COVID vaccine on its way

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By MIKE EDDLEMAN
Managing Editor
 As the federal government moves quickly to fast-track a pair of COVID-19 vaccines, hoping to get the first doses distributed to states by the middle of this month, many people are considering whether to get vaccinated when the time comes.
  There are those who worry about potential side effects, those who oppose vaccination in general, and those who get caught up in the mountain of misinformation health officials say is causing people to react in fear.
  “With vaccines, even if this wasn’t the COVID-19 vaccine, there is so much misinformation out there that people become very hesitant and very nervous about it,” said Dr. Caroline Hilbert with the Williamson County and Cities Health District.
  But two vaccines are expected to be approved for distribution at the end of this week, and state officials have said they may reach Texas by late next week.
 Gov. Greg Abbott announced that the Centers for Disease Control and Prevention (CDC) has made an initial allotment of over 1.4 million doses of the COVID-19 vaccines to the State of Texas. Additional allotments may be made later this month for December, and increased allotments are expected in January and through the spring.
  The two vaccines up for approval are from Pfizer and Moderna, and both require two injections weeks apart. Hilbert said everything health officials have seen to date looks promising.
  “We know about the Moderna and the Pfizer vaccines and how both of those manufacturers have filed for an emergency use authorization with the FDA (Food and Drug Administration),” she said. “The preliminary data is really looking phenomenal and is very promising. There’s just over 44,000 individuals that participated in the Pfizer trial and over 30,000 who participated in the Moderna trial, and during both those trials, through the manufacturing process, the researching process, all of the clinical trials, they found that the vaccine was both safe and effective.”
  The final hurdle this week is a meeting where the FDA will consider that emergency use authorization.
 “During that meeting, the FDA and members of its staff, and an independent board of experts, will walk through the data that hasn’t been made public and there will be time for public commentary from other experts and I imagine just members of the public as well,” Hilbert said of the process moving forward. “Then, hopefully, if the data shared then is looking as sound as the preliminary data that’s been released in the companies’ press releases, the hope is, and our anticipation is that there should be a vaccine that starts to trickle down as early as next week.”
  Concerns have been raised over how safe the vaccines will be in what many people see as a rushed development phase, but Hilbert said the process doesn’t change.
  “It’s hard with all of this information coming at us, especially with COVID, it may appear a lot of the time that responses to it have not been planned out or thought through, but when it comes to the vaccines the process for approving any vaccine – be it an emergent public health situation or normal times – these processes have been in place for decades,” Hilbert said. “While COVID itself is new, and the vaccines are new to 2020, the rigorous process they are going through have been in place and refined over decades.”
  Each phase of the clinical trials to date have been promising in terms of effectiveness and safety.
  “There are three phases of clinical trials,” she said. “The first phase you are really looking at is the vaccine safe and are there any serious side effects? They’re also starting to look (in that phase) at dosage, how much do we need to give a person to start to elicit an immune response?”
  The second phase is essentially a ramping up of trial numbers.
  “In phase two they build out the number of volunteer participants who are receiving the vaccine,” she said. “So then they start looking at now that there are more people, does it continue to be safe? Is the immune system of each person responding properly to the vaccine?”
 If the success continues, phase three means even more increase in testing and the review of the results.
“ In the case of COVID it has included tens of thousands of volunteers,” Hilbert said. “Then they present that information to the FDA.”
  Aside from minor reactions, no adverse side effects have been seen so far.
  “Not a single one had a serious adverse affect,” she said. “We do know from the preliminary data that they’re maybe some minor local reaction, like redness around the shot, there may be fever, you might have some joint pain for a day or two, but compared to what COVID does to a person, and the potential it has to do to a person, the concern with having these local reactions really is not nearly as concerning,” Hilbert said.
  Distribution plans are taking shape, but ironing out exactly who will get the first doses is still not completely settled. The directive from the FDA originally was for healthcare professionals, long-term care facility staff, EMS workers and other frontline healthcare workers to be the first group, but then the FDA added longterm care facility residents to the first group as well.
  “The vaccine is in extremely limited supply so there’s a federal group called the Advisory Committee on Immunization Practices that has been working for months to try and figure out ethically which groups do we put first in line,” Hilbert said. “At the same time there’s been an expert group here in Texas called the Texas Expert Vaccine Advisory Panel that has been trying to figure out if the guidance that comes down from the federal level is too vague, and if supply is lower than what we’re needing, how do we then even prioritize within the priority groups?”
  The State of Texas will determine distribution throughout the state according to federal guidelines.
  As more vaccine reaches the state, Hilbert said it will be important that everyone participates, otherwise the effectiveness will be compromised.
  “(If most people do not get vaccinated) You’d have same problem then that you would have with any other vaccine,” Hilbert said. “If there’s not enough vaccine coverage in a community, then anyone who is not vaccinated will still be at risk of getting the disease and the disease is still going to be able to really spread easily throughout a population. And our hospitals will continue to not get the break they need in order to provide quality care individuals need whether they be there for COVID concerns or not.”
  In addition to choosing to get vaccinated, making sure that both doses are taken will be critical.
  “Depending on the vaccine it is either three weeks later or four weeks later you have to go back, and the vaccines are not interchangeable,” Hilbert said. “There’s definitely a good amount of leg work for the facilities that are offering these vaccines and for the individuals who get it to stay on top of their care. It is important that they not just get the first shot but that they come back for the second one. We’re all working on ways to make sure individuals that receive the first shot do come back for their second shot.”
  When it comes to fear about getting the vaccine, or concern over information people may see or read regarding its safety, Hilbert said it is not unusual in relation to other vaccine concerns.
  “I don’t think the misinformation and the fear is anything new with COVID,” Hilbert said. “We’ve seen that same strong base of folks and organizations pushing out misinformation or holding on to misinformation, but COVID has really aggravated that issue and it has really grown.”
  It can be difficult to distinguish misinformation, but Hilbert said that recognizing a reaction to the information as an emotional one can be telling.
 “There’s always something new every day and every minute,” she said. “The rules applying to that misinformation are not the same rules applying to truth, so it just spreads so much easier. It preys on fear. One of the things that may be helpful for people to gut-check information as a starting point is if you feel like you’re having a very strong emotional reaction to something you’re seeing that’s a moment to stop and pause, check your sources or talk to a healthcare professional.”
  Referring to the CDC website is the best place to get the most up to date, accurate information on the COVID vaccine.
  The Williamson County Commissioners Court last week signed an agreement with Family Hospital Systems, LLC – Family Emergency Room – to provide vaccination services to first responders in Williamson County.
  “I am thankful that Family Emergency Room has once again stepped up to help meet critical needs in Williamson County as we have responded to COVID-19,” said Pct. 2 Commissioner Cynthia Long.
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