Covid-19 Updates & Info

[MJ2004]

New diabetes cases linked to covid-19
Researchers don’t understand exactly how the disease might trigger Type 1 or Type 2 diabetes, or whether the cases are temporary or permanent. But 14 percent of those with severe covid-19 developed a form of the disorder, one analysis found.

That is disturbingly high. It'd be interesting to see if that number remained steady with in-depth research.

Not sure why this doesn't mention it, but covid was thought of as a respiratory disease early on because of all the lung issues, but many are increasingly classifying it as a vascular disease. In that context, the sudden onset of diabetes makes a good deal more sense.

Agree - 14% is disturbingly high.

I think that trying to think of it as a respiratory or a vascular disease is a mistake. It reminds me of autoimmune diseases where multiple parts of the body are attacked at once. It is causing severe inflammation and damage in many body organs simultaneously.

[ponchi101]

Remember we are only one year into this. It took years to finally truly figure out what AIDS really was.
By the time this is over (if it is ever over) this thing will have mutated into some form of virus that we have not seen before.
And remember when I stupidly joked about Covid20 and Covid21? Well, P, you and your big mouth.

[mmmm8]

Agree - 14% is disturbingly high.

I think that trying to think of it as a respiratory or a vascular disease is a mistake. It reminds me of autoimmune diseases where multiple parts of the body are attacked at once. It is causing severe inflammation and damage in many body organs simultaneously.

This really seems to be the case.

[dryrunguy]

Here's the latest Situation Report. I was especially struck by the demographics of those already vaccinated in the U.S.

::

EPI UPDATE The WHO COVID-19 Dashboard reports 102.94 million cases and 2.23 million deaths as of 11am EST on February 2. The weekly global incidence decreased for the third consecutive week, down to 3.63 million new cases. This is a decrease of nearly 15% compared to the previous week, and it is the lowest weekly total since late October. Weekly global mortality also decreased nearly 4% compared to the previous week, down to 93,803 deaths. Considering the reporting interruptions over the winter holidays, it is unclear exactly when the actual global incidence peaked; however, the decrease in mortality could be an early indication of a longer-term trend corresponding to decreases in incidence starting 2-4 weeks ago.

Our World in Data reports that 101.31 million vaccine doses have been administered globally, a 48% increase since this time last week.

UNITED STATES
The US CDC reported 26.03 million total cases and 439,955 deaths. The US is currently averaging 3,145 deaths per day, and it could surpass 450,000 cumulative deaths in the next 3-4 days.

National-level daily incidence continues to decrease, down from nearly 250,000 new cases in per day in mid-January to around 150,000. While the daily incidence continues to decrease, the current average is still more than double the peak of the summer surge. Daily mortality is also beginning to show signs of declining. The US has reported decreasing daily mortality for 5 consecutive days, down 5% since January 26. Additional data are needed to determine if this is an early indication of a longer-term trend, but a decrease spanning multiple days is an encouraging sign.

US Vaccination
The US CDC reported 49.94 million vaccine doses distributed and 32.22 million doses administered. The US has administered 64.5% of the distributed doses, which is an increase of more than 10 percentage points from Friday’s update (54.1%). In total, 26.02 million people (approximately 7.9% of the US population) have received at least 1 dose of the vaccine, and 5.93 million (1.8%) have received both doses. The US is now averaging 1.36 million doses administered per day, a 20% increase from the previous week. The breakdown of doses by manufacturer remains relatively even, with slightly more Pfizer/BioNTech doses administered (17.36 million; 54%) than Moderna (14.76 million; 46%).

The CDC moved data for vaccination at long-term care facilities (LTCF) to its own dashboard. A total of 3.75 million doses have been administered through the Federal Pharmacy Partnership for Long-term Care Program*, covering 3.14 million individuals with at least 1 dose and 594,857 with 2 doses. The dashboard breaks down the doses by those administered to LTCF residents and those administered to staff. Based on the available data, approximately 60% of the doses have gone to residents and 40% to staff.
*The dashboard only includes data for doses administered through the federal program. It does not report data from West Virginia, which opted out of the program.

The Johns Hopkins CSSE dashboard reported 26.35 million US cases and 444,336 deaths as of 1:30pm EST on February 2.

RUSSIAN VACCINE Sputnik V, Russia’s primary vaccine candidate, appears to be safe and effective in preventing symptomatic COVID-19, based on preliminary analysis of Phase 3 clinical trial data published in The Lancet. The clinical trials included nearly 20,000 participants, with 75% randomly assigned to receive the vaccine. The researchers identified 16 cases of COVID-19 among the treatment group (14,964 participants) and 62 cases among the placebo group (4,902), corresponding to an overall efficacy of 91.6% in terms of preventing COVID-19 disease, similar to the results for the Pfizer-BioNTech and Moderna vaccines. Notably, the vaccine also exhibited 91.8% efficacy among adults over the age of 60, and no moderate or severe cases of COVID-19 were reported among the vaccinated participants. No serious adverse events were determined to be associated with the vaccine.

The Sputnik V vaccine is administered in 2 doses, administered 21 days apart. It requires the temperature to be maintained at approximately 0°F (-18°C), with short-term storage at 36-46°F (2-8°C). In contrast, ultra-cold storage (approximately -80°F or -62°C) is required for the Pfizer-BioNTech vaccine.

The Russian government came under criticism in August 2020 after making the Sputnik V vaccine candidate available to the public before Phase 3 clinical trials were completed. More than a dozen other countries have already authorized the use of the Sputnik V vaccine.

US VACCINATION The US CDC COVID-19 Response Team published data from the early stages of SARS-CoV-2 vaccination efforts in the US. The first study, published in the CDC’s MMWR, described demographic characteristics among those vaccinated in the first month—December 14, 2020 to January 14, 2021. The researchers analyzed age, sex, and race/ethnicity data for nearly 13 million individuals who received at least 1 dose of the vaccine. The majority of those vaccinated were older adults, with 55% aged 50 years and older, including 13.4% aged 65-74 years and 15.6% aged 75 years and older. Additionally, 63% of those vaccinated were female.

Among 6.7 million individuals with race/ethnicity data, the majority (60.4%) were White*, compared to 11.5% Hispanic/Latinx, 5.4% Black*, 6.0% Asian*, and 2.3% American Indian, Alaskan Native, Native Hawaiian, or Other Pacific Islander* and 14.4% were listed as Multiple races/ethnicities or Other. The researchers indicate that the demographic distributions appear to largely reflect those of the earliest priority populations outlined by the CDC’s Advisory Committee on Immunization Practices, including LTCF residents and healthcare workers. Notably, however, the proportion of Black vaccinees was lower than would be expected considering the racial/ethnic distribution these priority groups.
*Non-Hispanic.

The second article, also published in the CDC’s MMWR, discussed vaccination coverage among LTCF residents and staff. The researchers evaluated data on nearly 1.3 million individuals vaccinated through the CDC Pharmacy Partnership for Long-Term Care Program from December 18, 2020 to January 17, 2021. Among these individuals, 713,909 were residents and 582,104 were facility staff. In total 12,702 facilities participated in the program, of which 11,460 (90.2%) conducted at least one on-site vaccination clinic. This effort provided at least 1 dose of the vaccine to an estimated 77.8% of residents at these facilities, but only 37.5% of staff. Due to a combination of factors—including age, underlying health conditions, and prolonged close contact in congregate settings—LTCF residents are at elevated risk for infection, severe disease, and death, so it is important to achieve high vaccination coverage at these facilities.

In addition to state and local governments, tribal nations are also scaling up vaccination efforts. The Navajo Nation, one of the most severely affected tribal nations during the US epidemic (29,860 cases), eased its weekend curfew in an effort to expand vaccination. The principal challenges are addressing vaccine hesitancy, particularly among older adults who are at elevated risk, and reaching individuals who live in rural areas that are unable or unwilling to travel to get vaccinated, especially during adverse winter weather conditions. Proactive effort by tribal leadership and health workers has driven substantial progress in terms of vaccination coverage. To date, Navajo Nation has administered at least 1 dose of SARS-CoV-2 vaccine to more than 20% of its population, higher coverage than any US state or territory.

VACCINATION PROTESTS Dodger Stadium in Los Angeles, California, is currently serving as one of the largest mass vaccination sites in the US, but protests by anti-vaccination groups caused the site to be temporarily shut down on Saturday when protesters blocked the entrance to the stadium. Fortunately, the disruption did not result in the cancellation of any appointments, but Governor Gavin Newsom emphasized that protests will not be deterred by protests. Protesters reportedly attempted to intimidate individuals waiting in line and spread misinformation about COVID-19 and the vaccine. New safety measures at Dodger Stadium will clearly delineate where protesters are permitted to be in order to prevent further disruptions to vaccination operations.

GERMANY On January 29, the European Commission issued a conditional marketing authorization (CMA) for the use of the AstraZeneca-Oxford University SARS-CoV-2 vaccine in adults aged 18 and older. While the announcement acknowledged that the clinical trials primarily included adults aged 18-55 years, the CMA did not include an upper age limit. In a decision stemming from a concern about insufficient efficacy data in older adults, Germany authorized the AstraZeneca-Oxford vaccine only for adults aged 18-64. Currently, vaccine eligibility in Germany is limited to residents and staff of long-term care facilities, adults aged 80 years and older, and frontline healthcare workers. Because the AstraZeneca-Oxford vaccine is not authorized for many high-risk individuals due to Germany’s age restrictions, Germany will reportedly review its eligible populations and prioritize use of that particular vaccine in younger healthcare workers and LTCF staff.

Germany has struggled with a slow start to its vaccination campaign, and Chancellor Angela Merkel reportedly met with state governors, EU leadership, and representatives from the pharmaceutical industry yesterday to identify mechanisms to speed progress toward national vaccination coverage. Following the meeting, Chancellor Merkel indicated that Germany still anticipates being able to vaccinate its entire population by September 2021, even if no additional vaccines are authorized for use.

Like many countries around the world, Germany recently instituted travel restrictions in response to emerging, highly transmissible SARS-CoV-2 variants. Notably, non-German citizens arriving from “areas of variant of concern”—currently Brazil, Eswatini, Ireland, Lesotho, Portugal, South Africa, and the UK—will not be permitted to enter the country, even with a recent negative SARS-CoV-2 test. Individuals who are eligible to enter—including German citizens and residents—and recent travel to “high incidence areas” or “virus variant areas” must provide proof of a negative test prior to entry, and all individuals with recent travel to “risk areas”—which covers most countries, including most in Europe—must be tested within 48 hours after arrival. All travelers arriving from places identified as at risk, high-incidence, or variant areas are required to self-quarantine for 10 days after they arrive. The quarantine can potentially be terminated after 5 days, with a negative test. The new restrictions are expected to remain in place through at least February 17.

DRC DRONE VACCINE DISTRIBUTION Drones have previously been used for the delivery of medical supplies, including vaccines, to areas that are remote or difficult to access. The Democratic Republic of the Congo (DRC) recently announced a partnership between VillageReach, Swoop Aero, and the DRC Ministry of Health—“Drones for Health”—will use drone to promote equitable access to healthcare for half a million people in remote communities of the Equateur province. In addition to standard medical supplies, the new program is expected to support SARS-CoV-2 vaccination efforts in the country. These drones will be used to deliver medicine and other supplies to 75 health facilities in the province.

REFUGEES & DISPLACED POPULATIONS Refugees are among the most vulnerable populations in the world, particularly in the midst of a pandemic. Being displaced from their homes and separated from community support systems, refugees and other displaced populations often live in congregate settings without access to clean water or proper sanitary equipment, which exacerbates risk of transmission and severe disease. Furthermore, displaced populations face significant barriers in terms of accessing healthcare, and medical organizations that work with these populations are often underfunded and overwhelmed. King Abdullah II Ibn Al Hussein of Jordan recently announced that the Jordanian government initiated vaccination operations for refugee population in the country. King Abdullah viewed it as part of Jordan’s “global responsibility” and “moral duty” to protect the most vulnerable from COVID-19. The UN Refugee Agency (UNHCR) applauded Jordan’s initiative to include displaced populations in its vaccination program and encouraged other countries to follow Jordan’s example.

In recognition of the disproportionate COVID-19 burden among immigrant populations, many of whom are racial and ethnic minorities, the US Department of Homeland Security (DHS) is committing resources to ensure equal access to SARS-CoV-2 vaccines for undocumented immigrants. A statement issued by DHS emphasized the “public health imperative” in ensuring access to vaccination, regardless of immigration status. While many undocumented immigrants are not refugees, they may face similar stigma and barriers to accessing public health and healthcare. As part of this effort, the Federal Emergency Management Agency will coordinate vaccination clinics that aim to reach “underserved and rural communities,” and federal immigration officials, including Immigration and Customs Enforcement and Customs and Border Protection, “will not conduct enforcement operations at or near vaccine distribution sites or clinics” in order to encourage participation by vulnerable individuals and communities.

PREGNANT WOMEN On January 26, the WHO updated its guidance on the Moderna SARS-CoV-2 vaccine to include pregnant women. Previously, the WHO recommended against vaccinating pregnant women unless they were at elevated risk, which conflicted with recommendations published by the US CDC. While the current iterations of both sets of guidelines do not explicitly recommend vaccinating pregnant women, both note that there is currently no evidence to suggest that the vaccine poses safety concerns for pregnant women.

A study published in JAMA: Pediatrics provides evidence that pregnant women may be able to pass IgG antibodies against SARS-CoV-2 to their fetus. The study involved 1,417 women who recently gave birth. Among 83 mothers with detectable SARS-CoV-2 antibodies, 72 (86.7%) transferred IgG antibodies to their fetus—as detected in the newborns’ cord blood. IgM antibodies were not detected in any cord blood specimens, and antibodies were not detected in any infants born to mothers without detectable antibodies. The concentration of antibodies in the cord blood was significantly correlated with the concentration in the mother, but the antibodies were successfully transferred by mothers who exhibited symptomatic disease and asymptomatic infection. The study did not explicitly evaluate the ability to transfer antibodies developed as a result of vaccination; however, the researchers indicate that the results align with similar studies on transplacental transfer of vaccine-conferred antibodies for other diseases. Further research is necessary to determine the recommended timing for vaccination of pregnant women in order to achieve sufficient transplacental transfer of SARS-CoV-2 antibodies to the fetus.

US ECONOMIC STIMULUS With the Democratic party now in control of the US House of Representatives, Senate, and White House, pressure is increasing to negotiate additional federal economic relief for the COVID-19 epidemic. US President Joe Biden announced his proposal for a new COVID-19 economic stimulus and recovery package, the American Rescue Plan, which includes US$1.9 trillion in funding. The package includes support for SARS-CoV-2 testing and vaccination efforts ($415 million) and small businesses ($440 million). It also includes $1 trillion in direct support for individuals and families, including another round of stimulus checks and increased and extended unemployment benefits. Additionally, the package includes broader provisions to increase the federal minimum wage and expand access to affordable childcare and healthcare.

While the Democratic party holds a majority in the Senate (with the tie-breaking vote from Vice President Kamala Harris), there are limited options available to pass a funding bill without some degree of Republican support. In hopes of stimulating bipartisan negotiations, 10 Republican Senators visited the White House to outline an alternate funding package, which totals $618 billion. The Republican proposal would include smaller and more targeted direct stimulus checks for individuals; maintain the current $300 federal supplemental unemployment benefits through June, as opposed to $400 through September in the White House plan; and reduce support for schools from $170 billion in the White House plan to $20 billion. The Republican plan would also eliminate funding to expand the national public health workforce; $350 billion in support to state, local, and tribal governments; subsidies for health insurance premiums; and the minimum wage increase. The initial meeting was reportedly productive, and there appears to be interest on both sides to continue negotiations.

As we have covered previously, the large-scale response efforts in many jurisdictions—including testing, surveillance, and vaccination—have posed major financial challenges to jurisdictions across the country. An investigation by STAT News found that senior US government officials under the Trump Administration “actively lobbied Congress to deny state governments any extra funding for the Covid-19 vaccine rollout.” STAT News reports that the primary point of contention reportedly dealt with the speed with which states were using previous federal funding allocations for COVID-19 response.

EMERGING VARIANTS As scientists continue to monitor emerging SARS-CoV-2 variants of concern (VOCs), researchers are identifying new mutations. Of particular concern is the E484K mutation, which consists of an amino acid change in the spike receptor binding domain of the SARS-CoV-2 virus. This change appears to result in increased binding strength of the spike protein to the ACE2 receptor, which is how the virus enters human cells. Notably, the E484K mutation appears to result in increased transmissibility and resistance to monoclonal antibody treatments. This mutation has been identified in several variants of SARS-CoV-2 in different geographic areas, including Brazil and the UK, and it appears to be increasing in prevalence, which suggests increased fitness compared to other mutations. The fact that this mutation has been independently acquired in multiple locations and variants indicates that the E484K changes in the spike gene are broadly advantageous to SARS-CoV-2 and may continue to arise in subsequent variants.

Aside from the E484K mutation, scientists monitoring the B.1.1.7 VOC also must track its prevalence and incidence among the population. Since whole genome sequencing to detect the Δ69-70 mutation is costly and time consuming, the UK’s NERVTAG expert group used existing laboratory PCR-based testing to track the variant. Specifically, the Δ69-70 mutation in the spike gene causes S gene target failure (SGTF) in the ThermoFisher TaqPath assay, resulting in a false negative PCR test from a known positive sample. By looking for SGTF in known positive samples (confirmed by other PCR assays), researchers can monitor the extent of the Δ69-70 mutation in the B.1.1.7 VOC without the need for time- and resource-intensive whole genome sequencing methods.

VACCINE DEVELOPMENT & TESTING Clover Biopharmaceuticals, a Chinese company developing a SARS-CoV-2 vaccine candidate, announced that it is moving forward with Phase 2/3 clinical trials for its candidate SARS-CoV-2 vaccine using an adjuvant manufactured by Dynavax, rather than one produced by GlaxoSmithKline (GSK). According to a press release from Clover, the two adjuvants induced similar immune response in Phase 1 clinical trials, but Clover selected the Dynavax adjuvant for its forthcoming Phase 2/3 clinical trials due to concerns about production capacity for the GSK product. Clover anticipates vaccine production capacity of “hundreds of millions of doses in 2021” and ultimately as high as 1 billion doses per year. Clover expects to have preliminary data available from the Phase 2/3 trials by the middle of 2021.

https://covid19.who.int/

[shtexas]

I have seen a lot of Facebook comments claiming the vaccines are not FDA approved, may give you AIDS, and will change your DNA.

[ponchi101]

Facebook has to be banned. It is getting to that point. If somebody were to quantify how much harm it does, it would be clear.
---0---
I am still not taking the Sputnik.
Here: vaccination to begin on Feb 20th. A five delay over the initial plan of Feb 15th.
I will get vaccinated by Jan 2022. You'll see.

[Suliso]

I will get vaccinated by Jan 2022. You'll see.

Optimist

[ti-amie]

His Twitter bio:
Zach Buchanan @ZHBuchanan
Diamondbacks reporter for @TheAthleticAZ and prospect features for @TheAthleticMLB
. I watch a distressing amount of television.

[Suliso]

Just learned that in Latvia available vaccine will be distributed first to the usual priority groups and then the reminder via a monthly lottery (first dose, second appointment is automatic). Haven't heard such an approach anywhere else.

[Deuce]

Just learned that in Latvia available vaccine will be distributed first to the usual priority groups and then the reminder via a monthly lottery (first dose, second appointment is automatic). Haven't heard such an approach anywhere else.

How many tickets is each person permitted to have?

[ti-amie]

[ponchi101]

Solution:
Start vaccination. Vaccinate the people that want to get the vaccine. By September, when you will have sufficient people already vaccinated, pass a bill that allows insurance companies NOT TO PAY FOR YOUR TREATMENT if you refused the vaccine.
Other than that, they can so drop dead as far as I am concerned.
(Excluding seniors with cognitive impairment, who most likely will be vaccinated or not depending on their children's decisions)

[ti-amie]

[dryrunguy]

The latest Situation Report. I only skimmed it, but saw something about a strike by health care workers in Myanmar.

::

EPI UPDATE The WHO COVID-19 Dashboard reports 104.37 million cases and 2.27 million deaths as of 11am EST on February 5.

Our World in Data reports that 119.48 million vaccine doses have been administered globally, a 65% increase since this time last week.

According to data compiled by Our World in Data, at least 65 countries have initiated SARS-CoV-2 vaccination campaigns. The majority of these countries are in Europe and North America, although vaccination efforts are starting in Africa, South America, South and Southeast Asia, and the Eastern Mediterranean region. In terms of total doses administered, the US is #1 globally (35.2 million), followed by China (31.2 million), the UK (11.0 million), Israel (5.3 million), and India (5.0 million). In total, 15 countries have administered 1 million or more vaccine doses, and 42 have administered more than 100,000.

Because some individuals have only received the first dose while others have received both, it is difficult to determine the proportion of a country’s population with full coverage. The doses administered per capita, however, can provide insight into the progress toward full coverage. Full coverage with 2 doses would correspond to 200 doses per 100 population, so with that in mind, we can estimate the proportion of those doses that each country has administered so far. On a per capita basis, Israel is #1 globally with 61.7 doses administered per 100 population, which corresponds to approximately 30.8% of its way toward full coverage. The United Arab Emirates (UAE) is #2 with 34.8 doses per 100 population (19.5%), followed by Seychelles (37.7; 18.9%), the UK (16.2; 8.1%), and the US (10.6; 5.3%).

Broken down by continent, Asian countries have reported the most cumulative doses administered, with 49.77 million. Asia is followed by North America (36.98 million), Europe (28.44 million), South America (3.82 million), and Africa (390,160). In Asia (including the Eastern Mediterranean region), China represents the majority (64.2%) of the doses administered, which is not surprising, considering that it initiated vaccination months before most other countries. China is followed by Israel (10.7%), India (10.0%), the United Arab Emirates (7.7%), and Turkey (5.0%). The North American total is driven principally by the US, which is reporting more than 95% of the administered doses. Canada, Costa Rica, Mexico, and Panama have also started vaccinations. Similarly, Brazil is driving the South American total, with more than 80% of the administered doses. Brazil is followed by Argentina (11.6%) and Chile (7.6%). In Europe, the doses the UK accounts for slightly less than 40% of the total, followed by Germany (10.5%), Italy (8.2%), Spain (6.7%), and France (6.6%). Data are only available for 4 African countries—Algeria, Egypt, Morocco, and Seychelles. Morocco has reported approximately 90% of the doses administered, followed by Seychelles with 10%.

UNITED STATES
The US CDC reported 26.40 million total cases and 449,020 deaths. The daily incidence continues to fall, down to 134,523 new cases per day—a 46% decrease from the peak on January 8 (248,706). The daily mortality continues to decrease as well. The US is currently averaging 3,056 deaths per day, a decrease of 8% since January 26 (3,316). The US will almost certainly surpass 450,000 cumulative deaths in this afternoon’s update:
1 death to 50k- 55 days
50k to 100k- 33 days
100k to 150k- 63 days
150k to 200k- 55 days
200k to 250k- 58 days
250k to 300k- 25 days
300k to 350k- 20 days
350k to 400k- 16 days
400k to 450k- 16 days

US Vaccination Effort
The US CDC reported 57.49 million vaccine doses distributed and 35.20 million doses administered. The US has administered 61.2% of the distributed doses, which is a slight decrease from Tuesday (64.5%). In total, 27.91 million people (approximately 8.5% of the US population) have received at least 1 dose of the vaccine, and 6.93 million (2.1%) have received both doses. The average daily doses administered fell sharply over the past several days, down from a high of 1.4 million doses per day on January 30 to 892,946 on February 3, a decrease of 36%. The breakdown of doses by manufacturer remains relatively even, with slightly more Pfizer-BioNTech doses administered (18.84 million; 54%) than Moderna (16.26 million; 46%).

A total of 4.21 million doses have been administered at long-term care facilities (LTCFs) through the Federal Pharmacy Partnership for Long-term Care (LTC) Program*, including residents and staff. This covers 3.40 million individuals with at least 1 dose and 796,324 with 2 doses. Approximately 60% of the doses have gone to residents and 40% to staff.
*The dashboard only includes data for doses administered through the federal program. It does not report data from West Virginia, which opted out of the program.

The Johns Hopkins CSSE dashboard reported 26.72 million US cases and 456,900 deaths as of 1:30pm EST on February 5.

PANDEMIC FORECASTING In the White House’s National Strategy for the COVID-19 Response and Pandemic Preparedness, published in January, US President Joe Biden included the need for a National Center for Epidemic Forecasting and Outbreak Analytics “to modernize global early warning and trigger systems to prevent, detect, and respond to biological threats.” Under current systems, there are limited federal resources for epidemiological modeling, and independent disease modelers, including from academic institutions and private sector think tanks across the country, are often called upon to support the government’s preparedness and response efforts, typically as volunteers. Dr. Caitlin Rivers, from the Johns Hopkins Center for Health Security, and Dr. Dylan George, Vice President of In-Q-Tel, have advocated for this capacity for years, and the US government has finally heeded their call for action. President Biden directed federal agencies to develop plans to establish the center in an executive order issued on his second day in office.

The National Center for Epidemic Forecasting and Outbreak Analytics would provide a service similar to weather forecasting, except for endemic and epidemic diseases. COVID-19 will certainly not be the last major disease threat we face, and epidemiological and statistical analysis will be critical to rapidly identifying the emergence of outbreaks and epidemics and providing elected and health officials with the information needed to identify, implement, and adapt appropriate response activities. Funding under the proposed American Rescue Plan would support expanded testing and analytic capabilities during the COVID-19 response, including for genomic sequencing to address the threat of emerging variants, but longer-term investment is needed to embed the type of analytic capacity in the federal government, where it can inform national policy and response to epidemic events.

VACCINATION DOSE SCHEDULE & TRANSMISSION RISK
A study (preprint for The Lancet) of data from the Phase 3 clinical trials of the AstraZeneca-Oxford University vaccine evaluated vaccine efficacy after a single dose and for alternate timing for the booster dose. Notably, the UK adapted the timing for the booster dose from 4 weeks after the first dose—which is how the vaccine was designed to be administered and the timing used for clinical trials—to 12 weeks in an effort to provide the first dose to as many people as possible. This study assessed the vaccine’s efficacy in participants who received the 2 doses between 4 and 12 weeks apart.

The researchers found that the efficacy after the first dose did not wane in the first 12 weeks. A single dose of the vaccine was 76% efficacious in preventing symptomatic COVID-19 disease in the first 90 days after vaccination, although it was associated with a substantial decrease in efficacy with respect to preventing asymptomatic infection. Notably, however, the additional asymptomatic infections could potentially be among participants who would have otherwise developed COVID-19 symptoms. Additionally, the efficacy in preventing symptomatic disease was higher in participants who received the booster dose later than in those who received it earlier. Vaccine efficacy was 82.4% among participants who received their booster dose 12 weeks or longer after the first dose, compared to 54.9% in those who received their 2 doses less than 6 weeks apart. These results provide support for vaccination plans that delay the booster dose beyond the intended 4 weeks, considering that the immunity conferred after the first dose appears to be relatively stable over the first several months and the overall protection appears to increase with an increased time between the prime and booster doses.

The researchers also found that vaccination was associated with an overall reduced risk of infection—54.9% efficacy for 2 doses and 67% efficacy for 1 dose—which provides evidence that the vaccine could also provide protection against SARS-CoV-2 transmission. The role of SARS-CoV-2 vaccines in mitigating transmission risk remains uncertain, but these findings provide a promising indication that vaccination could reduce community spread of the virus, which would be a major tool to bring the pandemic under control.

J&J EUA SUBMISSION Yesterday, Johnson & Johnson (J&J) submitted an application to the US FDA for an Emergency Use Authorization (EUA) for its SARS-CoV-2 vaccine, developed in collaboration with Janssen Biotech. The US FDA announced that it will review the submission over the coming weeks, and it will convene a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 26 to discuss the vaccine’s safety and efficacy data. The FDA did not commit to a timeline for ruling on the EUA submission; however, it will “review the request as expeditiously as possible” following the VRBPAC meeting. As with the previous vaccines, the FDA intends to publish relevant data in the days prior to the VRBPAC meeting. J&J announced interim results from the Phase 3 clinical trials in a press release issued on January 29, but the full dataset or final analyses have not yet been released publicly or subjected to peer review. In addition to the US FDA, J&J intends to submit an application for a Conditional Marketing Authorisation (CMA) to the European Medicines Agency “in the coming weeks.”

J&J’s most recent press release indicates that it expects to be able to begin shipping vaccine doses “immediately following authorization.” The company expects to provide 100 million doses by mid-2021, but it did not indicate how much is currently available. Multiple news media reports indicate that the initial supply is expected to be relatively low. The J&J-Janssen vaccine utilizes a single dose, which provides an advantage over existing vaccines in terms of the potential to speed vaccination operations. And while the J&J-Janssen vaccine does require moderately low freezing temperatures (-4°F; -20°C) for long-term storage, it can be stored for up to 3 months at normal refrigeration temperatures (6°F–46°F; 2°-8°C), which could facilitate distribution and on-site storage at vaccination clinics.

COVAX VACCINE ALLOCATION On February 3, Gavi published interim SARS-CoV-2 vaccine allocation for the COVAX facility. The interim plan includes estimated quantities and timeline for vaccine distribution of the Pfizer-BioNTech and AstraZeneca-Oxford University vaccines to low- and middle-income countries eligible to receive doses through the COVAX effort. As we have covered previously, COVAX is a multilateral program to pool funding in an effort to help lower-income countries compete against wealthier countries in terms of purchasing doses of SARS-CoV-2 vaccines. In total, the interim plan estimates that 336 million doses of the AstraZeneca-Oxford vaccine and 1.2 million doses of the Pfizer-BioNTech vaccine will be distributed in the first half of 2021.

Due to the ultra-cold temperatures required for the Pfizer-BioNTech vaccine, those doses were only allocated to countries that requested early delivery of that vaccine and were determined to be capable of maintaining the cold chain. The available inventory was distributed relatively evenly across the eligible countries, with the aim of achieving full coverage for at least 3% of the population for each country in order to provide protection for the most vulnerable individuals (eg, healthcare workers). On average, the national allocations cover 3.3% of the countries' respective populations.

Of the 190 eligible countries, 145 are included in the earliest round of vaccine allocations, and delivery is expected to begin as early as late February and progress through the first half of 2021. The estimates aim to provide countries with an approximate quantity of doses in order to enable them to implement more concrete plans for national vaccine distribution and administration logistics and operations. The interim guidance notes that the AstraZeneca-Oxford vaccine has not yet received an Emergency Use Listing (EUL) from the WHO, but that evaluation process is in progress.

SARS-CoV-2 TRANSMISSION The scientific community is still uncovering the full picture of SARS-CoV-2 transmission dynamics. A study published in The Lancet: Infectious Diseases analyzed SARS-CoV-2 transmission among clusters in Catalonia, Spain, to understand the relationship between viral load and transmission risk. The researchers utilized participant data from a previous clinical trial, and they identified 314 COVID-19 patients that met their inclusion criteria. Among those patients, 282 had at least 1 contact (753 total contacts). The index patients infected 125 secondary cases, corresponding to a secondary attack rate of 17%. The researchers identified a statistically significant association between viral load in the index patients and the subsequent secondary attack rate. Among index patients with the lowest viral load, index patients exhibited a secondary attack rate of 12%, compared to 24% among the highest group. The researchers estimate that the odds of secondary transmission increase 30% for every log(10) increase in viral load. Additionally, the study found increased likelihood that secondary cases would develop COVID-19 symptoms associated with increased viral load in the index patients (aHR of 1.12 per log(10) increase in viral load). While further research is needed to more fully characterize the factors associated with transmission, this study provides evidence that the index patient’s viral load could be a major driver of secondary transmission risk and potentially disease severity in secondary cases.

An editorial published in Nature discusses the need to shift focus away from surface decontamination as a mechanism to reduce SARS-CoV-2 transmission risk. Multiple studies have found that transmission of SARS-CoV-2 via contaminated surfaces, or fomites, is relatively rare compared to respiratory transmission via droplets or aerosols. Despite the evidence supporting respiratory exposure as the overwhelming driver of community transmission, numerous public health entities, including the WHO and US CDC, continue to emphasize the importance of surface decontamination, which can cause confusion among the public regarding transmission risk and appropriate protective measures. Notably, surface decontamination efforts, while highly visible and easy to recognize, are costly and likely not effective means of reducing transmission risk. The editorial calls for increased focus on improving ventilation and air filtration capacity to reduce respiratory exposure. Additionally, proper physical distancing and face mask use remain key tools in mitigating exposure and transmission risk for individuals.

GSK-CUREVAC VACCINE CANDIDATE GlaxoSmithKline (GSK) announced a partnership with German biotech company CureVac to develop a new, multivalent SARS-CoV-2 vaccine and manufacture CureVac’s first generation vaccine candidate. The joint vaccine development effort aims to target emerging SARS-CoV-2 variants, with the goal of making a product available in 2022. Under the new agreement, GSK will also manufacture up to 100 million doses of CureVac’s existing vaccine candidate in 2021, which is currently in Phase 2b/3 clinical trials in Europe and Latin America. Interim data from the ongoing trials are expected sometime in the first quarter of 2021.

TAIWAN VACCINATION The Taiwanese government is preparing for its national SARS-CoV-2 vaccination effort, but the source of its doses remains uncertain. Like many countries, Taiwan is currently awaiting delivery for doses it purchased months ago from multiple sources. Taiwan has largely managed to contain COVID-19, but health officials are responding to its first outbreak in months. Notably, Taiwan did not report a single domestic case between April 2020 and January 2021. Multiple Taiwanese vaccine candidates are in clinical trials, but the most advanced have not yet completed Phase 2 trials. The Taiwanese government has taken multiple approaches to securing vaccines, including COVAX facility led by the WHO and Gavi. Reportedly, Taiwan is experiencing problems obtaining doses from Western countries, potentially as a result of opposition by the Chinese government. Taiwan’s Minister of Health has reportedly expressed opposition to importing SARS-CoV-2 vaccines developed in China, due in part to an existing policy that prohibits importing vaccines and other “biological products” from China. Additionally, there is some uncertainty regarding the vaccines’ efficacy and safety data.

Notably, the interim COVAX allocation plan published by Gavi indicates that 1.3 million doses of the AstraZeneca-Oxford vaccine will be allocated to non-UN member states, potentially including Taiwan; however, the final determination will not be made until after the WHO issues an Emergency Use Listing (EUL). There is resistance to import Chinese made vaccines due to policies the shipment of biological products from China. In an effort to contain the ongoing outbreak in the absence of a vaccine, Taiwan is placing as many as 5,000 at-risk individuals into quarantine.

MYANMAR PROTESTS Following Monday’s military coup d’etat in Myanmar, staff from more than 70 hospitals and medical departments across 30 towns have stopped work in protest. Protesting healthcare workers are wearing red ribbons, and the Myanmar Civil Disobedience Movement issued a statement on February 3 indicating that they will not work for the new military government. According to one doctor, many who volunteered to support the COVID-19 response did so were inspired by Aung San Suu Kyi, leader of Myanmar’s National League for Democracy, who was deposed during the coup. The protest by healthcare workers has raised concerns about Myanmar’s new vaccination campaign, which started in late January, just days before the coup.

EASTERN MEDITERRANEAN REGION Earlier this week, a number of countries in the Eastern Mediterranean region announced new COVID-19 restrictions. For the most part, the Eastern Mediterranean region has avoided high COVID-19 mortality experienced by countries in other parts of the world, but recent increases in daily incidence prompted concerns about another COVID-19 surge. In response to the increasing transmission, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates implemented new restrictions on gatherings, including in public and at events like weddings and funerals; the operations of businesses, including retail stores and shopping malls, restaurants and bars, gyms and fitness centers; and international travel. Additionally, Kuwait is prohibiting celebrations for its National Day holiday on February 25. The duration of the measures varies by country, ranging from 10 days to several weeks.

MIXING VACCINES Researchers in the UK are initiating a clinical trial to evaluate the efficacy of vaccination using doses from 2 different vaccines. Allowing (or potentially recommending) individuals to receive 1 dose each from 2 different vaccines could introduce flexibility into vaccination programs and potentially even increase the degree of protection from the vaccination. The UK government has allocated approximately £7 million (US$9.6 million) to fund the study, and early data could be available by this summer. The study aims to include more than 800 participants aged 50 years and older who have not yet been vaccinated.

The trial will initially involve the Pfizer-BioNTech and AstraZeneca-Oxford University vaccines. The vaccines utilize different technology, with the Pfizer-BioNTech vaccine using an mRNA platform and the AstraZeneca-Oxford vaccine using an adenovirus platform. The participants will be divided among 8 trial arms. Four (4) will be control groups, which will receive 2 doses of the same vaccine (2 groups per vaccine) either 4 or 12 weeks apart. The other 4 groups will trial the mixed doses, with 2 groups receiving the AstraZeneca-Oxford dose first followed by the Pfizer-BioNTech dose, administered either 4 or 12 weeks apart, and 2 groups receiving the doses in the opposite order (4 or 12 weeks apart). The UK announcement stated that additional combinations could be added later, as additional vaccines received authorization.

US PHARMACY VACCINATIONS On February 2, the White House announced that the US government will increase distribution of SARS-CoV-2 vaccine doses nationwide. The principal increase will be in the form of 1 million doses per week that will be distributed to approximately 6,500 retail pharmacies nationwide, including major chains such as CVS, Rite Aid, and Walgreens. The pharmacies will make vaccination available to eligible individuals free of charge, which will dramatically increase the number of locations in the community where individuals can get vaccinated. The plan aims to scale up the number of participating pharmacies to 40,000 locations across the country.

Notably, the allocation for pharmacies will be in addition to the doses already distributed to states, and the state allotment will also increase by 500,000 doses per week, up to 10.5 million doses per week nationally. The initial pharmacy locations were deliberately selected to improve equitable access for “socially vulnerable communities” that are at elevated risk for infection and severe disease, including racial and ethnic minorities. Many pharmacies are already supporting vaccination operations in collaboration with state and local governments, but the new program will distribute the doses directly to pharmacies.

EMERGING VARIANTS & TESTING The emergence of new SARS-CoV-2 variants, particularly those that appear to be more transmissible and/or could mitigate the efficacy of vaccines or therapeutics, and expanded access to vaccination are raising concerns regarding the accuracy of existing tests. A team of researchers from the Johns Hopkins Center for Health Security developed an overview of diagnostic testing accuracy for these new variants as well as an insight into the potential effects of vaccination on diagnostic and serological testing.

The molecular diagnostic tests widely in use for SARS-CoV-2 detect infections by targeting specific genetic sequences present in the virus. In fact, a specific type of failure for these tests—an S-gene (spike protein) target failure—was instrumental in first detecting the B.1.1.7 variant. Both the B.1.1.7 and 501Y.V2 (B.1.351) variants have mutations on the spike protein; however, most existing test kits target other sets of genes. The majority of tests are expected to remain effective in detecting infection with the new variants, and the US FDA has issued a warning for those tests that utilize genetic sequences for the spike protein. Most of the existing diagnostic tests are capable of detecting infection with the known emerging variants; however, their sensitivity could be affected for future variants, depending on the specific mutations involved.

Vaccination is not expected to result in positive diagnostic tests. While both of the vaccines currently authorized for use in the US—the products from Pfizer-BioNTech and Moderna—both include mRNA corresponding to the spike protein, the quantity of mRNA in each dose is very small, much less than is generated during SARS-CoV-2 infection, and it does not amplify like the virus would. As we noted above, most diagnostic tests target other portions of the SARS-CoV-2 genome, and in combination with low quantity of mRNA, it is unlikely that an individual would test positive due to the vaccine. On the other hand, serological tests after vaccination could yield either positive or negative results, depending on the test. Serological tests identify the presence of antibodies as an indication of prior infection; however, the specific antibodies vary by test. The Pfizer/BioNTech and Moderna vaccines generate antibodies against the spike protein, so only serological tests that target those antibodies would yield positive results after vaccination. Conversely, tests that target antibodies against other parts of the virus (eg, receptor binding domain) would not identify the antibodies induced by the vaccine or provide any indication if the vaccine successfully generated an immune response.

2020 OLYMPICS The International Olympic Committee (IOC), International Paralympic Committee (IPC), and the Tokyo 2020 Organising Committee published the first in a series of “playbooks” that will outline protective measures that will be put in place during the 2020 Olympic and Paralympic Games* in Tokyo, Japan—currently scheduled for July-August 2021. Each playbook will focus on a specific stakeholder group, including the international federations, press, broadcasters, and athletes and officials. The playbook for athletes and officials has not yet been published; however, multiple media reports indicate that there will be testing requirements for athletes, both before arrival and regularly during their stay, and athletes will be directed to return home after they are done competing. Additionally, there could be a prohibition on physical contact between athletes outside of competition.
*The 2020 Olympic and Paralympic Games will retain their 2020 designation, even though they will be held in 2021.

https://covid19.who.int/

[JazzNU]

I have so, so much I could say about teachers these days. Or teacher's unions in particular. Not much of it positive, so I'll refrain from posting my true thoughts. But yeah, disappointed as I've almost always been in their corner.


Also, Dr. Wen being poached from MSNBC was real interesting.