There was a lot of news and research studies today related to the COVID-19 vaccines. Here’s a look.
There was a lot of news and research studies today related to the COVID-19 vaccines. Here’s a look.
CDC Advisory Committee Endorses Pfizer-BioNTech Vaccine in Adolescents
After the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the use of the Pfizer-BioNTech COVID-19 vaccine in teens aged 12 to 15, the U.S. Centers for Disease Control and Prevention (CDC) vaccine advisory committee weighed in. The adcom voted 14-0 with one recusal in favor of the usage, which the agency then adopted. There are approximately 17 million teens in this age group in the U.S. that are now eligible for the vaccine.
President Biden described the decision “as one more giant step in our fight against the pandemic. The bottom line is this: A vaccine for kids between the ages of 12 and 15 … [is] safe, effective, easy, fast and free. So my hope is that parents will take advantage of the vaccine and get their kids vaccinated.”
Deaths from COVID-19 in this age group are still uncommon. Although between Jan. 1 and April 30, 2021, there were 127 adolescent COVID-19 deaths, which would have made its way into the top 10 causes of deaths among children in 2019.
Kathy Poehling, a pediatrics professor at Wake Forest University and a member of the CDC advisory panel, said, “Older children can have severe disease from … infection. Many parents and adolescents want to be protected by being vaccinated. And I’m so glad we have the vote to enable them to do that today.”
The decision was based on a trial of about 2,300 adolescents between 12 and 15 years of age, half receiving the two shots and the other half receiving placebo. There were no cases of COVID-19 in the fully vaccinated group and 16 in the placebo cohort. No details were given on the severity of the disease in those 16 patients. The group receiving the vaccine had similar side effects as adults, primarily injection site soreness and flu-like symptoms, particularly after the second dose.
CVS Health announced that it is now making appointments for the vaccine for adolescents between 12 and 15 at its more than 5,600 CVS Pharmacy locations nationally. Although walk-ins are accepted, they recommend appointments because the Pfizer-BioNTech vaccine is the only FDA-authorized COVID-19 vaccine for that age group.
More Blood Clots Linked to J&J Vaccine
The CDC reported 13 more cases of unusual blood clotting in people who received the Johnson & Johnson vaccine. There have been no additional deaths, and none of these cases were in people vaccinated after the FDA and CDC’s 11-day pause on the J&J jabs.
To date, according to the CDC, 28 people have been identified with thrombosis with thrombocytopenia syndrome (TTS) associated with the J&J vaccine. The definition is a blood clot (thrombosis) in an uncommon location such as the brain, in addition to thrombocytopenia, meaning low platelet levels.
Tom Shimabukuro, deputy director of the CDC’s Immunization Safety Office, told an agency advisory committee that though extremely rare when it was observed in so many people within two weeks of vaccination, it “suggests a plausible causal association.”
Jake Sargent, a J&J spokesman, told Bloomberg, “As additional safety information becomes available, we will continue to collaborate closely with health authorities around the world, to ensure health care professionals and individuals are fully informed, so that rare events can be identified early and treated effectively.”
Mixed & Matched Vaccines Linked to More Side Effects
One strategy considered to expand use of the COVID-19 vaccines is to allow mixing and matching, for example, for the first shot receiving the Pfizer-BioNTech vaccine and receiving the second shot AstraZeneca/Oxford vaccine. However, an early report out of the UK suggests that people who receive mixed vaccines are more likely to have mild side effects like fever, chills, fatigue, or headache. Aside from those short-lived events, there were no other safety concerns. The study was published in the Lancet.
“These are the type of reactions you do expect with vaccine,” said Matthew Snape, associate professor of pediatrics and vaccinology at the University of Oxford and chief investigator of the trial. “They are more or less the same types of reactions that you’re seeing with the standard schedules. It’s just that they’re occurring more frequently, and we’re seeing both more frequent both in mild and moderate symptoms—but they resolve quickly.”
The study included 830 volunteers 50 and older who received either two doses of the AstraZeneca/Oxford vaccine; AstraZeneca/Oxford first and Pfizer-BioNTech second; Pfizer-BioNTech first and AstraZeneca/Oxford second; or Pfizer-BioNTech as both doses. Other studies are testing mixes of vaccines by Moderna and Novavax.
Neurological Complications in Hospitalized COVID-19 Patients
According to a study published in JAMA Network Open, eight of 10 hospitalized COVID-19 patients developed neurological complications and were six times more likely than their peers to die. Half of the patients had altered brain function or structure, and about 20% were in a coma.
The research was led by University of Pittsburgh researchers for the Global Consortium Study of Neurologic Dysfunction in COVID-19. It involved 3,744 hospitalized adult COVID-19 patients at 28 sites in 13 countries from March to October 2020.
Of the 82% who reported neurologic symptoms, 37% were headaches, 26% said the loss of taste or smell, and 49% had acute encephalopathy. As mentioned, 17% were in a coma, and 6% had strokes. The rate of acute encephalopathy increased with age, at about 33% in people younger than 40 to 74% in patients older than 80.
Delaying 2nd Vaccine Dose Could Decrease Death
A predictive model suggests that giving the first dose of a COVID-19 but delaying the second dose in people under the age of 65 would result in fewer people dying of the disease. The caveat is that certain conditions would have to be met.
This strategy was used in the UK, expanding the gap between doses to 12 weeks from the recommended three to four, although Pfizer reported there was no clinical evidence to support that decision.
The UK wanted to get as many people as possible vaccinated with at least partial efficacy because of limits on available vaccines. Data from the UK showed protection against death of approximately 80% from a single dose, with a 70% drop in infections.
The newest U.S. study, published in the BMJ British journal, leveraged a simulation model based on a “real-world” sample of 100,000 U.S. adults. It tested various scenarios.
“The results suggest that under specific conditions a decrease in cumulative mortality, infections, and hospital admissions can be achieved when the second vaccine dose is delayed,” wrote the researchers, led by Thomas C. Kinglsey of the Mayo Clinic.
The specific conditions include a vaccine with a one-dose efficacy of at least 80% and daily immunization rates of 0.1% to 0.3% of a given population. The models suggested that the strategy could prevent 26 to 47 deaths per 100,000 people if those conditions were met.
