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Health & Fit How Coronavirus Vaccine Side Effects Will Be Tracked in the U.S.

12:05  28 november  2020
12:05  28 november  2020 Source:   newsweek.com

Why it’s still unlikely we’ll have a Covid-19 vaccine before Election Day

  Why it’s still unlikely we’ll have a Covid-19 vaccine before Election Day Trump wants a vaccine before November, but his top advisors say that’s near impossible.“The week before last, the head of the Centers for Disease Control Dr. Redfield said it would be summer before the vaccine would become generally available to the public. You said that he was confused and mistaken,” Wallace said.

Some coronavirus vaccines are now in Phase 1/2 trials, for example, in which they are tested for On the business side , Moderna lost a patent dispute in July over some of their vaccine technology. President Trump touted their progress, hinting that a vaccine would be available before the election.

Results from vaccine trials are the most promising steps yet in the fight against the Covid-19 There are currently more than 210 coronavirus vaccines in development, according to the World Health Blood thinners may stop some of the potentially fatal effects of blood clots seen in Covid-19 patients

It looks increasingly likely that a COVID-19 vaccine may be approved in the coming weeks, with pharmaceutical companies Pfizer and Moderna both seeking Emergency Use Authorizations from the U.S. Food and Drug Administration (FDA).

text: This picture taken on November 23, 2020 shows a bottle reading © JOEL SAGET/AFP via Getty Images This picture taken on November 23, 2020 shows a bottle reading "Vaccine COVID-19" next to U.S. pharmaceutical company Pfizer and German biotechnology company BioNTech logos on November 23, 2020.

Even after approval—if it comes—government agencies and manufacturers will keep a close eye on the safety of these products as they are administered to the public.

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Eleven vaccines are in late-stage trials, including four in the United States. Pfizer’ s progress could bode well for To test a coronavirus vaccine , for instance, researchers compare how many people in the vaccinated They chose the one with fewer side effects to start a trial with more than 30,000

The vaccine was fast- tracked to human trials, but it will still be some time before it' s ready for public use. A healthy volunteer in Seattle is the first person in the U . S . to receive a dose of an experimental coronavirus vaccine as part of a new clinical trial, government health officials announced today

Regulators will only approve a vaccine if results from large Phase III clinical trials demonstrate that it is sufficiently safe and effective. This applies even in a public health emergency such as the COVID pandemic.

But these Phase III trials, which often involve tens of thousands of people, do not always uncover every potential side effect of a vaccine, so close scrutiny will continue.

"Once the vaccine is made available to the public, reports from health care professionals and from patients about side effects are monitored daily. Each safety or side effect report is reviewed individually as well as cumulatively with all other side effect reports, also employing advanced computer methods to identify safety signals for a product," said Dr. Craig Hartford, from the Faculty of Pharmaceutical Medicine in London.

How many coronavirus vaccine doses each US state will get to start

  How many coronavirus vaccine doses each US state will get to start The federal government is allocating COVID-19 vaccine doses to states according to their populations.Most states have announced how many doses they expect to receive in the first batch once a vaccine is approved.

Hopes are rising that an effective vaccine against Covid-19 will be available soon. There has been encouraging recent news about coronavirus vaccines , with some successful trials reported. But which vaccines are likely to be the most effective and how do they work?

Getting Vaccinated . Safety. In the United States, there is not yet an authorized or approved vaccine to prevent coronavirus disease 2019 (COVID-19). The federal government will oversee a centralized system to order, distribute, and track COVID-19 vaccines . All vaccines will be ordered through CDC.

In the United States, the Department of Health and Human Services has several ways to monitor and investigate adverse reactions to medicines.

One vaccine surveillance system, which has been jointly run by the Centers for Disease Control and Prevention and the FDA since 1990, is called the Vaccine Adverse Event Reporting System (VAERS.)

"VAERS takes reports of any adverse event a person experiences around the time of receiving a vaccine or that they think might be related to the vaccine. Anyone can report to VAERS—the vaccinated person, parents of vaccinated children, health care providers," Lisa Lee, a public health expert at Virginia Tech, told Newsweek.

The CDC has developed a second surveillance system, an app called V-SAFE. This will send a text or email at regular intervals to people who receive a COVID-19 vaccine, asking them questions about their health.

FDA advisory committee to consider second COVID-19 vaccine, this one from Moderna, during all-day meeting

  FDA advisory committee to consider second COVID-19 vaccine, this one from Moderna, during all-day meeting An FDA advisory panel is expected Thursday to recommend authorization of the COVID-19 vaccine developed by Moderna. It could be in states by Monday.This time, the committee is reviewing a vaccine made by Cambridge, Massachusetts, biotech Moderna, with similar technology and results as the one it supported last week by Pfizer and its German collaborator, BioNTech.

Are masks effective against coronavirus ? When will a coronavirus vaccine be available? Is it safe to go to the beach? The U . S . Centers for Disease Control and Prevention also suggests checking in online, rather than in person, and seeking activities that are outdoors instead of indoors when possible.

Just because states have been asked to have a vaccine distribution plan doesn't mean the public should expect to get shots this fall, doctors say.

If a person reports that they have felt sick, missed work, been unable to carry out normal activities or received medical are, a VAERS expert will contact them to learn more.

"Monitoring adverse events is critical for all drugs and vaccines. Clinical trials are very useful for assessing safety and efficacy of a vaccine, but sometimes people will report things we did not observe in a trial," Lee said.

"One reason to monitor and follow up on reports of adverse events is to see if others have also experienced them, or to rule out that they are related to the vaccine. We all have a vested interest in ensuring the safest and most effective vaccines and long-term monitoring helps us do that."

Approved vaccines can have side effects, but these are unusual, typically mild and wear off within days, according to Hartford.

"Serious side effects are rare," he said. "The benefits of the vaccine outweigh the risks and the safety of vaccines is very closely monitored and assessed."

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usr: 3
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