of these, many will have long-lasting consequences of the infection and between 650,000 and 2,000,000 will die, assuming a 0.3 - 1 percent death rate. A vaccine provides a safer route to elicit long-term immunity that would last years to decades and eliminates the morbidity and mortality of natural infection.

Beyond the logistics of manufacturing billions of doses of a new SARS-CoV-2 vaccine, assuring efficacy and safety requires phase III clinical trials involving thousands of healthy volunteers in addition to the laboratory validations. A prematurely presented SARS-CoV-2 vaccine that comes with adverse effects would set back vaccine research for many years, increasing distrust and vaccine hesitancy. A vaccine should pose risk to only a tiny proportion of people, those who may react adversely due to rare genetics or physiology. In 1955 Cutter Labs in Berkley produced batches of polio vaccine that were inadequately prepared and tested, leaving live polio virus in the vaccine. The contaminated vaccine caused many children and adults to suffer from debilitating paralysis and death. Paul Offit argues in his 2005 book, The Cutter Incident: How America's First Polio Vaccine Led to the Growing Vaccine Crisis, that this incident was the beginning of vaccine hesitancy in the U.S.

171 countries are teaming up for a Covid-19 vaccine. But not the US.

  171 countries are teaming up for a Covid-19 vaccine. But not the US. Vaccine nationalism is real. But so is vaccine multilateralism.Today, there are 40 vaccine candidates for the coronavirus being studied in humans — including nine in the final phase of testing.

Safety and efficacy . After the start of the COVID - 19 pandemic Russian researchers extracted a fragment of genetic material from novel coronavirus They inserted it into a familiar adenovirus vector for delivery into a human cell creating the world’s first COVID - 19 vaccine . In order to ensure lasting

As President Trump pushes the possibility of a vaccine this year, the C.D.C. has outlined technical The C.D.C. noted in its guidance that “limited Covid - 19 vaccine doses may be available by early Democratic challenger in North Carolina’s Senate race apologizes for romantic texts to a woman who

Heavily investing in the fastest vaccine to market may not result in the most effective vaccine. Whether or not a SARS-CoV-2 vaccine can provide long-term immunity (with or without boosting) remains unclear. SARS-CoV-2 was discovered only nine months ago and time is revealing unexpected biology and pathogenesis. Quality virologic and clinical studies are the cornerstones of vaccine development, and these have only just begun.

Attaining a safe, ethically developed, and effective vaccine requires organized worldwide cooperation between nations and open collaboration of many scientists and clinicians, sharing data, repeating experiments and conducting large clinical trials. Yet the Trump administration has said that it will not enter into a global effort to develop, manufacture and equitably distribute a SARS CoV-2 vaccine.

COVID-19 is a global problem. Thus vaccine nationalism is inappropriate, and America First could become America Last. Attaining a safe and effective SARS-CoV-2 vaccine must be a victory for the entire world. As we have witnessed, viruses have no borders. As we rush toward that victory, we must work with global partners and, most importantly, take the necessary time to establish vaccine safety and efficacy.

James Alwine is a virologist and a fellow of the American Academy for Microbiology and of the American Association for the Advancement of Science. He is a professor emeritus at the University of Pennsylvania and a visiting professor at the University of Arizona. Felicia Goodrum Sterling is a virologist and a fellow of the American Academy for Microbiology. She is a professor and scientist at the University of Arizona.

Vaccine development process is safe, claims of the contrary are baseless .
Americans can have every confidence that a vaccine will receive regulatory approval only if the scientific data shows it is safe and effective. While making claims that undermine the public's confidence in an eventual vaccine candidate might make for good politics, undermining Americans' confidence may unnecessarily prolong the pandemic. If we see a successful vaccine this fall, it will be due solely to the triumph of American innovation and the private and public sectors working together in an unprecedent fashion to achieve this monumental accomplishment.Rep.

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