Safety and efficacy of single-dose J&J vaccine in 19,630 participants
Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19
In an international, randomized, double-blind, placebo-controlled, phase 3 trial, we randomly assigned adult participants in a 1:1 ratio to receive a single dose of Ad26.COV2.S (5×1010 viral particles) or placebo. The per-protocol population included 19,630 SARS-CoV-2–negative participants who received Ad26.COV2.S and 19,691 who received placebo. Ad26.COV2.S protected against moderate to severe–critical Covid-19 with onset at least 14 days after administration (116 cases in the vaccine group vs. 348 in the placebo group; efficacy, 66.9%; adjusted 95% confidence interval [CI], 59.0 to 73.4). Vaccine efficacy was higher against severe–critical Covid-19 (76.7% [adjusted 95% CI, 54.6 to 89.1]. Despite 86 of 91 cases (94.5%) in South Africa with sequenced virus having the 20H/501Y.V2 variant, vaccine efficacy was 52.0% and 64.0% against moderate to severe–critical Covid-19 with onset at least 14 days. The incidence of serious adverse events was balanced between the two groups. Three deaths occurred in the vaccine group (none were Covid-19–related), and 16 in the placebo group (5 were Covid-19–related). A single dose of Ad26.COV2.S protected against symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection and was effective against severe–critical disease, including hospitalization and death. Safety appeared to be similar to that in other phase 3 trials of Covid-19 vaccines.
Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons
From December 14, 2020, to February 28, 2021, we used data from the “v-safe after vaccination health checker” surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic.
Adjuvanting a subunit COVID-19 vaccine to induce protective immunity
Here we demonstrate the capacity of a subunit vaccine, comprising the SARS-CoV-2 spike receptor binding domain displayed on a protein nanoparticle (RBD-NP), to stimulate robust and durable neutralizing antibody (nAb) responses and protection against SARS-CoV-2 in non-human primates. Live-virus nAb response was maintained up to 180 days post-vaccination with RBD/AS03, and correlated with protection. RBD-NP immunization cross-neutralized the B.1.1.7 variant efficiently but showed a reduced response against the B.1.351 variant. While RBD-NP/AS03 demonstrated a 4.5-fold reduction in neutralization of B.1.351, the RBD-NP/AS37 group showed a 16-fold reduction, suggesting differences in the breadth of the nAb response induced by these adjuvants.
SARS-CoV-2 Vaccine–Induced Immune Thrombotic Thrombocytopenia
The Journal has now highlighted three independent descriptions of 39 persons with a newly described syndrome characterized by thrombosis and thrombocytopenia that developed 5 to 24 days after initial vaccination with ChAdOx1 nCoV-19 (AstraZeneca). No thrombotic signal was detected in clinical trials leading to the approval of the ChAdOx1 nCoV-19 vaccine,9 which has now been administered to 34 million people worldwide. The incidence of VITT, as initially estimated, is perhaps 1 case per 100,000 exposures. This should be considered in the context of the incidence of cerebral venous sinus thrombosis in the general population (estimated at 0.22 to 1.57 cases per 100,000 per year). The very low prevalence of this complication of vaccination, however severe, relative to the benefits of preventing Covid-19 (a condition with 1 to 2% mortality and potential long-term sequelae) must be emphasized. As of April 9, 2021, at least five countries had instituted limitations — primarily based on age — on which patients should receive the ChAdOx1 nCoV-19 vaccine.
FBI Warns Against Fake Coronavirus Vaccination Cards
[Media report. See also Fake Covid-19 Shots.] "If you did not receive the vaccine, do not buy fake vaccine cards, do not make your own vaccine cards, and do not fill-in blank vaccination record cards with false information," the warning from the FBI said. "By misrepresenting yourself as vaccinated when entering schools, mass transit, workplaces, gyms, or places of worship, you put yourself and others around you at risk of contracting COVID-19." The FBI has also advised against posting photos of your vaccine card on social media.