By L. Parsons Dr. Joshua LaBaer, Director of Arizona State University’s Biodesign Institute held a press conference last week concerning the COVID vaccine and the Delta variant. LaBaer began, “Our data shows that since early June, Arizona has been experiencing a surge of rapidly rising daily COVID cases. This is obviously a concern. This is impacting our hospitals at the expense of people with other illnesses.” This is a concerning trend nationwide, according to LaBaer, however, the data he shared was specific to the State of Arizona. “If you look at who is in the hospital, you can see that it is overwhelmingly people who are not vaccinated. This is clearly a pandemic of the unvaccinated.” The Delta variant, he explained, “Is driving this, largely, but we do know that the vaccines are effective against the variants of SARS-COVID II. We have learned about the Delta variant recently and one of the most notable features of it is the speed at which this variant increases the number of viruses within the person that it infects and the speed with which that person becomes ill. This particular variant is not good at evading the immune system. It responds to the vaccine, it’s just that it gets in the system so quickly that the body doesn’t have a chance to respond quickly, so the immune system is overwhelmed before the body has a chance to respond.” There are breakthrough cases, as LaBaer explained, due to the overwhelming transmissibility of the Delta variant. However, “What vaccines do is alert the body and prepare it for the potential infection by the virus. While the resistance may fade over time, after receiving the vaccine, people that become infected will respond to the virus. It just may take a few days. That is why they by and large do not end up in the hospital or become severely ill. The body’s memory system, if you will, kicks in and starts making plenty of antibodies that will prevent severe infection. “This virus is primarily spread through saliva droplets when we are speaking. We are surrounded by approximately two to three thousand droplets, a cloud, each time we speak. Therefore, people in our vicinity are going to inhale those droplets.” Recently, more data has been released on vaccine efficacy and safety. In fact, the Federal Food and Drug Administration has given the Pfizer vaccine a full approval for use in individuals over the age of 16. LaBaer emphasized that no sacrifices were made in the analysis of safety and efficacy of this vaccine. “Typically, the first phases of approval are about safety, looking at what side effects could happen and determining what ideal dosing is. Then there is the comparing of the vaccine to a placebo. Normally, we would do those phases one after the other.” He explained that in the case of these vaccines, to expedite the analysis, the safety phases were done in conjunction with the dosage regimens. “Having said that, we have to remember that on the planet, we have given 4.7 billion doses of vaccine and we have watched the outcomes of those doses more carefully than any other drug on the history of our planet. These are overwhelmingly safe and there is no evidence of long term effects. “If you are not vaccinated, the likelihood that you will get COVID-19 is extremely high, a disease that is more likely than any other in your life to put you in the hospital and to kill you. There have been people waiting for the formal approval before they would take the vaccine, well now is the time.” When asked if he believed the formal approval was rushed, LaBaer responded, “For a very long time now, the FDA has been convinced of the clinical benefits of the vaccine. What has taken them some time, in terms of reaching formal approval, is all the other aspects that go into FDA approval of any pharmaceutical. When they approve a drug, they are not only approving the drug and its safety, but also that the packaging is right, that the label and manufacturing are appropriate and so forth. In this case, the FDA visited all of the manufacturing sites and made sure they were all managed appropriately. Making sure all those elements are in place is what slows down the process. I think long ago, the data were very clear that the vaccine was safe and effective. So no, I do not believe this was rushed, I do believe it was expedited to help mitigate this disease.” Other questions have been asked about the safety of vaccines in compromised groups such as those who are pregnant. LaBaer said, “There has been enough research done now in vaccines versus pregnancy. We have studied many women who have received vaccine while pregnant and it is very clear that this is safe. Those women have not had any obvious untoward effects from the vaccine, no effects to the fetus and no effects to babies. The Center for Disease Control, therefore is suggesting women who are pregnant or thinking of becoming pregnant should get vaccinated. On the other side of that, pregnant women are more at risk for more severe outcomes of the COVID virus for her or her baby or both.” Another group that research has increased on is the immune compromised. LaBaer continued, “There has been approval by the FDA of a third vaccine dose in people who are immune compromised. One observation we have made is that people who have reasons to be immune compromised tend to have a slower response to the vaccine and require a third dose to really get a robust response. People who are immune compromised are people with cancer, people who are taking immune suppressing medications, people who have had organ transplants, and those with inherited or acquired immune deficiencies.” Finally, LaBaer spoke about the uptick in COVID cases in children. He said, “We are seeing a huge rise in COVID in children. In Arizona, around 25% of our cases are in children under the age of 18 and the most rapid rise is between the ages of five and 15. Some are ending up in the hospital.” He noted that the percentage of children who end up in the hospital is smaller than the amount of adults being hospitalized “but we don’t want to see any children in the hospital.” “We are seeing a rise in these cases at a rate that we have not seen since the beginning of this pandemic. We are seeing research for vaccinating younger kids, under 12 years old and I would expect that to be approved at least for emergency use by the end of the fall.” It is a continued recommendation by the Center for Disease Control as well as medical experts that anyone over the age of 12 is vaccinated against the COVID-19 virus.
