August 23, 2021

Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals
Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is scheduled to meet Friday to discuss further clinical recommendations regarding immunocompromised individuals. Today’s action does not apply to people who are not immunocompromised.

Governor Cuomo Announces COVID-19 Vaccination Mandate for Healthcare Workers
Governor Andrew M. Cuomo announced today that all healthcare workers in New York State, including staff at hospitals and long-term care facilities (LTCF), including nursing homes, adult care, and other congregate care settings, will be required to be vaccinated against COVID-19 by Monday, September 27. The State Department of Health will issue Section 16 Orders requiring all hospitals, LTCF, and nursing homes to develop and implement a policy mandating employee vaccinations, with limited exceptions for those with religious or medical reasons. To date, 75% of the state's ~450,000 hospital workers, 74% of its ~30,000 adult care facility workers, and 68% of its ~145,500 nursing home workers have completed their vaccine series. Lt. Governor Kathy Hochul's administration was briefed before the announcement.

Full vaccination suppresses SARS-CoV-2 delta variant mutation frequency
This study presents the first evidence that full vaccination against COVID-19 suppresses emergent mutations of SARS-CoV-2 delta variants. Tajima’s D test with a threshold value of -2.50, an evolution algorithm can provide a promising tool to forecast new COVID-19 outbreaks.  It remains unclear how human interventions (vaccinations, lockdowns, etc.) affect viral mutation or generate selection pressure of SARS-CoV-2. It has also been obscure if there are differences in various geographic populations. The vaccination coverage rate is inversely correlated to the mutation frequency of the SARS-CoV-2 delta variants in 16 countries of 20 countries studied. Authors also discovered delta variants evolved differently under the positive selection pressure in the United Kingdom and India. Full vaccination against COVID-19 is critical to suppress emergent mutations. Tajima’s D test score, with a threshold value of -2.50, can provide a promising tool to forecast new COVID-19 outbreaks.

Effectiveness of Pfizer-BioNTech and Moderna Vaccines in Preventing SARS-CoV-2 Infection Among Nursing Home Residents Before and During Widespread Circulation of the SARS-CoV-2 B.1.617.2 (Delta) Variant — National Healthcare Safety Network, March 1–August
Early observational studies among nursing home residents showed mRNA vaccines to be 53% to 92% effective against SARS-CoV-2 infection. Two doses of mRNA vaccines were 74.7% effective against infection among nursing home residents early in the vaccination program (March–May 2021). During June–July 2021, when B.1.617.2 (Delta) variant circulation predominated, effectiveness declined significantly to 53.1%. Multicomponent COVID-19 prevention strategies are critical, including vaccination of nursing home staff members, residents, and visitors. An additional dose of the COVID-19 vaccine might be considered for nursing home and long-term care facility residents to optimize a protective immune response.

New COVID-19 Cases and Hospitalizations Among Adults, by Vaccination Status — New York, May 3–July 25, 2021
In the United States, there are limited real-world studies of population-level vaccine effectiveness against laboratory-confirmed SARS-CoV-2 infection and COVID-19 hospitalizations. From May 3–July 25, 2021, the overall age-adjusted vaccine effectiveness against hospitalization in New York was relatively stable (91.9%–95.3%). The overall age-adjusted vaccine effectiveness against infection for all New York adults declined from 91.7% to 79.8%. These findings support the implementation of a multicomponent approach to controlling the pandemic, centered on vaccination, and other prevention strategies such as masking and physical distancing.

Sustained Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Associated Hospitalizations Among Adults — United States, March–July 2021
COVID-19 mRNA vaccines provide strong protection against severe COVID-19; however, the duration of protection is uncertain. Among 1,129 patients who received 2 doses of an mRNA vaccine, no decline in vaccine effectiveness against COVID-19 hospitalization was observed over 24 weeks. Vaccine effectiveness was 86% 2–12 weeks after vaccination and 84% at 13–24 weeks. Vaccine effectiveness was sustained among groups at risk for severe COVID-19. mRNA vaccine effectiveness against COVID-19–associated hospitalizations was sustained over 24 weeks; ongoing monitoring is needed as new SARS-CoV-2 variants emerge. To reduce hospitalization, all eligible persons should be offered COVID-19 vaccination.

Early Convalescent Plasma for High-Risk Outpatients with Covid-19
Early administration of convalescent plasma obtained from blood donors who have recovered from coronavirus disease 2019 (Covid-19) may prevent disease progression in acutely ill, high-risk patients with Covid-19. In this randomized, multicenter, single-blind trial, authors assigned patients who were being treated in an emergency department for Covid-19 symptoms to receive either one unit of convalescent plasma with a high titer of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or placebo. All the patients were either 50 years of age or older or had one or more risk factors for disease progression. In addition, all the patients presented to the emergency department within 7 days after symptom onset and were in stable condition for outpatient management. The primary outcome was disease progression within 15 days after randomization, which was a composite of hospital admission for any reason, seeking emergency or urgent care, or death without hospitalization. Secondary outcomes included the worst severity of illness on an 8-category ordinal scale, hospital-free days within 30 days after randomization, and death from any cause. A total of 511 patients were enrolled in the trial (257 in the convalescent-plasma group and 254 in the placebo group). The median age of the patients was 54 years; the median symptom duration was 4 days. In the donor plasma samples, the median titer of SARS-CoV-2 neutralizing antibodies was 1:641. Disease progression occurred in 77 patients (30.0%) in the convalescent-plasma group and 81 patients (31.9%) in the placebo group (risk difference, 1.9 percentage points; 95% credible interval, −6.0 to 9.8; posterior probability of superiority of convalescent plasma, 0.68). Five patients in the plasma group and 1 patient in the placebo group died. Outcomes regarding worst illness severity and hospital-free days were similar in the two groups. The administration of Covid-19 convalescent plasma to high-risk outpatients within 1 week after the onset of symptoms of Covid-19 did not prevent disease progression.