The Manual is compiling some of the most significant news items regarding COVID-19 to help people stay up to date.
News items through April 2021 compiled by Fred R. Himmelstein, MD, FACEP. News items compiled after April 2021 compiled by Richard B. Lynn, MD.
November 10, 2021
BNT162b3 COVID-19 vaccine in children 5 to 11 years old
The data from the clinical study on the Pfizer-BioNTech COVID-19 vaccine (mRNA) in children 5 to 11 years of age was published in the New England Journal of Medicine on November 9, 2021. In June 2021, a total of 2,316 children 5 to 11 years of age were screened for inclusion, and 2,285 underwent randomization across 81 sites in the United States, Spain, Finland, and Poland. 1,517 children were randomly assigned to receive the Pfizer vaccine and 751 were assigned to receive placebo.
Adverse reactions were generally mild to moderate, lasting 1 to 2 days. Injection-site pain was the most common local reaction, occurring in about 74% of vaccine recipients. Fatigue and headache were the most frequently reported systemic reactions. Frequency of fatigue and headache was similar among vaccine and placebo recipients after the first dose. Fatigue and headache were more frequent among vaccine recipients than among placebo recipients after the second dose.
A significant immunological response was achieved by 99.2% of participants 1 month after the second dose (same immunological response rate as in vaccine recipients 16 to 25 years of age). There were 3 cases of COVID-19 (with onset 7 days or more after the second dose) among vaccine recipients and 16 among placebo recipients; the observed vaccine efficacy was 90.7% (95% CI, 67.7 to 98.3). No cases of severe COVID-19 or multisystem inflammatory syndrome were reported.
October 28, 2021
Myocarditis after BNT162b2 mRNA COVID-19 vaccine in Israel
The Israeli data on myocarditis after vaccination for COVID-19 was published in the New England Journal of Medicine on October 6, 2021. The study retrospectively reviewed data obtained from December 20, 2020 to May 31, 2021, regarding all cases of myocarditis reported to the Israeli Ministry of Health active surveillance system. By May 31, 2021, approximately 5.1 million Israelis (of 9.3 million Israeli residents) had received two doses of the COVID-19 BNT162b2 mRNA vaccine.
There were 283 cases of myocarditis reported. These cases included 142 among vaccinated persons within 21 days after the first dose or 30 days after the second dose, 40 among vaccinated persons not in proximity to vaccination, and 101 among unvaccinated persons. Of the 142 cases occurring after vaccination, the clinical presentation was judged to be mild in 95%; one fulminant case was fatal. Of 136 persons with definite or probable myocarditis, 19 presented after the first dose of vaccine and 117 after the second dose.
Comparison of the incidence of myocarditis between vaccinated and unvaccinated persons was 2.35 (95% CI, 1.10 to 5.02). This result was driven mainly by the findings for males in younger age groups. The rate ratio was highest in male recipients between the ages of 16 and 19 years (8.96; 95% CI, 4.50 to 17.83), with a ratio of 1 in 6637.
As compared with the expected incidence based on historical data, the standardized incidence ratio was 5.34 (95% CI, 4.48 to 6.40) and was highest after the second dose in male recipients between the ages of 16 and 19 years (13.60; 95% CI, 9.30 to 19.20).
The authors concluded that the incidence of myocarditis was low but increased particularly after the receipt of the second dose of the Pfizer vaccine among young male recipients. The clinical presentation of myocarditis after vaccination was usually mild.
October 13, 2021
Residual symptoms seven months after COVID-19 in people treated as outpatients
Symptomatic people who tested positive for COVID-19 at the Geneva University Hospitals in Switzerland from March 18 to May 15, 2020, were contacted again at 30 to 45 days and 7 to 9 months from diagnosis and asked about symptoms consistent with COVID-19. This study was published in the Annals of Internal Medicine in September 2021. The follow-up at 7 to 9 months after COVID-19 diagnosis was completed by 410 patients, of whom 39.0% reported residual symptoms. Fatigue (20.7%) was the most common symptom reported, followed by loss of taste or smell (16.8%), shortness of breath (11.7%), and headache (10.0%). The authors concluded that about a third of persons with mild to moderate, acute COVID-19 in an outpatient setting have long-term symptoms at 7 to 9 months.
September 27, 2021
The recent approval in the US of a third (booster) dose of the BNT162b2 messenger RNA vaccine (Pfizer–BioNTech) was based in part on the experience in Israel. In Israel, the administration of a third (booster) dose of the Pfizer vaccine was approved on July 30, 2021, for persons who were 60 years of age or older and who had received a second dose of vaccine at least 5 months earlier. A study published in the New England Journal of Medicine on September 15, 2021, reported on data collected from July 30 through August 31, 2021, regarding 1,137,804 Israeli residents who were 60 years of age or older and had been fully vaccinated (received two doses of the Pfizer vaccine) at least 5 months earlier. The rate of confirmed COVID-19 and the rate of severe illness were compared between those who had received a booster injection at least 12 days earlier and those who had not received a booster injection. The results showed that at least 12 days after the booster dose, the rate of confirmed infection was lower in the booster group than in the non-booster group by a factor of 11.3, and the rate of severe illness was lower by a factor of 19.5. The study concluded that the rates of confirmed COVID-19 and severe illness were substantially lower among those who received a booster (third) dose of the Pfizer vaccine.