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In today's COVID-19 briefing, we erroneously stated that the authors of this comment were working for Merck and Pfizer. This is incorrect. The authors are researchers at the Johns Hopkins International Vaccine Access Center. We apologize for this error and have corrected the entry below.

EPI UPDATE The WHO COVID-19 Dashboard reports 69.14 million cases and 1.58 million deaths as of 11:00am EST on December 11.

Europe’s current COVID-19 surge/wave previously reached a peak in terms of daily incidence, and it now appears that daily mortality has begun to decline as well. We expect mortality to lag behind incidence by approximately 3 weeks; the peak in Europe’s daily mortality occurred on November 28, almost exactly 3 weeks after the peak daily incidence on November 8. While a number of European countries have yet to reach the peak in daily incidence for their respective epidemics, some have and are beginning to see associated decreases in mortality as well. Among the European countries still reporting increasing trends, only Denmark is reporting a relative increase in incidence of more than 50%.

In terms of daily mortality, Finland, Norway, and San Marino are the only 3 European countries reporting increases of more than 100% over the past 2 weeks. This is a major change from 3 weeks ago, which coincided with both the peak in daily incidence and the greatest rate of increase for COVID-19 mortality across the continent. At that time, the vast majority of countries were reporting relative increases of 100% or more.

North America surpassed Europe’s previous record in terms of per capita daily incidence—and still increasing rapidly—driven largely by the US.

The US CDC reported 15.27 million total cases and 288,762 deaths. The US surpassed 15 million cases on December 8. From the first case reported in the US on January 22, it took 96 days to reach 1 million cases.

The US also reported 3,411 deaths yesterday, and the average daily mortality climbed to 2,319 deaths per day. On April 15 New York City reported more than 3,700 previously unreported probable deaths identified since the onset of its epidemic. The US COVID-19 epidemic is more deadly now than at any point to date, and it is still accelerating. At this rate, the US will reach a cumulative mortality of 300,000 deaths in the next 5 days. Additionally, the US could surpass 330,000 deaths—which corresponds to approximately 0.1% of the entire US population or 1 death for every 1,000 people—in the next 2.5 weeks. Currently, only 6 countries worldwide have surpassed that, including Andorra and San Marino, both of which are reporting fewer than 80 total deaths. The US represents one-third of all COVID-19 cases reported globally each day and more than one-fifth of global deaths.

The Johns Hopkins CSSE dashboard reported 16.67 million US cases and 292,856 deaths as of 12:30pm EST on December 11.

UK VACCINATION As the only ongoing SARS-CoV-2 vaccination operation, countries around the world look to the UK for lessons on the complex logistics, operations, and communications necessary to implement their own future mass vaccination efforts. Early in the UK’s vaccination effort, 2 healthcare workers reportedly experienced severe allergic reactions to the vaccine. Both had reportedly experienced similar allergic reactions to vaccines in the past, and they and the vaccinators were prepared to rapidly treat the condition. Both individuals are reportedly “recovering well.”

In response to these adverse events, the UK added a warning to the safety portion of its SARS-CoV-2 vaccination information website* that notes the risk of allergic reactions, although they are “very rare.” Additionally, the Chief Executive of the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), Dr. June Raine, stated that individuals with “a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer BioNTech vaccine.” Allergic reactions in response to vaccines are not unheard of, and warnings are included for practically all (if not absolutely all) pharmaceuticals that individuals with known allergies to a product or its ingredients should consult with a doctor beforehand.

*The allergy information was not present on December 7.

US VACCINATION The US Vaccine and Related Biological Products Advisory Committee (VRBPAC) met yesterday to discuss recommendations regarding the US FDA’s issuance of an Emergency Use Authorization (EUA) for the Pfizer/BioNTech SARS-CoV-2 vaccine. Following a discussion on a myriad of related issues, ranging from vaccine safety and efficacy profiles to the effect of an EUA or vaccine approval on EUAs for future SARS-CoV-2 vaccines, VRBPAC recommended that the FDA issue an EUA for the vaccine by a vote of 17-4—with one member abstaining—for use in individuals aged 16 and older. The issue of whether to include 16- and 17-year-olds in the recommendation was reportedly a major factor in the members’ voting decisions, as some members felt there were not yet enough data available on this age group. Earlier this week, the FDA published the Pfizer/BioNTech briefing document, which includes more detailed clinical trial data than was previously available publicly. In addition to the discussion directly pertaining to the vaccine, the meeting also included presentations and discussions on other key issues, including operational distribution plans and approaches to placebo-controlled trial design as vaccines become publicly available. 

With VRBPAC’s recommendation, the FDA is expected to grant an EUA for the Pfizer/BioNTech vaccine within days. Pfizer has staged approximately 6.4 million doses that are ready to depart storage facilities within 24 hours of receiving the EUA, which would cover 3.2 million people at 2 doses per person. The full initial allotment purchased by the US government reportedly totals 100 million doses, which are scheduled to be delivered by March 2021.

In other news related to the Pfizer/BioNTech vaccine, reports emerged earlier in the week that the federal government declined an offer by Pfizer for a second allotment of millions of doses of the vaccine earlier this year. The exact circumstances remain unclear. The US may now have to wait until Pfizer meets its commitments to other countries, which could delay the delivery of a second allotment of the Pfizer/BioNTech vaccine until summer 2021. In response to concerns about shortages, US President Donald Trump signed an executive order that aims to ensure that the US receives priority access over other countries for vaccines funded through Operation Warp Speed. It is unclear exactly how the executive order can or will be enforced, but some news media outlets have speculated that it could lead to adjustments in how US agencies will guide other countries in procuring vaccines covered under this order, once the US has obtained sufficient supply.

CANADA AUTHORIZES PFIZER VACCINE On December 9, Health Canada issued an interim authorization for the Pfizer/BioNTech SARS-CoV-2 vaccine. Like the the UK and the US, the interim authorization in Canada includes plans for ongoing monitoring and analysis until enough safety and efficacy data can be collected to warrant full approval. Canada has already unveiled its national vaccination plan and initial prioritization groups in anticipation of the interim authorization. Similar to the US, Canada’s national government will be responsible for distributing the vaccine to provincial and territorial governments, which will be responsible for planning and operations to administer the vaccine to their respective populations. Canada’s Stage 1 priority groups include residents and staff at long-term care facilities for older patients, adults aged 70 and older (in 5-year increments as supply increases, starting with adults aged 80 and older), healthcare workers and support personnel who have direct patient contact, and adults in “indigenous communities where infection can have disproportionate consequences.” Stage 2 will expand eligibility to other healthcare workers, residents and staff in other congregate settings (e.g., correctional facilities), and a broader set of essential workers.

ASTRAZENECA VACCINE CLINICAL TRIAL DATA Researchers from the Oxford COVID Vaccine Trial Group published interim results on the Phase 3 clinical trials for the AstraZeneca/Oxford University candidate SARS-CoV-2 vaccine. The results, published in The Lancet, include safety and efficacy data from 4 ongoing trials in Brazil, South Africa, and the UK. Overall, the study found the vaccine to exhibit 62% efficacy among participants who received 2 full doses of the vaccine, based on data collected for more than 11,000 participants. The study identified 27 COVID-19 cases among 4,440 vaccinated participants and 72 cases among 4,455 in the placebo group. The 62% efficacy* is less than what has been reported for the Pfizer and Moderna vaccines, but better than the minimum standard set by some regulatory agencies. The trials were paused after detecting 3 cases of transverse myelitis, including 2 in vaccinated participants, but further investigation did not identify a pattern of serious adverse events associated with the vaccine.

The clinical trial data article was published alongside a commentary, authored by researchers at the Johns Hopkins International Vaccine Access Center, that discusses various aspects of the vaccine trial, production, and distribution plans. The authors note that the commitments made to support vaccine availability in low-and-middle-income countries, combined with the promising efficacy data, are cause for optimism, even if further analysis is needed to better characterize the effect of dose amount.

In addition to concerns about the low-dose subgroup, some experts have highlighted issues with the demographic composition of the participant group. Notably, 82% of the participants were aged 55 years or younger, and only 5 COVID-19 cases were identified in participants over the age of 55, which limits the trial’s ability to assess efficacy in higher-risk older individuals. Additionally, 83% of participants in the interim group were White, which similarly limits the ability to assess safety and efficacy in higher-risk racial and ethnic minority populations. There were limited data on the efficacy of the vaccine against asymptomatic infection. The authors of the report acknowledged these challenges, but suggest that the vaccine could still have some impact on asymptomatic transmission. The clinical trials are ongoing, and additional research is necessary to address these issues. Additionally, more data will hopefully provide additional insight into the vaccine’s effect on asymptomatic infection as well as the role of booster timing and dosing.

J&J VACCINE TRIAL Earlier this week, Johnson & Johnson (J&J) reportedly announced that is reducing the size of its ongoing US SARS-CoV-2 vaccine clinical trial. The ongoing COVID-19 surge in the US actually benefits the trial by increasing the rate that participants are exposed and infected, meaning that the trial can meet its designated endpoint (e.g., specific number of cases) with fewer participants. In a recent press conference Dr. Moncef Slaoui, co-lead of Operation Warp Speed, emphasized that, while Pfizer and Moderna are moving closer to receiving Emergency Use Authorization, the J&J and AstraZeneca candidates are critical to the US government’s goal of vaccinating all Americans by summer 2021. J&J temporarily paused the Phase 3 clinical trials earlier this year in order to investigate an adverse event in the trial group, but it resumed the trial on October, 23.

US HOSPITALIZATIONS As we covered previously, the US Department of Health and Human Services published facility-level data on hospital bed availability earlier this week. Following the release of the new data, efforts are already ongoing to make sense of the local-level data. Notably, The New York Times published a county-level map that illustrates the availability of intensive care unit (ICU) beds across the country. The New York Times analysis found that more than one-third of the US population lives in areas with fewer than 15% of ICU beds available, representing more than 100 million people. The analysis also provides a searchable list to provide data for specific localities and lists the most severely affected “hospital service areas” and high-population areas. Efforts like this can be a valuable resource for those who want more detailed information on hospital and health system burden during the US COVID-19 epidemic.

SOUTH AFRICA South Africa has entered its “second wave” of COVID-19. Since early in the pandemic, South Africa has been the most severely affected country in Africa, and cumulatively, South Africa leads the continent in terms of total incidence, per capita incidence*, total mortality, and per capita mortality, and it accounts for more than one-third of all cases across Africa. Many other countries’ second waves far exceeded their first, but South Africa is not yet to that point. With nearly 4,600 new cases per day, South Africa’s daily incidence is only 36% of its initial peak, but it is already 3 times the daily incidence reported in early November.

*With the exception of Cabo Verde, which has fewer than 12,000 cumulative cases and a population of only 556,000, compared to South Africa’s 829,000 cases and population of 59 million.

Like many other countries, South Africa’s second wave is being driven by younger adults, including individuals aged 15-19 years, who represent the largest proportion of newly reported cases. Notably, South African Minister of Health Dr. Zwelini Mkhize issued a statement identifying several large music festivals as superspreader events. Dr. Mkhize also encouraged parents to limit the participation of children and young adults in these types of events, particularly because superspreader events inevitably spill over into the broader community, including higher-risk older adults and those with underlying health conditions. Despite the surge in incidence, the entire country remains at Alert Level 1, the least restrictive of 5 levels. On December 3, however, South Africa declared the Nelson Mandela Bay area as a COVID-19 hotspot. Nelson Mandela Bay remains at Alert Level 1, but with additional restrictions, including a 10pm curfew; limiting alcohol sales to 10am-6pm Monday through Thursday; prohibiting alcohol consumption in public spaces like beaches and parks; and restricting indoor gatherings, including religious services, to 100 people or fewer. As it looks ahead to the prospect of vaccine availability in the coming weeks and months, South Africa aims to contain COVID-19 spread without moving to more restrictive “lockdowns” like it implemented earlier this year.

MALES & DISEASE SEVERITY A meta-analysis published in Nature Communications provides evidence that male sex is a risk factor for severe COVID-19 disease and death. Researchers from the UK and South Africa collected case data from 90 COVID-19 studies implemented in 46 countries and 44 US states, covering more than 3.1 million COVID-19 cases. The analysis found little difference in the infection rates between male and female sex, but the researchers identified a statistically significant increase in both mortality and admission to intensive care/treatment units for male COVID-19 patients. The data suggest that males were 1.4 times more likely to die from COVID-19 than females and almost twice as likely to be admitted to an ICU/ITU. As the pandemic continues, it is critical to gain a clearer understanding of the myriad of risk factors, particularly for severe disease and death, and meta-analyses like this can glean important lessons from across many independent research efforts.

RACIAL & ETHNIC DISPARITIES As we have covered throughout the pandemic, racial and ethnic minorities are experiencing a disproportionate burden in terms of COVID-19 incidence and mortality, due to a range of factors, including prevalence of underlying health conditions and a variety of social and economic drivers. Two studies published late last week, one in JAMA: Network Open and the other in the US CDC’s MMWR, provide further insight into the effect of COVID-19 on racial and ethnic minority populations.

The study published in JAMA: Network Open was conducted by researchers at the New York University Grossman School of Medicine (US), and they found that Black and Hispanic patients had “higher rates of [COVID-19] hospitalization and mortality than White [patients] but lower in-hospital case-fatality rates.” The study included nearly 10,000 patients across the New York University Langone Health health system. Of these patients, nearly 50% tested positive for SARS-CoV-2, and 54% of those patients were hospitalized for COVID-19. Among the study participants, Black (aOR=1.6) and Hispanic patients (aOR=1.7) had significantly higher odds of testing positive for SARS-CoV-2 than White patients. Asian patients were significantly more likely than White patients to be hospitalized after testing positive (aOR=1.5), but there was no difference identified among Black or Hispanic patients. Among hospitalized patients, Black patients had lower odds of developing severe disease than White patients (aOR=0.7), and Hispanic and Asian patients had similar odds. Additionally, Black patients were significantly less likely to die than White patients (aHR=0.7), even after adjusting for disease severity. Hispanic and Asian patients exhibited similar risk of death as White patients. While racial and ethnic minorities, overall, experienced elevated COVID-19 burden, including death, this study found evidence that White patients may be at elevated risk of severe disease and death once hospitalized.

The study published in the MMWR was conducted by researchers in Denver, Colorado (US), who interviewed or reviewed the medical records of every laboratory-confirmed COVID-19 patient in Denver from March-October, covering 10,163 cases, 1,087 hospitalizations, and 165 deaths. The researchers note that “overall, the proportions of COVID-19 cases, hospitalizations, and deaths among Hispanic adults were approximately double the proportion of Hispanic adults in the Denver community,” illustrating the disproportionate effect of COVID-19 on this community. The researchers found that Hispanic patients were significantly younger than non-Hispanic patients and more likely to experience COVID-19 symptoms and be hospitalized. Additionally, the time to receive a laboratory test was longer among Hispanic patients. Hispanic patients were also more likely to work in an “essential industry” and more likely to report working while feeling ill. Hispanic patients reported larger household size, and they were more likely to report having household contact with a known COVID-19 case. Previous studies have identified increased prevalence of underlying health conditions among Hispanic populations, but this study highlights some of the social and economic factors that contribute to increased COVID-19 burden on racial and ethnic minorities, including their outsized role in performing essential duties in the community and increased risk of household transmission.

The Ohio State University and the University of Michigan, originally scheduled for tomorrow, December 12, has been cancelled. The announcement was made on Tuesday, following continued detection of new COVID-19 cases among Michigan players and staff. Michigan’s Athletic Director, Warde Manuel, stated that, the team had not been cleared to resume practice and that Michigan would not be able to field a team due to active COVID-19 cases and quarantine protocols for close contacts. Notably, the last time Michigan and Ohio State did not play each other was 1917, during the height of World War I and the year before the 1918 influenza pandemic.

With only 5 completed games this year, there were questions regarding whether Ohio State would be eligible to compete in the Big Ten Conference Championship, despite its undefeated record. Prior to the season, the Big Ten Conference established a rule requiring teams to complete 6 games in order to be eligible to play in the conference championship game. With 3 cancelled games, Ohio State will have only played 5 of its 8 scheduled games this season. Ohio State’s head coach, Ryan Day, called on Big Ten leadership to review the rule and evaluate whether Ohio State could be eligible to play for the conference championship. Following the decision to cancel the game against Michigan, the Big Ten Conference Administrators Council “voted...to eliminate the minimum-game requirement for participation in the 2020 Big Ten Football Championship Game,” which will allow Ohio State to play Northwestern University in the championship game scheduled for December 19.

Like many other sporting events, particularly those with international competitors, the America’s Cup (sailing) schedule and events were disrupted by COVID-19. While warm-up regattas were originally scheduled around the world throughout 2020, most were cancelled. The sailors will finally take flight next week with the World Series event and Christmas Race in Auckland, New Zealand.

With international travel restrictions still in place, New Zealand is closely monitoring arriving travelers, including those arriving by sea. Reportedly, New Zealand’s Ministry of Health will permit ships and boats to enter the country for necessary repairs; however, health and customs officials have been closely monitoring these requests, in part, due to concerns that they could be exploited by international visitors who wish to watch the Prada Challenger’s Cup and America’s cup races in person in January-March 2021. Notably, vessels wishing to enter the country must demonstrate a “compelling need” to conduct the repairs in New Zealand, and only the vessel’s crew will be permitted to enter the country—not necessarily the owner.