Tuesday, July 13, 2021

July 13: Johns Hopkins COVID 19 Report

COVID-19 Situation Report

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EPI UPDATE The WHO COVID-19 Dashboard reports 187 million cumulative cases and 4.04 million deaths worldwide as of 8:30am EDT on July 13. Global weekly incidence increased for the third consecutive week, up nearly 10% from the previous week. After 9 consecutive weeks of decline, global weekly mortality increased 3.4% compared to the previous week. The increase in weekly mortality follows 2 weeks behind the trend in weekly incidence, and while the timing is slightly earlier than the 3-4 weeks we have observed over the course of the pandemic, it is still relatively consistent with what we would expect.

Global Vaccination

The WHO reported 3.33 billion doses of SARS-CoV-2 vaccines administered globally as of July 13. The WHO reports a total of 1.28 billion individuals received at least 1 dose and 590 million are fully vaccinated. Analysis from Our World in Data shows that the global daily doses administered continues to decline rapidly from the record high of 43.1 million doses per day on June 27, now down to 29.2 million. Vaccinations are decreasing in Asia and North America, leveling off in Europe and Africa, and increasing in Oceania and South America. Our World in Data estimates that there are 1.98 billion vaccinated individuals worldwide (1+ dose; 25.4% of the global population). There are an estimated 957 million who are fully vaccinated (12.3% of the global population), although reporting is less complete than for other data.

UNITED STATES

The US CDC reported 33.7 million cumulative COVID-19 cases and 604,710 deaths. The US reported 17,753 new cases per day on July 9—a 55% increase from the low of 11,455 new cases per day on June 20—before decreasing to 15,497 on July 11. Daily mortality also “peaked” on July 9—increasing from 150 on July 6 to 167 (+11%)—before falling slightly to 156 on July 11. These fluctuations could still be a result of delayed reporting over the US Independence Day holiday weekend. Reporting should return to normal by later this week, but it could be another week before we have a clearer picture of the longer-term trends.

US Vaccination

The US has administered 335 million cumulative doses of SARS-CoV-2 vaccines, and it is administering approximately 421,000 doses per day, the lowest average since January 1. A total of 184 million individuals in the US have received at least 1 dose, equivalent to 55.5% of the entire US population. Among adults, 67.7% have received at least 1 dose as well as 9.6 million adolescents aged 12-17 years. A total of 159 million individuals are fully vaccinated, which corresponds to 48.0% of the total population. Approximately 58.9% of adults are fully vaccinated, as well as 7.4 million adolescents aged 12-17 years.

US CDC SCHOOL & CHILD CARE GUIDANCE On July 9 the US CDC released updated guidance for COVID-19 prevention in K-12 schools, prioritizing a return to in-person learning for students this fall and highlighting the importance of vaccinating as many eligible children as possible. So far, 1 in 3 adolescents ages 12 to 17 have been vaccinated, a number experts are hoping will increase over the coming months. Overall, the CDC recommends school districts tailor their recommendations to local laws and epidemiological situations, tightening or relaxing layered prevention strategies such as mask wearing and physical distancing based on local transmission rates. Some experts criticized the agency for leaving so many decisions up to local officials, saying more specific guidance would be helpful. Others, including officials with the country’s two major teachers’ unions, praised the guidance, calling it “grounded in both science and common sense.” With nearly all of the nation’s school districts set to open this fall, the CDC updated its guidance based on progress in the national vaccination campaign.

In alignment with its national recommendations for the general public, the CDC said masking could be optional for vaccinated students and school staff but unvaccinated students ages 2 and older and staff should use masks when indoors, especially when physical distancing cannot be maintained. Masks are not needed for outdoor activities such as recess or extracurricular activities, unless people are in a crowded situation, such as in the stands at a football game. The recommendation for physical distancing for students was decreased from 6 feet to 3 feet. The guidance notes that if distancing inhibits in-person learning, layering multiple other prevention strategies can be substituted. All school staff should maintain a 6-foot distance from students when possible. If the number of cases in a community begins to rise, if vaccination rates are low, or if schools cannot determine who has been vaccinated, school districts could opt for universal masking if local and state laws allow.

The CDC encouraged schools to promote vaccination among students and staff, including offering vaccinations on-site, providing sick leave for employees to get vaccinated, and excusing student absences for vaccinations. In addition, the agency said schools should support those who want to wear masks even if they are vaccinated. Schools should also consider layering other prevention strategies, including regular screening testing, improving ventilation, promoting good hand hygiene, staying home when sick, contact tracing with isolation or quarantine, and cleaning and disinfection. Cohorting, or keeping students and staff in small groups throughout the day, might be useful in some cases to limit contact, but the practice should not replace other prevention strategies nor mix vaccinated and unvaccinated individuals, the agency said. The CDC also released updated guidance for early care and education and childcare programs. With the more transmissible Delta variant now dominant in the US, it remains to be seen how local jurisdictions will enforce the CDC’s guidance in areas of low vaccination coverage, where cases and hospitalizations are already rising.

VACCINES & GUILLAIN-BARRÉ SYNDROME The US FDA announced that it is including a warning regarding the risk of Guillain-Barré syndrome (GBS), a rare but potentially serious autoimmune neurological condition, associated with the J&J-Janssen SARS-CoV-2 vaccine. To date, there have been approximately 100 preliminary reports of GBS among 12.8 million recipients of the J&J-Janssen vaccine, but additional data are required in order to establish a causal relationship. Most of the cases have been identified within 2 weeks of vaccination, and mostly among men aged 50 years and older. Regulatory officials have not identified a similar trend associated with the Pfizer-BioNTech or Moderna vaccines. However, the FDA's update comes only days after the European Medicines Agency's Pharmacovigilance Risk Assessment Committee recommended including a warning to raise awareness among healthcare professionals and people taking the AstraZeneca-Oxford vaccine of GBS cases reported following vaccination. Both the J&J-Janssen and AstraZeneca-Oxford vaccines are adenovirus vector vaccines.

While rare in terms of the frequency of cases, GBS is a known risk associated with viral infections and other vaccines. The FDA includes warnings regarding GBS risk for several common vaccines, including both the nasal mist and injection versions of the seasonal influenza vaccine and the DTaP (diphtheria, tetanus, and pertussis) vaccine. Prior research has also found elevated risk of GBS following seasonal influenza infections, which is orders of magnitude higher than from the vaccine.

On average, approximately 3,000-6,000 cases of GBS are reported annually in the US. One previous COVID-19 study involving more than 70,000 COVID-19 patients in Spain estimated the GBS risk following infection to be 0.15%, which is approximately 1,500 GBS cases per million SARS-CoV-2 infections. One previous study on GBS and seasonal influenza found the GBS risk to be approximately 1 case per million seasonal influenza vaccinations and 18 cases per million cases of seasonal influenza. Like with other adverse events identified following SARS-CoV-2 vaccination, experts emphasize that the benefits far outweigh the risks.

FULL VACCINE APPROVAL With 3 SARS-CoV-2 vaccines authorized for emergency use by the US FDA, attention is shifting toward the process for these vaccines to receive full regulatory approval. The FDA is facing pressure, including from some high-profile experts, to move quickly with the full approvals in order to encourage individuals to get vaccinated, but some experts are pushing back on the idea that the Emergency Use Authorization is discouraging Americans from getting vaccinated and that the impression that the FDA hastily issued full approval for one or more vaccines could pose the risk of harming its credibility. FDA officials have commented that the agency is moving as quickly as practicable, and the sheer volume of vaccinations administered already are providing a wealth of data for regulatory officials, which could shorten the timeline to some degree.

VACCINE DOSE STRETCHING In an effort to accelerate the pace of global immunization, scientists are exploring whether administeringa quarter of the standard dose of the Moderna SARS-CoV-2 vaccine could provide lasting immunity to more people. Similar dose-stretching strategies have been employed in the past, including with yellow fever vaccinations in Africa and South America, but no similar approach has been tried for COVID-19 despite slow vaccination rollouts in low- and middle-income countries and evolving variants of concern. To evaluate whether 2 25 microgram doses, versus the authorized 2 100 microgram doses, could elicit lasting neutralizing antibodies, researchers analyzed blood samples from 35 individuals involved in the original trial of the Moderna vaccine. In a preprint study published last week in medRxiv, the researchers report that nearly all the participants had neutralizing antibodies and various types of T cells 6 months after vaccination. The antibody and T cell levels were similar to people who had recovered from COVID-19. According to a preprint modeling study conducted by researchers from Harvard University and colleagues, vaccine dose-stretching could accelerate global vaccination efforts, helping to prevent more COVID-19 cases and related deaths than current strategies. Another trial testing lower doses of the Pfizer-BioNTech vaccine in people ages 18-55 is ongoing in Belgium.

VACCINE BOOSTER According to multiple news media reports, representatives from Pfizer met with scientists and regulatory officials from the US government this week to present information regarding the need for booster doses of its SARS-CoV-2 vaccine (developed in collaboration with BioNTech). Notably, the meeting took place privately, as opposed to other recent presentations of key vaccine safety and efficacy data that took place at public meetings of the US CDC’s Advisory Committee on Immunization Practices or the US FDA’s Vaccines and Related Biological Products Advisory Committee. Reportedly, this meeting aimed to review preliminary data and initiate discussions, as opposed to present formal arguments or make any decisions regarding the booster doses. Pfizer is expected to submit data on clinical trial participants’ immune responses following a third dose of its vaccine to the FDA in the coming weeks; however, decisions regarding guidance on booster doses likely will depend heavily on CDC data regarding breakthrough infection risk.

WHO Director-General Dr. Tedros Adhanom Ghebreyesus recently issued a statement calling for a continued focus on increasing vaccination coverage globally, rather than using much-needed doses for boosters in countries that already have high vaccination coverage. Vaccine supply has not yet met the global demand, and many countries continue to struggle to access doses for their populations. Dr. Tedros emphasized that there are divergent COVID-19 trends, with low- and middle-income countries with low coverage facing severe surges while wealthier, vaccinated countries fare better. Dr. Soumya Swaminathan, the WHO’s Chief Scientist, noted that adding a third dose of the vaccine in just 11 high- and upper-middle-income countries could require an additional 800 million doses—enough to fully vaccinate 400 million people—that are badly needed in many countries.

Despite the WHO’s call to avoid extra doses, Israel on June 12 became the first country to offer a third dose of the Pfizer-BioNTech vaccine to immunocompromised individuals. Israel Health Minister Nitzan Horowitz did not explain how the decision to offer the booster shots was reached before authorization by any major regulators, and he indicated the ministry is evaluating whether to extend the offer to the entire population.

SENEGAL VACCINE PRODUCTION On July 9, theRepublic of Senegal announced it will begin construction of a vaccine manufacturing facility at the Institut Pasteur in Dakar later this year, with support from the EU, US, and World Bank. The effort aims to produce 25 million doses of SARS-CoV-2 vaccines per month by the end of 2022, as well as manufacture vaccines for other diseases to reduce Africa's reliance on imported doses. The construction is supported by nearly €30 million (US$35 million) from Germany, France, and the EU, and the facility is expected to be finished within 18 months from the start of construction.

Africa currently relies on importation for99% of its vaccine needs. The COVID-19 pandemic has confirmed the need for local vaccine production, with less than 3% of the continent’s population vaccinated (1+ dose) and less than 1.5%fully vaccinated. During the pandemic, African countries have relied on the COVAX facility and bilateral agreements in order to obtain access to SARS-CoV-2 vaccines.COVAX anticipates delivering a total of 520 million doses of vaccine to African countries by the end of 2021 and 850 million by March 2022. That target would supply enough vaccine doses to achieve about 30% coverage in each eligible African country.

NETHERLANDS Dutch Prime Minister Mark Rutte apologized on July 12 for what he said was “poor judgment” in loosening COVID-19 restrictions, as the country’s number of new cases rose to its highest levels of the year. Despite warnings from health experts that a nearly complete reopening was premature, the Dutch government allowed bars, nightclubs, and festivals to reopen beginning on June 26 following a marked decrease in cases. Although around two-thirds of the population have at least one vaccine dose, the lifting of restrictions in combination with the circulation of the Delta variant clearly had a rapid impact on virus transmission, as the 7-day average of COVID-19 cases increased by 572% this week compared with last week. Cases are surging particularly among the young adult population, who briefly were able to take advantage of reopened nightlife. The government moved 7 regions into the highest “very serious” risk level and 10 others into the second highest “serious” risk level. Last week, almost all of the regions were within the lowest two risk levels of “vigilant” and “worrisome.” The renewed control measures went into effect on July 10 and are set to last through August 14.

AIR HANDLING A new CDC MMWR report explores safety precautions that can be taken indoors to reduce transmission of SARS-CoV-2. In particular, the combination of portable high efficiency particulate air (HEPA) cleaners with universal masking policies appears to be very effective in preventing transmission between people in close-contact indoor environments. Previous studies have shown that HEPA air cleaners, portable or built-in, can greatly reduce aerosol transmission in indoor environments. For the MMWR report, CDC researchers simulated a conference room presentation scenario by using respiratory simulators to mimic a person with COVID-19 as well as other, uninfected persons. When 2 portable HEPA air handlers were used alone, aerosol exposure was reduced by up to 65%. When masks were worn by all simulated participants without air cleaning, the aerosol exposure was reduced by 72%. However, when both air cleaning and masks were employed as mitigation measures, the aerosol exposure was reduced by up to 90%. According to the experiment, the HEPA air cleaners were most effective when placed close to the simulated infected participant. The researchers conclude that portable HEPA air cleaners and masking in combination are viable options to prevent aerosolized SARS-CoV-2 transmission, especially in environments without HVAC systems or other built-in air cleaning technology.

US IMMIGRATION DETENTION CENTERS Public health officials warn of infectious disease transmission risk at high-density facilities, andimmigration detention centers are no exception. With relatively few detainees vaccinated for SARS-CoV-2 and the total number of detainees increasing to pre-pandemic levels, US Immigration and Customs Enforcement (ICE) is reporting outbreaks and surges in new COVID-19 cases. According to a New York Times analysis of ICE data, more than 7,500 COVID-19 cases have been reported among detainees since April, accounting for more than 40% of the total reported cases in ICE facilities since the pandemic began. Experts who have visited detention centers report low adherence to public health interventions like mask wearing and physical distancing among detainees and ICE staff members. According to an ICE spokesperson, all new detainees are tested and quarantined for 14 days upon arrival. As of May, the agency’s data show only 20% of detainees received at least 1 dose of vaccine while in custody. Sharon Dolovich, a law professor and director of UCLA’sCOVID Behind Bars Data Project, said COVID-19 outbreaks would remain high among detained individuals until ICE prioritizes vaccinations. As the Delta variant takes hold in regions with low vaccination rates, public health officials warn against further outbreaks among vulnerable detainees and the potential for the development of other variants.