Saturday, December 12, 2020

FDA authorizes emergency usage for Pfizer's Vaccine

 FDA Approves Pfizer Vaccine, First Vaccine to Be Given Emergency Use  Authorization in the U.S. | Travel + Leisure

After just about 16 million cases and 298 thousand deaths, FDA announced yesterday that they will be implementing emergency usage of Pfizer's vaccine. The American government wasn't ready to embrace the vaccine previously because of the unknown side effects which now have been made apparent with the most common effect being anaphylaxis and facial muscle paralysis. But, since then, the United Kingdom has made a deal with Pfizer for millions of doses which would put Britain in the driver's lane over the U.S in terms of priority distribution. Many nations in the world are fighting for Pfizer's cure so that prompted the U.S to excuse their worries and maintain peak vaccination supply.

Although the U.S has dealt its way into 100 million doses of the vaccine, the first batch of vaccines will be delivered out to high-risk citizens such as medical care workers who have constant exposure to the virus. Residents of long-term care facilities are also prioritized because of the pattern of the elderly succumbing to the virus in higher numbers accounting for around 40% of coronavirus deaths in the U.S. In terms of the process for vaccination, one would have to be vaccinated once every two weeks for a 95% efficacy rate. 

In terms of implementation, Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, has said that the months following December all the way until estimated April will be reserved for the priority group of high exposure. After that, "I would project by the time you get to April, it will be ... 'open season,' in the sense of anyone, even the non-high priority groups could get vaccinated," Fauci said. But just because a vaccine has been deployed, doesn't mean the duty of the civilians to socially distance will be less of a burden, especially since a vaccine is deployed, we as civilians must be even more vigilant so we can expedite the date of when non-risk citizens can receive the vaccination. 

Although the vaccination seems like a godsend, the FDA trial runs concluded that less than 4.6% of the participants had severe reactions. This may seem like a low percentage, but scale that into a nation's population and the number of recipients that faced adverse reactions will seem incredibly large. 

I think the American government had every right to be cautious of the side effects especially since the FDA expedited the vaccine's trial, but that shouldn't stop them from being proactive in the procurement of the drug. This isn't like the 2002 Sars outbreak where transmission was low as a result of death rates being high; the coronavirus is an excellent medium that specializes in crowd control to infect the peak number of people. What are your thoughts on an expedited distribution of the vaccination? Would you be willing to dose yourself knowing the risks?


11 comments:

Anonymous said...

While I'm definitely glad to know that the government is taking every measure to get the COVID vaccine to the public as soon as possible, I'm definitely concerned with an expedited distribution considering how poorly our current administration handled COVID testing and restrictions. We might have a different president in office in just over a month, but until then we are under the same administration that got the U.S. stuck in an infinite loop of case spikes, and if something similar happens again, it might be too much for the Biden administration to solve in a timely manner. The high severe reaction rate is also alarming, and might turn a few people away from getting the vaccine in the first place, which is definitely dangerous for public health as well - we have enough problems with getting the public to accept vaccines without a national pandemic. That being said, I would still be willing to dose myself as it's the best way to protect myself and those around me from the virus.

Anonymous said...

Even though the US hesitated on the virus, the swift distribution that is set to occur will negate the time that the US spent dwelling on its side effects. I would personally be willing to dose myself with the vaccine even with knowing the side effects. But the other problems would be the individuals who are unwilling to take it along with the vaccines efficiency. With the increasing growth in the anti vax movement that has been seen in the recent times, its highly likely that there will be quite a few individuals who will not take the vaccine. Even though it may be a relatively small percentage, this could be a problem in future. And secondly, if the vaccine does not actually assist those with coronavirus, we will have an even greater problem as many people are somewhat depending on this vaccine so we can return to normality.

Anonymous said...

I agree with the issues Nate presented. I know that many people will be eager to take the vaccine as many others will refuse to do so. How will it be enforced? I also think that a large question will be how the US continues to track the vaccine. One thing that we have done poorly compared to other countries is contact tracing, where countries such as Spain have had seemingly flawless school re-openings with their extremely accurate system. If the US starts to provide a vaccine that has some uncommon side effects, I think they will need to roll out a better system to track side effects and efficacy to ensure that the vaccine carries out its intended purpose. As a more opinionated point of view, I think that people will ignore Fauci's remark and begin going outside more as they receive the vaccine, and I think that it will take a long time for us to reach a substantial negative trend in virus cases.

Ca$h Money said...

I think something to note is Trump’s administration threatened to fire the FDA chief if he didn’t approve the vaccine the day before it was planned to be approved. Though I don’t think this would cause anything to be overlooked, it’s a little odd and slightly suspicious given an extra day approved won’t do much (the first dose was given this morning to a nurse at a Long Island hospital). Pfizer’s vaccine did testing on people under 18 years old starting in late October, versus Moderna only starting testing on minors this past week, so I feel like Pfizer’s is a little safer for us. I work in a pharmacy, so being vaccinated is in the best interest of myself and the patients I serve, especially because people could be coming to my store to get their coronavirus vaccine. I still have concerns about long term effects, but given the state of our nation, I think they’re easily overlooked. Be cautious if you have allergies.

Anonymous said...

I definitely agree with what Kayla said. If people weren't too suspicious of the vaccine and it's reliability before, that news headline probably caused many to take a step back or re-evaluate what that means. Trump had told the FDA to either approve the vaccine by end of day or send in his resignation by then. However if they were to approve the vaccine that day or a week later, chemically and scientifically much wouldn't change about it but I think they might have lost some people's trust.

I'm curious to see the reopening of certain facilities as the vaccine is distributed. Will people wait to return to their daily routine until herd immunity is reached? Or will people feel comfortable doing so after they are vaccinated.

Overall, I think there needs to be transparency on the side effects of the vaccine and which individuals (those with allergies or pregnant) need to be cautious. Additionally, pfizer hasn't tested the vaccine on kids 16 or under so will they be last on the list? For families with younger kids, are there concerns vaccinated members serve as transmitters of the virus to them.

https://www.npr.org/sections/health-shots/2020/12/12/945288710/what-you-need-to-know-as-the-first-covid-19-vaccine-heads-your-way

Anonymous said...

I think really hope that people continue to follow social distancing and COVID-19 regulations during the vaccination months, even though I know that the number of people that follow these guidelines will decrease. Personally, I would be comfortable receiving the vaccine as I know that it's necessary to keep everyone safe. I feel like having the vaccine will be a large part of why a lot of people may be more comfortable going back to school and doing normal activities as well. Only time will tell us what the real side effects will be from this vaccine but for the most part, I feel like the risk is definitely worth taking for the advantages it can give someone.

Anonymous said...

It is definitely optimistic that the Pfizer vaccine has been approved by the FDA, however there are definitely still some valid concerns. The side effects still pose various short-term and long-term implications, and due to the newness of the virus itself, the possible long-term effects of getting infected with COVID-19 must also be considered in evaluating the efficacy and functions of the vaccine.

It is hopeful that high-risk citizens are expected to receive the vaccine as another preventative measure to ensure the health and safety of those with the greatest risk. Interesting enough, on the radio, in addition to a CNBC article, many are discussing whether or not health care workers are necessarily the obvious choice in first access to the vaccine. Medical experts are calling into question the risk of contamination within hospitals, as most hospitals have a transmission rate of zero. At this point in the pandemic, most hospitals and health care workers have been provided with the proper PPE, as some are reevaluating if more vulnerable and at risk populations, such as elderly in senior centers, or factory workers in crowded, unsanitary conditions should be prioritized over the doctors and nurses.

Dr. Ezekiel Emanuel, chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania is asking for a deeper consideration of each group set to possibly receive the first round of the vaccine, and warning against the oversimplified grouping of workers when the issue is far more complex.

"How many of you think firemen are really at high risk, or are we just lumping them in? So it seems to me we do need a serious determination of risk here if that’s our justification," Emanuel said.

It is clear as the vaccine continues to undergo more steps in the process to widespread access, that there must be more thought amongst medical experts in the distribution and limited access of the vaccine, in order to properly care for those truly at the greatest risk.

https://www.cnbc.com/2020/09/23/should-front-line-medical-workers-get-the-coronavirus-vaccine-first-not-necessarily.html

Anonymous said...

The progress in the vaccines is reassuring and having a bit more certainty as to when a vaccine will come out is nice, but with a vaccine on its way, another issue is convincing people to take said vaccine. Since the vaccine may feel a bit rushed, many people are uncertain about the side effects of this vaccine, and even care workers in nursing homes are hesitant about taking it. Even with extensive testing of the vaccine, some are still so concerned that they are planning to refuse being vaccinated, in fear that the side effects could lead nursing homes with no care takers. The article from AP News further explains that the trend of "distrust of institutions and misinformation" could be causes a lot more people to be skeptical. That being said, recent tests with 44,000 subjects reveal that the vaccine has an over 90% effectiveness, which is really good, but also means that there is a 10% chance of it failing, which is still a sizeable margin. Many of the side effects are known as well, and it seems to be safe. But regardless, people will remain skeptical of the vaccine and the next hurdle that needs to be jumped is convincing everyone to take it to keep everyone safe, especially the people who are unable to take the vaccine due to medical reasons. With a good portion of the population vaccinated, herd immunity will help slow the spread and eventually, and hopefully, stop COVID from spreading.
https://apnews.com/article/coronavirus-vaccine-nursing-homes-pfizer-8b7899de1c214989bb5fb16305b9c44e

Anonymous said...

I think it's great that we have a vaccine out since we've been in a pandemic for so long and it's definitely a little sign of hope that we need to keep pushing us forward. That being said, I would be slightly concerned with how fast the FDA approved it as well as how Trump called the day before it was approved; that all seems a little fishy to me. I think if we were given normal circumstances; in other words, we weren't in a pandemic; approving a vaccine to be administered to literally the whole world would not be a good idea, but since we are in such a huge state of emergency and every day more lives are lost, I feel like the rapidness was warranted, wanted, and extremely helpful. I am more concerned about the increasing number of people that reportedly refuse to take the vaccine. Vaccines are most helpful with herd-ammunity, especially with a vaccine that is only 95% affective. If a large majority refuse to take the vaccine, I fear that will greatly impact the vaccines success. I don't think now is a time to be selfish and I think that, unless someone has an outlying medical condition that would prevent them from taking the vaccine, everyone should have to take it.

Simone Hsu said...

I, personally, am 100% comfortable with receiving the vaccine, regardless of side effects. I understand the concerns over safety, and I believe that we have to approach those concerns from a place of empathy rather than scorn, but I do think that we need to have an aggressively pro-vaccine and pro-science stance. As we've discussed (many times!) over this semester, the United States' current media culture is extremely flawed. This is unfortunate for almost every situation, but especially so with something as important as a vaccine-- we, as a country, are grappling with massive-scale mistrust of science, and we absolutely cannot afford to. Use of both journalistic and social media fearmongering is proving incredibly detrimental to the vaccination effort because a huge portion of the population refuses to do research beyond what they see on Facebook or Twitter.

Scientifically, most people should have very little, if not nothing, to worry about. The lack of critical thinking here is, frankly, astounding. (1) The technological basis for this vaccine is not brand new, and (2) making the decision between POTENTIALLY feeling ill for a brief period post-vaccination versus continuing to suffer (physically, mentally, and economically) as an entire country should be an easy one. The American tradition of self-absorption has plagued us-- no pun intended-- throughout this entire ordeal, and it appears as though it will continue to impact us even as we are presented with a solution.

Anonymous said...

I am very much in favor of expedited distribution of the vaccine, and I would absolutely get the vaccine. First of all, the existence of side effects should not scare people as much as it does. All vaccines have a chance of causing a serious reaction, but rigorous scientific testing ensures that the probability of it happening is miniscule enough for the vaccine to be considered safe. Although anaphylaxis is a life-threatening side effect, it does not make the COVID-19 vaccine uniquely dangerous; a variety of other vaccines have been documented to have caused anaphylaxis in extremely rare cases. Additionally, I would argue that vaccination is, to some extent, a civil duty. In order to protect those who are most vulnerable, such as the elderly and immunocompromised individuals, it is crucial that enough people get vaccinated to reach herd immunity. From both a personal and a societal standpoint, the benefits of the COVID-19 vaccine far outweigh the risks.