New studies come out regularly supporting the efficacy and safety of the COVID-19 vaccines. Here’s a look as well as other COVID-19 news.
New studies come out regularly supporting the efficacy and safety of the COVID-19 vaccines. Here’s a look as well as other COVID-19 news.
Fully Vaccinated 16 Times Less Likely to Die or End up in ICU Than Immunized
A study by the Australian government found that people fully vaccinated against COVID-19 are 16 times less likely to require intensive care or die than unvaccinated people. Their research found that almost 16 out of 100,000 unvaccinated people were in an ICU or died after catching COVID-19, compared to less than one in every 100,000 who were fully vaccinated. Similar data collected in Texas found that unvaccinated people were 20 times more likely to die from COVID-19 than fully vaccinated people.
France Recommends Against Moderna COVID-19 Vaccine
France’s health authority advised against people under the age of 30 from taking the Moderna COVID-19 vaccine after a research study suggested a slightly higher risk of myocarditis and pericarditis. Both are inflammation of the heart or sac around the heart. The study was run by Epi-Phare, a consortium of health and medical agencies l’Assurance maladie (Cnam) and l’Agence du medicament (ANSM).
The research evaluated everyone between the ages of 12 and 50 who had been hospitalized between May 15 and August 31 of 2021 for myocarditis and pericarditis in France. There were 919 cases of myocarditis and 917 of pericarditis, with 60% and 36% under the age of 30, respectively. Both the Pfizer-BioNTech and Moderna mRNA vaccines appeared to increase the risk of these problems within seven days of vaccination, but the Moderna vaccine was a slightly higher risk. Their findings indicate 26.7 cases of myocarditis for every million doses of Pfizer-BioNTech vaccine and 131.6 cases for every million of the Moderna.
Pfizer Plans to Request Authorization for Vaccine Boosters for All Adults
The Pfizer-BioNTech vaccine against COVID-19 booster shot is currently authorized for certain people six months after their second dose. This includes people over 65, people with suppressed immune systems or specific health conditions, and adults whose life or work environment places them at high risk of COVID-19. The company plans to request authorization from the U.S. Food and Drug Administration (FDA) for all adults 18 and older as early as this week.
More Than 30,000 Cases of Delta-Plus Variant Identified Globally
Although not yet clear if this is of significant concern, global health authorities have identified more than 30,000 cases of a subvariant of Delta, officially known as AY.4.2 but sometimes called Delta-Plus. It has two mutations, Y145H and A222V, of the virus’s spike protein. According to the virus-reporting network GISAID, AY.4.2 now makes up 13% to 14% of new COVID-19 sequenced samples in the U.K. as of November 8. There have only been 28 cases reported in 11 states. Outbreak.Info reported 32,004 AY.4.2. cases from 37 countries.
Rochelle Walensky, M.D., director of the U.S. Centers for Disease Control and Prevention (CDC), said, “At this time, there is no evidence that the sub-lineage AY 4.2. impacts the effectiveness of our current vaccines or therapeutics, and we will continue to follow up.”
Sinovac’s COVID-19 Vaccine Safe in Pediatric and Adolescent Population
China’s Sinovac Biotech announced preliminary data on its CoronaVac COVID-19 vaccine in the pediatric and adolescent populations ranging from 3 to 17 years of age. The Phase III trial is being run in South Africa, Chile, Malaysia, and the Philippines. As of October 2021, 2,140 participants, ranging from 6 months to 17 years, have been enrolled in the study, including 684 in the safety subgroup.
In the U.S., 360,000 People Under Age 12 Have Received COVID-19 Vaccine
According to preliminary data from the CDC, more than 360,000 children under the age of 12 in the U.S. have been dosed with at least one shot of a COVID-19 vaccine. The FDA authorized the Pfizer-BioNTech vaccine 5- to 11-year age group on October 29, with a CDC recommendation following on November 2.
At this time, experts don’t think most schools will mandate vaccines for students. However, they expect that might change if the pediatric vaccine receives full regulatory approval—as opposed to emergency use authorization (EUA)—sometime next year.
Overall, according to the CDC, as of November 8, the U.S. administered 432,111,860 doses of COVID-19 vaccines, with more than 70% of adults fully vaccinated. In their data, 223,944,624 people have received at least one dose, with 194,001,108 fully vaccinated as of 6 a.m. ET on Monday, November 9. About 24.8 million have received a booster of one of the three vaccines authorized in the U.S.
Half of Rheumatology Patients Have Persistent COVID-19 Symptoms
A study from the Hospital for Special Surgery in New York City found that more than half of people with rheumatologic disease reported persistent symptoms of COVID-19 at least one month after recovering. The study involved emailed surveys to 7,505 men and women 18 years of age and older who had been treated for rheumatologic conditions at the hospital from 2018 to 2020. Of the 2,572 survey respondents, 56% who had tested positive reported symptoms lasting one month or more, including loss of taste or smell, muscle aches, and difficulty concentrating. In particular, people who smoked, took steroids, or had a chronic condition like diabetes or congestive heart failure were at high risk for long-haul symptoms.
BioNTech Updates 2021 Sales
Germany’s BioNTech, best known for its partnership with Pfizer on the COVID-19 vaccine, reported its third-quarter earnings. The estimated vaccine revenues for the year are 16 billion to 17 billion euros. Otherwise, the previous cost guidance remained the same, with R&D expenses ranging from 950 million to 1.050 billion euros, SG&A expenses from 250 million to 300 million euros, and capital expenditures of 175 million to 225 million euros.
Company Co-founder and Chief Executive Officer Ugur Sahin stated,
“We continue to work diligently to respond to global vaccine needs with a commitment to ensure equitable vaccine access. Our robust clinical and regulatory strategy has led to recent approvals that expand access to additional age groups, highlighted by the first EUA for a COVID-19 vaccine in children 5 to under 12 years of age in the United States, and authorizations for booster doses for multiple population.”
