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By Tara C. Smith, Ph. D.
It’s the end of summer. COVID-19 has been with us for at least seven months in the United States and people are tired. The reopening of the school is messy, and everyone is still waiting for a vaccine, including myself, I would like nothing more than to come back to life to an appearance of normality and that my circle of family is protected from this virus without having to avoid friends and others who enjoy it, but I am also cautious although I love a vaccine tomorrow , I sense that reaching an effective vaccine takes time.
When I first wrote about the vaccine in March, the vaccine progression procedure was just beginning. Today, at the time of going to press, we are reaching two hundred vaccines somewhere in the progression process, according to the New York Times Vaccine Tracker. The vast majority of them, around 135 applicants, are in preclinical progression, meaning they are still being tested on cells or animals before human trials begin. Twenty-one are in phase 1 lately, which means they are being tested on a small number of people to review protection and determine the optimal dosage. Thirteen are in phase 2, which is testing the possible vaccine at a larger American organization to read more about protection. Phases 1 and 2 can also read about the immune reaction of those vaccinated to see if they are generating antibodies and responding in a different way as expected.
Phase 3 is therefore larger studies with tens of thousands of volunteers. It’s also about protection, however, this is literally where we start to know if the vaccine works and protects others from infection. There are 8 applicants in the component of this phase. Finally, there are two vaccines already approved for limited use: one from the Chinese company CanSino Biologics, which the Chinese army approved in June, and the other from the Gamaleya Russian Research Institute, whose Russian President Vladimir Putin said was approved in August. After negative reactions to the lack of evidence of protection and efficacy, the Russian government said the vaccine was approved with a “conditional registration certificate” based on Phase 3 trials (Putin, however, said one of his daughters had won the vaccine, according to the New York Times. )
So what does all of this mean in terms of having a safe and effective vaccine as temporarily as you can imagine on a human level?
To see what experts think about progressive vaccines lately and when we might have them, I spoke to Angela Rasmussen, Ph. D. , a virologist at Columbia University who has published studies on coronavirus; Alyson Kelvin, Ph. D. , virologist at Dalhousie University who focuses on breathing viruses; and Juliet Morrison, Ph. D. , virologist at the University of California, Riverside, who studies the interactions between the host and the virus. Here are your answers to frequently asked questions about the COVID-19 vaccine.
It is difficult to succeed in a consensus at this stage, with so many things still remarkable and Phase 3 trials have not yet been completed. Rasmussen points out that we deserve to have knowledge of one or more of these Phase 3 vaccines in late 2020 or early 2021 Kelvin says that so far six of these vaccines have benefited monetary and logistical benefits from the US government. But it’s not the first time Through Operation Warp Speed, the nickname for the government’s purpose of offering three hundred million doses of a safe and effective COVID-19 vaccine to the US public. But it’s not the first time Through January. 2021.
Several prospective COVID-19 vaccines rely on other types of generation of other antigens or portions of the SARS-CoV-2 virus that can stimulate an immune response. Some candidate vaccines use viral vectors, in which the SARS-CoV-2 genes are inserted into innocent viruses for the immune formula to recognize. This includes the AstraZeneca / University of Oxford vaccine and the Johnson & Johnson vaccine. Two other candidate vaccines (from Moderna and Pfizer) use mRNA generation, which consists of injecting the component that encodes the SARS-CoV-2 protein into the frame so that our own cells produce the foreign protein and expand a response. immune to it. Two other candidate vaccines from Noravax and Sanofi-GSK use SARS-CoV-2 proteins.
Theoretically, mixing other types of vaccine applicants and brands will make it more likely that at least one of them will pass a phase 3 trial. Even the ones that would possibly look smart in phase 2 are not necessarily guaranteed phase tests. 3 successful.
One of the reasons some vaccines might fail in Phase 3 is that this level of verification examines a larger and more varied population than in Phase 2. All the scientists I interviewed discussed this concern: effects in the laboratory or in a laboratory setting. small clinical trials are simply not the same as in larger and physically powerful control populations.
This is just a forward-looking impediment to a COVID-19 vaccine. Kelvin notes that the SARS-CoV-2 vaccine will face a similar challenge to our annual influenza vaccine: offering protection against upper respiratory tract infections and decreasing (nose/throat and lungs) The ideal vaccine will prevent transmission by preventing viral replication in the nose and throat and will also protect against serious diseases due to viral replication in the lungs. This can be a hard-to-find combination. “a challenge with vaccines that target respiratory viruses and are given intramuscularly,” Kelvin explains.
However, Anthony Fauci, M. D. , Director of the National Institute of Allergy and Infectious Diseases, warned that even a vaccine with 50% effectiveness is one that would “feel good” in this case; We can’t let the best be the enemy of the good. After all, the flu vaccine tends to be 40-60% effective at preventing transmission each year, and is undoubtedly still an essential tool for public health. A report in PNAS (Acts of the U. S. National Academy of Sciences) found that the flu vaccine was “only” 20% effective and had received it by only 43% of the population (approximately the number of others who received it). it would still save you 21 million infections, 129,700 hospitalizations and 62,000 deaths compared to lack of vaccine. Remember: even a “less effective” vaccine can save many lives and save you many diseases.
It is also still very pending. (See a trend?) There are many ambitious estimates that, sadly, seem to be coming to fruition.
President Trump has continuously warned that a vaccine would be obtained in 2020, “perhaps long before the year is out. ” He also warned that the United States will have a COVID-19 vaccine before the upcoming elections on November 3. Health and Human Services Secretary Alex Azar is a bit more reserved, recently saying, “We will have tens of millions of benchmarks and vaccine doses through the end of this year and several hundred million doses as we move forward. towards the beginning of next year.
Even in our accelerated progression program, many public fitness experts are involved and we are over-promising how temporarily a vaccine will be available.
Kelvin says that “the October deadline to meet expectations for a COVID-19 vaccine in time for the November elections is tight. ” She notes that for most primary vaccine candidates, Phase 3 clinical trials will take place over the next one to two years. Moderna is lately recruiting 30,000 volunteers for its phase 3 trial, however that recruitment will likely last until the end of November, and the researchers will want to stay with participants for months after enrollment to see if the vaccine works and the reasons for it. significant side effects. And this is the first vaccine to achieve this milestone; others are the Moderna calendar.
“Scientists have taken up the challenge and are compressing a procedure that generally takes a decade into a much shorter period, yet even with those efforts, virologists, vaccinologists, and immunologists perceive that we want to analyze knowledge from human trials to make sure for a vaccine to be effective and safe before we can be incorporated into the general population, “says Morrison.
In a March article in the Journal of Infectious Diseases, an organization of science and ethics experts put forward a debatable proposal to push those trials forward: intentionally infect other people vaccinated with SARS-CoV-2 phase 3 to verify the vaccine’s effectiveness. more quickly. . The article’s authors say that such trials “can take months out of the approval process, making effective vaccines available more quickly,” saving lives around the world thanks to the accelerated vaccine verification process. However, they note that this type of provocative examination carries a threat of serious illness and even death for the participants.
And, for this reason, none of the virologists I spoke to favored this suggestion. Rasmussen lists many drawbacks and few benefits for this type of COVID-19 provocation trial: “Threats to participants are huge, and even mitigate threats only to fit, low-threat, and volunteer volunteers. a low dose of virus, I wouldn’t. Get data on how a vaccine would work in others at peak risk of severe COVID-19, such as the elderly or people with pre-existing physical conditions. Kelvin agrees: “Because of the unpredictability of the results of the infection, I am of the opinion that the benefits do not outweigh the threats of human defiance studies and that these trials are not moral at the moment. “
Even once we know of an effective (or effective) vaccine, its distribution will be a challenge for several reasons.
In addition to offering budget for the progression of the vaccines itself, Operation Warp Speed would seek to lower logistical barriers to vaccine distribution. OWS budget contracts for the production of vaccine handling syringes and the production of glass vials for garage and shipping. Globally, the Gates Foundation and Gavi, the Vaccine Alliance, are also applying vaccine distribution policies and logistics to identify and fill gaps in low- and middle-income countries.
By determining the type of vaccine we end up with, there may be more demanding situations to overcome. Some vaccines want to stay very, very bloodless as they pass through the entire chain of origin, for example, which will be a challenge for distribution in some places, such as rural areas, Rasmussen says.
Then there is the charge inquiry. While insurance companies are expected to cover vaccination at no charge to beneficiaries, this is not yet set in stone. In the United States, this will be approved by the Advisory Committee on Immunization Practices (ACIP). Where will adults get their vaccines is another urgent distribution issue: at their workplaces? Local clinics? And will we want a dose or two? This can only make a decision by tracking vaccinations over time.
When a vaccine is nevertheless approved and there is a distribution plan, it is not known who will be first in line to receive the doses. Kelvin notes that the World Health Organization (WHO) has established a global allocation framework for COVID -19 products, describing precedence teams and methods for determining such equipment, and in the United States, ACIP has also developed a coVID-19 vaccine prioritization plan, based on the pandemic influenza vaccine precedence plan.
The priority teams known to date come with other people at increased risk of severe COVID-19 (such as those with pre-existing situations or old age) and workers, adding healthcare workers. These teams are very likely to have priority for immunization, followed by the general public.
However, Rasmussen notes that she is not sure that there is a transparent plan “to establish certain marginalized and disproportionately affected communities by the pandemic. ” The pandemic is already highlighting racial disparities in testing, care, and treatment, devastating black and brown communities in the United States as a result. disparities.
Once the vaccine is launched in spite of everything, the next herbal fear is: will other people get it?protection and efficacy and is backed by data, I will get the vaccine as soon as I can, just like my family. I don’t inspire other people to do something I wouldn’t do,” Rasmussen says.
Morrison urges acceptance as true with the scientists who conduct these studies every day. “Scientists are doing their homework and honestly, I haven’t had a full night’s sleep since January trying to stay sane of each and every thing,” she says. “There are also no other scientists who are committed to doing whatever they can to get us out of this situation. “
However, studies have already warned that there is a peak of hesitation about this vaccine. A recent nationally representative Gallup survey of 7632 adults warned that 35% of Americans would reject a coronavirus vaccine even if it was loose and FDA-approved. possibly come from framing the vaccine’s career. Although Dr. Fauci noted that “at this time, the FDA is not cutting corners, but is doing things much faster,” the term “distortion speed” may still give the impression that the procedure will forget protection in favor of speed. The fact that the U. S. government. make coVID-19 vaccine brand bills a subject of safe time objectives also seems to inspire protection selection.
“I’m very involved in Trump presing the FDA to factor a U. S. [emergency use authorization] for a vaccine with no evidence of effectiveness,” Rasmussen said. He points out that, at worst, the US government has not been able to do so. But it’s not the first time Posting a vaccine that it does not paint or is unsafe would be catastrophic and would lead to exposure by millions of others to an infection against which they are protected, and would undermine confidence in vaccines and fuel the feeling of vaccines, which is already a fairly significant challenge for public fitness as it is.
As we all look forward to a safe and effective vaccine, we will have to continue to protect ourselves and our communities. Wash your hands regularly and use hand sanitizer if you don’t have access to soap and water. Continue social distancing as long as you can imagine (and take care of your sanity while doing it) – minimize your trips outside your home and wear a mask when you want to pass out. Remember, just because you are attending a family circle meeting does not mean you are safe; Those kinds of gatherings are to blame for several outbreaks, so hide and stay away from anyone you don’t live with, even your circle of family members.
Finally, unfortunately, a vaccine will not be a panacea. If a vaccine is only 50% effective and only 70% of the population agrees to be vaccinated, it is unlikely that it will be superior enough to be successful at herd immunity levels. which means that the virus can continue to circulate between communities. Consistent with this and the other issues I have discussed above, Rasmussen urges other people to manage their expectations, they would possibly be difficult. “When a vaccine is approved, it will not be without delay to be had and we would not end the pandemic without delay. We will probably have several vaccines that will take time to distribute, as well as the time it will take to win hearts and minds for public health,” he says. “A vaccine will be the one at the beginning of the end, but it will be measured in months, if not in years, not in days. “
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