Updates on the COVID-19 pandemic from the Johns Hopkins Center for Health Security.

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EPI UPDATE The WHO COVID-19 Dashboard reports 71.35 million cases and 1.61 million deaths as of 4:00am EST on December 15. The global cumulative incidence surpassed 70 million cases on December 13. From the first reported COVID-19 case, it took 90 days for the global total to reach 1 million cases.
1 case to 10 million- 177 days
10 to 20 million- 44 days
20 to 30 million- 37 days
30 to 40 million- 31 days
40 to 50 million- 21 days
50 to 60 million- 17 days
60 to 70 million- 17 days

The WHO reported new records in terms of both weekly incidence and mortality. Weekly incidence was 3.4% higher than the previous week, the second consecutive week-to-week increase. Mortality increased for the eighth consecutive week, although only a moderate 0.8% increase over the previous week. Additionally, the WHO reported new daily records for both incidence and mortality on December 11, with 695,808 new cases and 13,033 deaths.

The US CDC reported 16.11 million total cases and 298,266 deaths. The US reported a new single-day record for daily incidence on December 11, with more than 244,000 new cases. It continues to appear as though US daily incidence is beginning to taper off toward a peak or plateau; however, we have likely still not yet begun to see any effects from Thanksgiving travel and gatherings. If the Thanksgiving holiday had major impact on the US epidemic, we expect to begin to see the early evidence over the next week or two.

In terms of mortality, the US is averaging 2,430 deaths per day, which corresponds to 1 US death every 36 seconds. To date, the US has only exceeded this rate for a 3-day period from April 19-21, at the very peak of the initial US surge and just days after New York City reported 3,700 previously unreported probable COVID-19 deaths from the onset of its epidemic. We expect the US to surpass 300,000 cumulative deaths in this afternoon’s CDC update. From the first US death reported on February 29, it took 46 days to reach 25,000 deaths. From there:
25k to 50k- 9 days
50k to 75k- 13 days
75k to 100k- 20 days
100k to 125k- 31 days
125k to 150k- 32 days
150k to 175k- 24 days
175k to 200k- 31 days
200k to 225k- 34 days
225k to 250k- 24 days
250k to 275k- 14 days
275k to 300k- 11 days

According to analysis published on the COVID Exit Strategy website, 34 states; Washington, DC; and Puerto Rico are reporting increasing COVID-19 incidence over the past 2 weeks. Notably, the daily incidence has more than doubled in 3 states over that period—California, Maine, and South Carolina—and another 12 are reporting increases of 50% or more. Most of the increasing trends are in states along the East and West Coasts and the South, whereas states in the middle of the country are declining. In fact, a number of states that were severely affected earlier in the autumn resurgence have peaked in terms of daily incidence and are now reporting considerable decreases, including Iowa, Minnesota, Nebraska, North and South Dakota, Wisconsin, and Wyoming. These states were more severely affected earlier in the current surge, so it is not surprising that they are peaking earlier. Additionally, Hawai’i moved up from Caution Warranted to Trending Poorly as a result of worsening incidence and other indicators.

According to analysis by the COVID Tracking Project, all but 3 states have reported record high daily incidence since the beginning of November, including 17 since last week. While the vast majority of states recently peaked or continue to report record-high and/or increasing incidence, regional differences are emerging here as well. The Midwest region is the only one to have passed a peak in daily incidence or hospitalizations, although mortality continues to increase across all 4 regions. The Midwest and South regions appear as though they may be at or approaching a peak in daily mortality, but more data are needed to better characterize the longer-term trends. Additionally, 13 states and Washington, DC, are reporting increasing hospitalizations over the past week, and another 13 are reporting positive trends but less than +10% cutoff to be classified as “Rising.” While the regional mortality may be beginning to turn in the Midwest, Iowa and North and South Dakota continue to report per capita daily mortality substantially higher than the rest of the country, on the order of 50% or higher than any other state.

The Johns Hopkins CSSE dashboard reported 16.55 million US cases and 301,264 deaths as of 11:30am EST on December 15.

US FDA AUTHORIZES PFIZER VACCINE On December 11, the US FDA issued an Emergency Use Authorization (EUA) for the Pfizer/BioNTech vaccine, which allowed Pfizer to begin distributing the first allotments of the vaccine nationwide. The FDA also published guidance for vaccinators—including storage, thawing, dilution, and dosing information—and recipients. The EUA specifically authorizes the vaccine for use in individuals aged 16 years and older, but as we covered previously, not everyone in this population will be immediately eligible for vaccination. Eligibility will be expanded slowly, starting with priority populations such as high-risk individuals and essential workers. The only contraindication listed in the vaccine information is a history of allergies to vaccine ingredients, although safety monitoring and reporting will be ongoing as the vaccination program unfolds in order to identify any additional conditions associated that could be associated with adverse events following vaccination. 

US VACCINE DISTRIBUTION & ADMINISTRATION On December 11-12, the US Advisory Committee on Immunization Practices (ACIP) met to approve its interim recommendations for use of the Pfizer/BioNTech SARS-CoV-2 vaccine, following the FDA’s issuance of an EUA. The content of the recommendations, published in the US CDC’s MMWR, provide an update to the initial interim guidance published on December 3. ACIP also updated the underlying evidence considered in developing the recommendations. ACIP recommended that the vaccine could be administered to those aged 16 years or older in the US, and that two doses should be administered 21 days apart. ACIP previously also stated that initial doses should be prioritized for healthcare personnel and long-term care facility residents in the first tier of recipients. Notably, the EUA included a provision for pregnant women to potentially be immunized.

The first shipments of the Pfizer/BioNTech vaccine have already been sent out from Pfizer’s facility in Kalamazoo, Michigan, as well as a distribution center in Wisconsin, and vaccination efforts began across the country. Most of the initial reports indicated that healthcare workers were among the first to be vaccinated, as major hospitals are better equipped than many locations to maintain the resource-intensive storage requirements, including that the vaccine be maintained at -112°F (-80°C). Many hospitals will serve as hubs to distribute vaccines locally for long-term care facilities (LCTFs), and there are reports that vaccinations have already commenced at some LCTFs as well.

VACCINE COMBINATIONS As initial doses of first generation SARS-CoV-2 vaccines are being distributed in some countries, discussions are already underway to optimize second generation vaccine formulations and dosing schedules. Last week, AstraZeneca announced that it is collaborating with the developers of Russia’s Sputnik V vaccine to determine whether administering a combination of the two vaccines could improve efficacy. Reportedly, the initial clinical trials of the combination vaccine would be held in Russia to assess this will begin in Russian adults. According to the press release issued by AstraZeneca, the UK government has already announced upcoming clinical trials to evaluate combinations of adenovirus-based vaccines, like those produced by AstraZeneca/Oxford University and Russia’s Gamaleya Research Institute, and mRNA vaccines, like those from Pfizer/BioNTech and Moderna; however, the AstraZeneca and Gamaleya Institute collaboration will evaluate a combination of two adenovirus-based vaccines.

Utilizing a combination of different vaccines for the same pathogen is called “heterologous boosting,” and it aims to improve both efficacy and accessibility. AstraZeneca indicated that the heterologous boosting approach could speed the process of completing the 2-dose regimen, particularly if the availability of some vaccines is limited; however, UK government health officials stated that the focus is on improving the immune response and not a response to limited supply.

Despite implementing “partial lockdown” measures in early November, Germany is strengthening restrictions ahead of the winter holidays. Germany’s daily incidence has increased tenfold since the beginning of October, and its cumulative incidence increased quadrupled over that time. The magnitude of this “second wave” spurred the German government to take further actions. In the previous partial lockdown, bars and restaurants were closed, while stores and schools remained open.

In this new “reinforced” lockdown, currently scheduled from December 16 to January 10, schools, retail stores other than grocery stores and supermarkets, and other non-essential businesses will be closed, in addition to bars and restaurants. Businesses that are mandated to close will receive financial support from the government, up to €500,000 (US$600,000) per month. Germany is also implementing household visiting restrictions, with some minor exceptions for Christmas. Gatherings will be limited to a maximum of 5 total individuals from 2 households. Over Christmas, including Christmas Eve, households may invite 4 additional people “from the closest family circle.” These celebratory exceptions do not apply to New Year’s Eve. Scheduled New Year’s events are being cancelled, and Germany banned the sale of fireworks. By entering this period of reinforced lockdown, German authorities are hoping to stave off another potential wave that could overwhelm its healthcare system and provide enough time for the European Medicines Agency to authorize a vaccine and vaccination efforts to commence.

Many areas of the UK are entering the highest tier of COVID-19 restrictions. All boroughs of London as well as areas of Essex and Hertfordshire in England will enter Tier 3 restrictions, which include limitations on indoor and outdoor gatherings and closures for non-essential businesses. A majority of England’s population, 34 million people, will be affected. Individuals not living in Tier 3 areas are advised not to travel to and from those areas. A number of the restrictions, including on indoor gatherings, will be relaxed for Christmas celebrations. The UK will permit individuals and families to form a “Christmas bubble”, which will allow individuals from up to 3 households to visit each other indoors and stay overnight. Travel restrictions will also be lifted to allow individuals to visit family members anywhere in the UK.

Like its neighbor Germany, the Netherlands is also strengthening “lockdown” restrictions ahead of the holiday season. The Dutch government decided to order renewed measures against COVID-19 following a sharp rise in cases over the last 2 weeks. Following a 50% decrease in daily incidence from its second peak, the Netherlands jumped back up 70% since December 1. Under the updated restrictions, non-essential businesses must close, schools must switch to remote learning, and gatherings are limited to 2 people, even outdoors. Notably, households will be permitted to have 3 guests indoors from December 24-26, not including children aged 12 years and younger. The Dutch government also outlined “crucial professions” that are permitted to continue in-person operations and noted that children of crucial workers may still attend primary school or after-care programs.

In contrast to some other European countries, France is taking steps to ease COVID-19 restrictions. After passing its second peak, France ended its “lockdown” today and relaxed some social distancing measures. Rather than a formal lockdown period, France is instituting an 8pm curfew that aims to limit transmission at gatherings at times when people may be less vigilant about implementing appropriate protections, such as physical distancing and mask use. After 8pm, most businesses will be directed to close, and individuals will need to carry official exemption certificates in order to be out in public. Violators could face fines of €135, and up to € 3,750 for repeat offenders. Bars, restaurants, and nightclubs are scheduled to remain closed until January 20. The French government will permit individuals and families to travel on December 24 but public gatherings will be prohibited. While the restrictions will be eased slightly for Christmas Eve, France intends to enforce the curfew on January 31, New Year’s Eve.

EUROPEAN MEDICINES AGENCY VACCINE AUTHORIZATION Following regulatory agencies in Canada, the UK, and the US authorizing the use of Pfizer and BioNTech’s SARS-CoV-2 vaccine, the European Medicines Agency (EMA) is set to complete its assessment by next week. The EMA’s human medicines committee (CHMP) received additional data yesterday and scheduled a meeting for December 21 to discuss its recommendations regarding a conditional authorization. Like in other countries, the official determination will be made by the EMA with strong consideration of the CHMP’s recommendations. The meeting was moved forward from December 29, but the CHMP is keeping the originally scheduled meeting on the calendar in the event it is needed. The timing of the CHMP meeting has been criticized as delayed, particularly in light of the authorizations already issued in Canada, the UK, and the US; however, EMA’s Executive Director, Emer Cooke, suggested that the other countries received the clinical trial data earlier than the EMA.

Reports emerged yesterday that documents related to Moderna’s application for conditional authorization for its candidate SARS-CoV-2 vaccine was accessed via a cyberattack on the EMA. The EMA was also attacked earlier in December, during which hackers gained access to documents related to the Pfizer/BioNTech vaccine as well. Reportedly, the Moderna documents did not include personally identifiable information for study participants.

REMDESIVIR & BARICITINIB Researchers conducting clinical trials under the Adaptive COVID-19 Treatment Trial 2 (ACCT-2) program published findings from a randomized, placebo-controlled clinical trial evaluating the effect of remdesivir and baricitinib combination therapy for COVID-19. The study, published in NEJM, included more than 1,000 participants divided approximately equally between patients treated with remdesivir and baricitinib and patients treated with just remdesivir (in combination with a placebo).

The primary analysis focused on time to recovery, and the researchers identified a slight but significant improvement among the treatment group. Patients who received the combination therapy recovered in an average of 7 days, compared to 8 days among the control group. Perhaps most notably, however, the researchers identified an improvement in recovery time from 18 days to 10 days among the 216 patients who received high-flow oxygen therapy or non-invasive ventilation. The researchers indicate that the faster recovery time among these patients with severe disease could be a result of reduced risk of hospital-acquired infections and thrombosis.

GUILLAIN-BARRÉ SYNDROME Researchers in the UK published findings from a study on Guillain-Barré syndrome (GBS) and COVID-19. GBS is a relatively rare neurological condition that can develop following various kinds of infections, including viral, and some have speculated that COVID-19 could be driving an increase in GBS. GBS can cause pain and numbness and even muscle weakness or paralysis in severe cases. If the weakness or paralysis affects the muscles responsible for breathing, it could be fatal, and patients could require mechanical ventilation.

The GBS study, published in Brain, found no causative association between GBS and COVID-19. The researchers compared GBS data during the UK’s first COVID-19 wave (March-May 2020) against GBS data from 2016-19. Like many other health conditions, reports of GBS decreased during the first wave, falling from 113-132 cases in March-May in 2016-19 to 56-93 cases in 2020. This could be a result of individuals delaying medical care during the UK’s “lockdown” or a reduction in transmission of other infections that could lead to GBS. The researchers also included seroprevalence data for SARS-CoV-2 infection among blood donors, and they estimate the risk of GBS to be approximately 0.016 cases of GBS per 1,000 cases of COVID-19. The researchers also evaluated patient-level data from 47 GBS cases reported in the UK, including 13 confirmed and 12 probable COVID-19 cases and 22 non-COVID-19 patients. They identified an increase in the use of intubation among GBS patients with COVID-19, which the researchers believe is “likely” due to the pulmonary effects of COVID-19 rather than increased severity of GBS presentation.

GBS has previously been identified following vaccination, with frequency estimates ranging from occasional to rare. Following influenza vaccination efforts in the US in 1976-77, reports of GBS in recently vaccinated individuals ultimately resulted in the suspension of vaccination activities, and this historical example has contributed to concerns about links between vaccination and GBS. In light of the UK and other countries commencing SARS-CoV-2 vaccination efforts, the research study was published alongside a commentary regarding the risk of GBS associated with SARS-CoV-2 vaccination. The commentary—authored by researchers from the Netherlands, Spain, the UK, and the US—called on health and elected officials to resist the urge to link GBS cases after vaccination to the vaccine. The researchers outline approximations for expected incidence of GBS under normal conditions, and they conclude that normal GBS incidence would result in more than 13,000 cases globally in the 10 weeks following a SARS-CoV-2 vaccination, without any effect at all from the vaccine. They use this analysis to highlight that many individuals will inevitably develop GBS, whether they are vaccinated or not, and a substantial portion of these cases will, by pure coincidence, develop in the period after vaccination. It is critically important to closely monitor for adverse events, but it is just as important to ensure that we do not unnecessarily suspend vaccination activities as a result of preconceived notions regarding the risk of GBS or other conditions.