Pfizer-BioNTech COVID-19 Vaccine Receives Full FDA Approval

On August 23, 2021, the FDA announced that the Pfizer-BioNTech COVID-19 Vaccine was fully approved. Prior to that day, the vaccine only had Emergency Use Authorization from the FDA due to the COVID-19 pandemic. Currently, just over 173 million people in the United States are fully vaccinated, about 52.1% of the total population. For many people who were hesitant about getting the vaccine due to its Emergency Use Authorization status, this will hopefully be a turning point and they will finally get vaccinated. In addition, some vaccine mandates were held off until full approval was official. Now, with this approval, it will be easier for employers, universities, and other institutions and governmental bodies to mandate vaccines.

The vaccine is only fully approved for those ages 16 and older. Those who are 12 to 15 years of age, however, can still get the vaccine under the Emergency Use Authorization, and some experts expect full approval to extend to that age group soon. For those under the age of 12, however, there is currently not a clear timeline as to when they may be able to get a COVID-19 vaccine, as studies are still ongoing. Early data suggests that those under the age of 12 have strong immune responses and thus, may not need as large of a vaccine dose as adults. That being said, although some have suggested that Emergency Use Authorization for those under the age of 12 may come as early as mid-winter, it is still too early to tell. For many, this is difficult news, especially with the current surges in cases in children due to the Delta variant. According to the American Academy of Pediatrics (AAP), child cases of COVID-19 have surged to 180,000 from the week ending on July 22nd until just last week. If you have questions, comments, or concerns about the vaccine, please reach out to us or to your primary care provider!

More information:

Do Not Take Ivermectin to Treat or Prevent COVID-19

Poison control centers across the country have been receiving significant increases in calls from people who have taken ivermectin, a medication used for treating parasites, who are attempting to use it to prevent and treat COVID-19. The Centers for Disease Control and Prevention as well as the Federal Drug Administration are clear in saying ivermectin is not approved or recommended for use against COVID-19. Vaccination is the safest and most effective way to prevent infection and severe illness as a result of COVID-19.

Ivermectin is an anti-parasitic drug that is most commonly used in animals and livestock, however it also treats parasites in humans. For several months, conservative media hosts in the U.S. have discussed ivermectin as a potentially effective medication for COVID-19 as a result of a study that showed ivermectin killed the virus in cells growing in a lab. However, effectiveness in isolated cells does not necessarily reflect effectiveness or safety in a live human, and thus far there is no reliable evidence that ivermectin is effective in treating COVID-19. Regardless, as a result of the promotion of ivermectin by conservative media, people have been purchasing ivermectin meant for animals and taking the medication without consulting a medical professional. Inventory of ivermectin for animals is selling out in many parts of the country.

The FDA warns that animal formulations of drugs, including ivermectin, have much higher doses and more potentially toxic inactive ingredients than are safe for people. Taking ivermectin intended for animals is very dangerous. Potential side effects include nausea, vomiting, low blood pressure, and neurological side effects like seizures and changes to vision. Coma and death can also occur. The FDA also clarified that even if someone has a human prescription for ivermectin, taking it to treat COVID-19 is not approved or recommended. Human ivermectin can interact with other medications and has not been adequately tested for safety in treating COVID-19.

Despite the FDA’s warnings that ivermectin should not be used to treat COVID-19, news agencies have been reporting stories of doctors prescribing ivermectin for their patients anyway. One doctor in Arkansas is being investigated because he prescribed ivermectin thousands of times to COVID-19 patients, including incarcerated individuals, which has brought up concerns of mistreatment. 

More information:

COVID-19 Cases Continue to Rise in Michigan 

While COVID-19 cases in Michigan have not risen to the same level as states in the southern U.S., the state is not faring well. The rate of new COVID-19 cases has increased by 73% over the past week, and is more than 13 times the rate in late June. Similarly, the number of deaths due to COVID-19 has increased by 152% in the past week, and is 7 times what it was in June.

According to a report released Monday, the number of COVID-19 outbreaks in Michigan has increased by 48% in the past week.

More information:

People Ages 20-29 Account for Highest Percentage of COVID-19 Infections in Ingham County

According to data released last week, people aged 20-29 are the age group with the largest percentage of COVID-19 cases in Ingham County. 24% of cases in the last month come from that age group, followed by 17% of those aged 30-39 and 14% of those aged 40-49. 20% of cases are in people aged 19 and younger, and that rate is likely to increase as school resumes (the data are from August 22nd, before most local districts had their first day). Hospitalizations due to COVID-19 at Sparrow and McLaren are the highest they have been in nearly three months, and are still rising.

Less than 57% of Ingham County residents have been fully vaccinated.

More information:

Unvaccinated Far More Likely to Be Hospitalized Due to COVID-19, But Vaccinated People Can Still Get Sick

A new report from the CDC, based on data from over 43,000 people in Los Angeles last month, found that people who are unvaccinated are 4.9 times more likely to be infected with COVID-19 than those who are fully vaccinated, and 29.2 times more likely to be hospitalized due to COVID-19. The data are consistent with prior research: Vaccines are extremely effective at preventing severe illness from COVID-19. While people can still become infected and sick despite being vaccinated, being fully vaccinated provides a large amount of protection, making it less likely that a person will become infected, and dramatically less likely that they will experience severe symptoms. If you are medically able to get vaccinated, please do so as soon as possible!

While vaccinated people are far less likely to get sick from COVID-19, they are not totally immune and should still be taking precautions like wearing a mask and avoiding crowded places. In the last month, 23.4% of cases, 28.1% of hospitalizations, and 15.4% of COVID-19 deaths in Michigan have been people who were vaccinated. 55.6% of the population is vaccinated and it is likely that vaccinated people are taking fewer precautions than those that are unvaccinated, so the rates of infection, hospitalization, and deaths among vaccinated people are still much better than they would be if those people were unvaccinated.

More information:

COVID-19 Vaccination Made Mandatory For U.S. Military

Following the full authorization of the Pfizer vaccine earlier this week, U.S. Secretary of Defense Lloyd Austin issued a memo requiring COVID-19 vaccinations for all active-duty and reserve members of the military, including the National Guard. The memo states that "mandatory necessary to protect the Force and defend the American people." Austin went on to say that "Mandatory vaccinations are familiar to all of our Service members, and mission-critical inoculation is almost as old as the U.S. military itself." There are more than two million service members, and under 60% have received at least one dose of a COVID-19 vaccine to date. The memo did not set a timeline for vaccinations, but instead states that "The Secretaries of the Military Departments should impose ambitious timelines for implementation. Military Departments will report regularly on vaccination completion." Only the Pfizer vaccine will be required at this time.

More information:

Video Shows Louisiana Police Officer Beating Black Man, Hidden for Two Years

Earlier this week, body camera footage showing a White Louisiana State Police trooper beating a Black man, Aaron Larry Bowman, with a flashlight was obtained by the Associated Press after the State Police kept it secret for two years. The video shows Bowman being hit 18 times as he screams "I'm not resisting!," while the trooper cursed at him. The trooper later said that he hit Bowman as "pain compliance" to put him in handcuffs.

The beating resulted in a broken jaw, broken wrist, broken ribs, and a head wound that required six staples to close. State police only opened an investigation into the incident after a civil lawsuit was filed against them, 536 days after it occurred. State police released a statement that the trooper "engaged in excessive and unjustifiable actions," "intentionally mislabeled" his body cam footage, and failed to report his use of force to supervisors. The trooper resigned in March.

The incident mirrors the beating of another Black man by police in Louisiana, Ronald Greene, who died in police custody. As in Bowman's case, the video was withheld for two years until the Associated Press obtained it. 

Federal prosecutors are now investigating both incidents, and the trooper who attacked Bowman is also facing state charges.

More information:

Johnson & Johnson COVID-19 Vaccine Booster Shows Strong Immune Response

A recent report from Johnson & Johnson stated that a second dose of their COVID-19 vaccine 6 months after the first dose led to a nine-fold increase in antibodies, suggesting that a booster shot of the Johnson & Johnson vaccine would provide significant additional protection against COVID-19 infection. Currently, only one dose of the Johnson & Johnson vaccine is considered sufficient for full vaccination, unlike Pfizer and Moderna, which each require two doses. A second dose of Johnson & Johnson is therefore considered a “booster,” while that term is used for a third dose of Pfizer and Moderna. While the study is still in Phase 2 clinical trials, the data is promising and provides some positive information for the approximately 14 million people in the United States who have received the Johnson & Johnson vaccine, but are waiting to hear whether a booster shot would be needed or even an option. 

More information:

Supreme Court Denies Biden’s Appeal; “Remain in Mexico” Policy Must Be Reinstated

Earlier this week, the U.S. Supreme Court denied an attempt by the Biden administration to stay a ruling by a lower court that determined that the "Migrant Protection Protocols" (informally called "Remain in Mexico") policy put in place by former President Trump's administration must be reinstated. The policy requires asylum seekers crossing the southern border to wait in Mexico until their hearings. The result is that vulnerable people, including families and young children, must often live in potentially dangerous conditions while attempting to legally enter the U.S. for asylum.

The program was halted immediately after President Biden took office and formally ended earlier this summer, but the states of Texas and Missouri sued, arguing that the decision to end the policy was "arbitrary and capricious". The 5th Circuit Court of Appeals agreed, the Biden administration appealed, and while the appeal is pending, asked the Supreme Court to stay the decision reinstating the policy. The Supreme Court determined that the Biden administration "failed to show a likelihood of success on the claim that the memorandum rescinding the Migrant Protection Protocols was not arbitrary and capricious." Justices Breyer, Sotomayor, and Kagan disagreed. The decision does not mean that the policy must permanently remain in place, and the Biden administration's appeal is still pending.

Regardless of the ruling, migrants seeking asylum are still being denied at the border due to CDC Title 42, which is in place due to the COVID-19 pandemic. Exceptions are made for unaccompanied children, those approved on a case-by-case basis, and "programs approved by the U.S. Department of

Homeland Security (DHS) that incorporate appropriate COVID–19 mitigation protocols as recommended by CDC."

More information:

This Week's QM Round-Up Contributors (in alphabetical order):