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EPI UPDATE The WHO COVID-19 Dashboard reports 136.3 million cases and 2.9 million deaths as of 10:15am EDT on April 13. The global weekly incidence increased for the seventh consecutive week. With 4.46 million cases, this is the fourth highest weekly total to date and the highest since the week of January 11. Global weekly mortality increased for the fourth consecutive week; the weekly total of 75,825 deaths is the highest since early February.

On April 11, India surpassed Brazil to regain the #2 position globally in terms of cumulative incidence, with 13.69 million cases. Brazil was #2, behind the US, from March 12-April 10. India remains #1 globally in terms of total daily incidence and continues to set new national records, with a 7-day average of 143,343 new cases per day. Brazil (72,030) and the US (68,960) continue to report similar daily incidence at #2 and #3, respectively. Turkey’s daily incidence (53,425; #4) is increasing as well, and if it continues on this trajectory, it could potentially approach Brazil and the US in the coming days.

Global Vaccination
The WHO reported 733.0 million vaccine doses administered globally as of April 9, including 406.7 million individuals with at least 1 dose. The dashboard does not yet include data for daily or weekly vaccinations or fully vaccinated individuals.

Our World in Data reports 805.7 million doses administered globally. The global cumulative total continues to increase at a rate of approximately 18% per week. After leveling off briefly, the daily average is once again increasing. The global daily total is now up to 17.7 million doses per day. At least 172 countries and territories* are reporting vaccination data.
*Out of 191 reporting COVID-19 incidence data.

The US CDC reported 31.0 million cumulative cases and 559,172 deaths. After leveling off briefly, potentially as a result of delayed reporting over the Easter holiday weekend, daily incidence is again increasing, up to 67,653 new cases per day, the highest average since February 19 and back above the summer 2020 peak.

US Vaccination
The US has distributed 238 million doses of SARS-CoV-2 vaccine and administered nearly 190 million doses. The US is currently administering an average of 2.9 million doses per day*, including 1.4 million people fully vaccinated.

A total of 121 million individuals have received at least 1 dose of the vaccine, equivalent to 36% of the entire US population and 47% of all adults. Of those, 74 million (22% of the total population; 29% of adults) are fully vaccinated. Among adults aged 65 years and older, 79% have received at least 1 dose, and 62% are fully vaccinated.

36 million individuals have received the Pfizer-BioNTech vaccine, 31 million have received the Moderna vaccine, and 6.8 million have received the J&J-Janssen vaccine.
*The US CDC does not provide a 7-day average for the most recent 5 days due to anticipated reporting delays for vaccine administration. This estimate is the most current value provided.

US VACCINE COVERAGE BY AGE Each state took its own approach to setting priority groups and expanding eligibility, generally starting with healthcare workers and older populations and progressively adding essential workers and people with underlying health conditions as supply increased. Because older adults were among the highest priority groups from the earliest phases of vaccination across the US, coverage among adults 65+ are inherently higher than for adults 18-64. But when we can compare the state rankings between the two age groups, we see that many states excel in coverage for one age group but not the other. For example, Texas and Indiana are ranked #11 and #15, respectively, for coverage among adults aged 65 years and older, but they are both 29 places lower for younger adults. Similarly, Delaware and Florida are closer to the median in terms of vaccination among older adults—#21 and #24, respectively—but they both rank 24 places lower for adults aged 18-64**.

Conversely, 7 states are reporting relatively higher coverage among younger adults, compared to their rank for older adults. These states tend to be concentrated a little more among the top states in terms of coverage among younger adults. In fact, New Mexico ranks #1 in terms of coverage for adults aged 18-64**, but it is only #32 for older adults. New Jersey, Hawai’i, and New York also are in the top 10 in terms of coverage among younger adults but the bottom half, or even near the bottom, for adults aged 65 years and older. New Jersey drops from #4 to #34, Hawai’i falls all the way from #6 to #47, and New York drops from #7 to #39.

Higher ranks among older adults could signal a tighter focus on older adults early in states’ vaccination efforts or a slower process to expand eligibility to younger populations, including essential workers. Higher ranks among younger adults could be an indication of more quickly including essential workers (e.g., teachers, restaurant/grocery workers, public transit workers) or younger individuals with high-risk underlying health conditions.
**Age ≥18 years but <65 years.
***For adults aged 18-64, 2 states are tied for #10.

EMERGING VARIANTS & VACCINE EFFICACY Researchers in Israel released a study (preprint) evaluating infections with B.1.1.7 and B.1.351 variants of concern (VOCs) following vaccination. The researchers implemented a case-control study involving nearly 800 patients in Israel’s largest healthcare organization. The researchers identified vaccinated individuals who subsequently tested positive for SARS-CoV-2 infection in 2 timeframes: (1) between 14 days after the first dose and 1 week after the second dose, labeled “partial [vaccine] effectiveness,” and (2) at least 1 week after the second dose, labeled as “full [vaccine] effectiveness.” Each vaccinated and infected case was matched with an infected unvaccinated control, using relevant demographic characteristics.

The researchers analyzed 247 “partial effectiveness” and 149 “full effectiveness” pairs and performed genomic sequencing to determine the infecting strain in all 792 participants. The odds of infection with the B.1.1.7 variant were significantly higher in the “partial effectiveness” vaccine group, compared to the unvaccinated control group. Additionally, the prevalence of B.1.351 infection was 8 times higher among the “full effectiveness” vaccine group, a statistically significant result. The B.1.1.7 variant is dominant in Israel, and it represents an overwhelming majority of all infections in the study—699 of 792 (88.3%). The researchers note that the increased risk of B.1.1.7 infection among partially vaccinated individuals suggests that delaying the second dose, as is the policy in some countries, could delay full protection against this VOC. Conversely, the B.1.351 variant is relatively rare in Israel, so there are less data available on these infections.

While some of the news media headlines describe the results as “alarming” or indicating that the B.1.351 variant can “evade protection” from the vaccine, the study still demonstrates robust protection under real-world conditions. Notably, there were only 11 total B.1.351 infections in the entire study—compared to 699 B.1.1.7 and 82 wild-type infections—so any single B.1.351 infection would have an outsized effect on the outcomes. Additionally, the US CDC guidance indicates that individuals can expect to develop full protection 2 weeks after the second dose, not 1 week, and the researchers note that some in the “full effectiveness” vaccine group may not have developed full protection at the time of their infection. Of the 11 B.1.351 infections, 8 were in this group, but the study does not break down the variants by the specific timing after the second dose. While the study did find some evidence of “breakthrough” (ie, infection following vaccination) for the VOCs, it was predominantly in individuals who were partially vaccinated or only recently fully vaccinated. In fact, only 76 of the 792 total participants tested positive 14 or more days after the second dose. The researchers also comment that the low prevalence of the B.1.351 variant illustrates that a combination of vaccination and COVID-19 risk mitigation measures is sufficient to contain that variant.

PFIZER-BIONTECH VACCINE EUA FOR ADOLESCENTS Pfizer and BioNTech on April 9 requested amendments to the US FDA Emergency Use Authorization (EUA) of their SARS-CoV-2 vaccine to expand its use to adolescents ages 12 to 15 years. The current EUA authorizes the vaccine’s use among people ages 16 and older. The request is based on data from a Phase 3 clinical trial among adolescents ages 12 to 15 with or without evidence of prior SARS-CoV-2 infection, which demonstrated 100% efficacy and robust antibody responses after vaccination. The trial data are not yet published, but the companies plan to submit the results for publication in a peer-reviewed journal. US CDC Director Rochelle Walensky on April 8 predicted the vaccine could be authorized for the younger age group by mid-May.

Pfizer and BioNTech also are testing their vaccine in children under age 12, with results from that Phase 1/2/3 trial expected during the second half of this year. Moderna is testing its SARS-CoV-2 vaccine among adolescents ages 12 to 17, with results from that trial expected soon, as well as among children under age 12. 

MICHIGAN Michigan remains the major COVID-19 hotspot in the US, returning to the height of its largest peak. From its most recent low on February 21, Michigan’s daily incidence has increased by a factor of 7. Michigan Governor Gretchen Whitmer has refrained from re-instituting COVID-19 risk mitigation mandates after easing many restrictions over the past several weeks and months, including increasing capacity at restaurants, resuming in-person learning, and increasing limits on indoor and outdoor gatherings. Recently, she encouraged high schools to temporarily transition to remote learning and pause athletic activities and urged diners to utilize delivery and takeout options rather than in-person dining for at least 2 weeks, but none of these measures are mandatory.

Governor Whitmer also requested that the federal government allocate additional vaccine doses to the state in response to the surge. The US government elected to continue its current allocation strategy, which is based on states’ populations to ensure equitable distribution. CDC Director Dr. Rochelle Walensky instead urged Michigan to implement COVID-19 restrictions, similar to those implemented during the summer 2020 and autumn/winter 2020 surges, to curb community transmission. Dr. Walensky noted that vaccinations will not be sufficient to make an impact on Michigan’s surge in the short term. Michigan’s current surge illustrates the ongoing COVID-19 risk, even more than a year into the US epidemic.

J&J-JANSSEN VACCINE & BLOOD CLOTTING The US CDC and FDA recommended federal and state officials temporarily pause the use of the J&J-Janssen SARS-CoV-2 vaccine while regulatory officials review data involving 6 cases of a rare and severe type of blood clot in individuals after vaccination. In a joint statement, CDC and FDA officials noted that as of April 12, 6.8 million people in the US have received the J&J-Janssen vaccine and emphasized these adverse events appear to be extremely rare. The agencies underlined they are recommending a pause in the vaccine’s use out of an abundance of caution while they evaluate the data. The CDC will convene its Advisory Committee on Immunization Practices (ACIP) on April 14 to further review the cases and discuss their potential significance.

The agencies are recommending the pause in part to alert healthcare providers to the potential for such adverse events and their unique management and treatment. The 6 cases occurred among women between the ages of 18 and 48, and the condition presented 6 to 13 days following vaccination. One woman died, and another is hospitalized in critical condition. In these cases, cerebral venous sinus thrombosis (CVST) was identified in combination with low levels of blood platelets (thrombocytopenia), according to the agencies. Typical treatment for blood clots often involves the administration of heparin (a blood thinner); however, the administration of heparin to treat CVST can be dangerous, so alternative treatments are recommended.

In a statement, J&J said it is aware of the adverse events, but no clear causal relationship to its vaccine had been established. The company emphasized it is working with regulators to investigate the cases. J&J is expected to deliver 100 million doses to the US by the end of May, and it is unclear how the pause might impact that timeline. Some experts fear the pause could set back US vaccination efforts, due to not only fewer available doses, but also the impact on public confidence in SARS-CoV-2 vaccines.

On April 9, the European Medicines Agency (EMA) announced it is investigating 4 cases of blood clotting among recently vaccinated individuals who received the J&J-Janssen vaccine in the US, in addition to expanding its probe into a possible link between blood clot events and the AstraZeneca-Oxford vaccine. On April 9, The New England Journal of Medicine published 2 studies describing 11 patients in Austria and Germany and 5 in Norway who developed rare blood clotting disorders after receiving their first dose of the AstraZeneca-Oxford vaccine. In the first study, 9 of the 11 described cases occurred among women, with patients ranging in age from 22 to 49 years, and in the second study, 4 of the 5 cases involved women, with patients ranging in age from 32 to 54 years.  

REGENERON CLINICAL TRIAL RESULTS Regeneron on April 12 released promising clinical trial results from 2 Phase 3 clinical trials of its monoclonal antibody combination treatment REGEN-COV (casirivimab with imdevimab). The first Phase 3 trial evaluated the risk of symptomatic SARS-CoV-2 infection after a single 1,200 mg subcutaneous injection of REGEN-COV. The trial enrolled 1,505 uninfected individuals at high risk of exposure (ie, household members of individuals who tested positive within the last four days) who were randomized to receive either 1 dose of REGEN-COV, administered subcutaneously, or a placebo. The risk of symptomatic infection among participants who received REGEN-COV was reduced 81% when compared to the placebo group (11 REGEN-COV recipients developed symptoms compared to 59 placebo recipients). Additionally, REGEN-COV recipients who did go on to develop symptoms experienced faster resolution of symptoms when compared with placebo recipients (average 1.2 weeks to symptom resolution for REGEN-COV recipients vs. average 3.2 weeks for placebo recipients). The antibody cocktail has also previously demonstrated in vitro ability to also prevent symptoms after exposure to COVID-19 variants of concern. Adverse events occurred in 20% of REGEN-COV recipients and 29% of placebo participants, with serious adverse events occurring in 1% of each REGEN-COV and placebo recipients. No REGEN-COV recipients were hospitalized and no deaths during the trial were attributed to REGEN-COV or COVID-19. 

Regeneron also announced the results of a Phase 3 clinical trial studying use of REGEN-COV as a treatment for recently infected asymptomatic patients. The study included 204 recently infected individuals with no SARS-CoV-2 antibodies who were randomized to receive a single 1,200 mg subcutaneous injection of REGEN-COV or placebo. The administration of REGEN-COV reduced participants’ overall risk of developing symptomatic infection by 31% compared with participants who received a placebo (29 REGEN-COV recipients developed symptoms through day 29 compared to 44 placebo recipients). Adverse events occurred in 34% of REGEN-COV recipients compared with 48% of placebo recipients. No serious adverse events or hospitalizations occurred in the REGEN-COV group, and no deaths occurred in the study. 

COVAX ROUND #3 The COVAX Facility published information on its upcoming third round of SARS-CoV-2 vaccine allocation, totaling 14.1 million doses to 47 countries from April-June 2021. The first and second rounds included 238 million doses to 142 countries. Round 2 is currently underway, and was originally scheduled to be completed by May; however, delays have shifted some deliveries past May. All of the doses to be delivered in the third round are the Pfizer-BioNTech vaccine. COVAX previously distributed a limited volume of Pfizer-BioNTech vaccine in its first allocation, but only to 18 countries that explicitly requested that version and demonstrated the ability to effectively manage the ultra-cold transportation and storage requirements. COVAX also factored in countries’ ultra-cold chain capacity in its Round 3 allocation, expanding far beyond the original 18 countries. The number of doses countries will receive in the third round range from 1,170 (Georgia) to 2.3 million (Philippines).

UK REOPENING Following a sharp rise in cases and increased incidence of the B.1.1.7 variant of concern, the UK entered a strict lockdown on January 6, 2021. As of Monday April 12, England lifted many of its lockdown restrictions and entered into their “Stage Two” restrictions. Researchers at Oxford University have stated that this lockdown, which lasted for 175 days, is among one of the longest in the world at its high stringency level. In Stage Two, shops and other businesses may open, outdoor dining may resume, and up to 6 people can meet outdoors, among other measures. Prime Minister Boris Johnson reminded the English population that many measures remain in place, including physical distancing and mask wearing, in order to prevent another surge of cases as the country reopens. The UK’s mass vaccination campaign also has enabled the country to move into the next phase of restrictions with approximately 60% of adults having received their first dose. Scotland, Wales, and Northern Ireland have slightly different schedules for reopening, with Scotland previously lifting their stay-at-home order on April 2 and Wales postponing resumption of outdoor dining until April 26. England hopes to lift all COVID-19 restrictions by mid-June in tandem with reaching its goal of vaccinating the entire adult population. 

INDIA India has recently overtaken Brazil to be the country with the second highest total number of COVID-19 cases. Although still significantly behind the US with its 31 million cases, India reported more than 13.5 million cases with a record daily high of 168,912 cases reported on April 11. Indian medical and public health professionals have pointed to complacency in risk mitigation measures, including mask wearing, physical distancing, and avoiding large gatherings, as reasons for the rise in cases. Officials are concerned the number of new cases could increase further as millions of the country’s Hindu population gather to perform religious rites in the Ganges River during the Kumbh Mela festival. As many as 5 million Hindu devotees were expected in Haridwar, in northern India, as of Monday. Although worshippers entering the region are mandated to undergo SARS-CoV-2 testing, officials warned of difficulties accommodating the size of the pilgrimage. Additionally, efforts to enforce physical distancing and masking have not been successful due to the size of the crowd and concerns for safety. With cases likely to continue surging, Indian public health authorities are redoubling efforts to increase vaccinations. Currently, about 100 million people have received their first dose, but many more will need to receive their doses in order to reach the majority of the country’s 1.36 billion population. Recently, India authorized Russia’s Sputnik V vaccine candidate for use following its review of data collected in a locally conducted Phase 3 clinical trial. India also is using the AstraZeneca-Oxford vaccine and its domestically produced Bharat Biotech vaccine.