Health Day Reporter
Monday, May 11, 2020 (HealthDay News)-Efforts to Create COVID-19 (New Coronavirus Infection) vaccine Is progressing at an unprecedented pace, and eight different candidates are currently being tested by humans around the world.
But what to have vaccine When it becomes widely available by early next year, it may be necessary to bend some rules regarding safety and testing. This is a potentially life-threatening behavior for test volunteers.
Dr. Gregory Poland, director of the Vaccine Research Group at May York Clinic in Rochester, Minnesota, said, “It is possible to get the vaccine by the fall or winter. You cannot get the vaccine by the fall or winter. Passed the safety test. Speed is a trade-off with safety. “
Government’s Leading Vaccine Expert-Dr. Anthony Fauci, Director of the US National Laboratory Allergies Infectious Diseases-Frowned in late April, proclaiming that it was “feasible” to be able to distribute millions of coronavirus vaccines by January.
Dr. David Shulkin, former Secretary of Veterans Affairs and Chief Executive Officer of Beth Israel Medical Center in New York City, said: “Traditional methods and processes for development vaccine It will take a considerable amount of time. “
However, Shulkin and other experts COVID-19 (New Coronavirus Infection) Vaccines may become available to the public sooner than the proposed 12-18 month development schedule.
Holdup is not the creation of a vaccine.World Health Organization lists 8 candidates vaccine Currently to humans Clinical trial, An additional 100 candidates have undergone preclinical evaluation in laboratories around the world.
Rather, testing each vaccine to make sure it is safe and effective is a waste of months and years, Shulkin said. HealthDay Live Stream Interview..
“Outside the United States, regulatory approvals aren’t always strict, but vaccine approvals are likely to be seen in less than the 18-month period described so far,” Shulkin said. Stated.
“Now it will be another question whether it will be safely commercialized and made available to the masses of the US population,” Shulkin continued. “But I think it’s ready for use with basic vaccine technology and healthy humans. I think this will be seen before the 18-month period.”
Poland said there are several ways the United States can speed up its own vaccine testing process, but these strategies raise important ethical issues.
Proven methods of vaccination include vaccination of people and then living their lives as usual. Research volunteers are tracked over months or years to see how many people are infected and what side effects they have.
One shortcut contains a human challenge Clinical trialIn the laboratory, people are given a laboratory vaccine and become infected with the coronavirus.
“You will start with young people,” Poland said. “You will give them an experimental vaccine. You move them to another facility, realize that we do not have a safe cure, and serious complications occur unexpectedly. Recognize and deliberately expose to the virus. But you learn very quickly, does this virus protect and cause side effects? “
On his side, Poland is not thinking COVID-19 (New Coronavirus Infection) At this time, it poses a dire threat to humans enough to justify a challenge trial.
“For example, let’s say the virus mutates and kills 30 percent instead of killing a few percent of the infected virus,” Poland assumed. “We don’t have enough antivirals to treat everyone, and we don’t have a vaccine yet. Maybe I’m taking an incompletely tested vaccine under that scenario. But do you take it under the current scenario? “
According to Poland, another way to speed up testing is to give a strong vaccine candidate an emergency use authorization.
It is currently done with antivirals Drug And virus test kit. The US Food and Drug Administration permits its use in clinical settings. Drug Also, the tests have not been fully tested and should be closely tracked to collect data on their effectiveness.
“We will give you an experimental vaccine, but you must agree to allow us to measure your temperature, draw blood and test you,” Poland. Said. “We were able to immunize many people very quickly and see what basically happened,” he added.
“I think some people are willing to make that trade-off,” Poland said. “I think there are more people who don’t want to make that trade-off.”
The problem lies in the potential for dangerous side effects such as antibody-dependent enhancement enhancement. This is a condition in which the antibodies formed in response to the vaccine actually exacerbate future infections by the virus.
“What if vaccination causes the virus to mutate and come back this fall and the vaccinated person actually gets worse?” Poland said this effect was previously with dengue and inactivated vaccines. Said it happened measles vaccine.
After testing, the remaining stagnation involves strengthening the manufacturing process so that millions of doses of vaccine are generally available-and measures have been taken to remove the obstacle.
With federal funding, companies such as Johnson & Johnson and Moderna are increasing the production of untested vaccine candidates on a so-called “risk” basis.
Dr. Walter Orenstein is Deputy Director of the Emory Vaccine Center at Emory University School of Medicine in Atlanta. He said, “We need to encourage risky development at least in some doses, so if the vaccine works, we are ready to use it immediately rather than waiting for the production period before the vaccine becomes available. It’s done. “
According to the news site, the Biomedical Advanced Research and Development Agency has invested $ 843 million to increase production of modelna vaccine candidates currently in clinical trials in humans, and will invest in Johnson & Johnson vaccines being tested in the lab. Invested $ 456 million. quartz..
Current speed, even without dangerous strategies such as challenge trials and emergency vaccine use COVID-19 (New Coronavirus Infection) As testing is ongoing, many follow-ups will be required to verify safety vaccine Eventually, it will reach the masses, Orenstein said.
“Most exams will have thousands of participants at most,” Orenstein said. “After vaccines have been used in much larger populations to look for rare adverse events, we will need a system to monitor safety.”
Follow-up will also reveal how well the protection provided by the vaccine is maintained over time, he added.
“We need to look over time to see if our immunity is weakened, and if so, if we need to give booster immunity,” Orenstein said.
“Everything needs to work to get something in January,” Orenstein concludes. “Maybe not. If you don’t have the data you need about safety and effectiveness, you need to be prepared to be longer.”
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Source: Dr. Greg Poland, MD, Director of the Vaccine Research Group at the Mayo Clinic in Rochester, Minnesota. Dr. David Shulkin, Former Secretary of Veterans Affairs, Former President and Chief Executive Officer of Beth Israel Medical Center, New York City. Walter Orenstein, MD, Deputy Director of Emory Vaccine Center, Emory University School of Medicine, Atlanta
It is possible to get the COVID-19 vaccine by the fall, but how much does it cost?
Source link It is possible to get the COVID-19 vaccine by the fall, but how much does it cost?