Covid-19 Updates & Info

[ti-amie]

New Variant Detected in New York Amid Growing Crisis Over Vaccine Rollout
The sluggish pace of vaccinations has been particularly striking in New York City, the onetime epicenter of the pandemic.

By Jesse McKinley, Luis Ferré-Sadurní and Emma G. Fitzsimmons
Jan. 4, 2021
Updated 4:28 p.m. ET

ALBANY, N.Y. — New York, the onetime center of the pandemic, faced a growing crisis on Monday over the lagging pace of coronavirus vaccinations, as deaths continue to rise in the second wave and Gov. Andrew M. Cuomo came under mounting pressure to overhaul the process.

The concern over vaccinations came as the first case of a more contagious variant of the virus was confirmed in the state. The 60-year-old man who tested positive was recovering, but Mr. Cuomo was urging rapid testing for anyone who might have come into contact with him at the jewelry store in Saratoga Springs where he worked.
The discovery of the new variant was just the latest complication for state health officials, who are overseeing a planned inoculation of some 20 million state residents.

The small number of vaccine recipients is particularly striking in New York City, where roughly 110,000 people — in a city of more than eight million — have received the first of two doses necessary to help prevent serious cases of the disease. That is about a quarter of the total number received by the city.

Mayor Bill de Blasio called on the Cuomo administration to allow the city to inoculate a broad array of essential workers and New Yorkers who are 75 and older. The vaccinations had been limited to some health care workers and those living and working at nursing homes; on Monday, many more health care providers were made eligible for the vaccine.

“There’s lots more we can do if we have both those categories approved,” Mr. de Blasio said at a news conference on Monday.

Shortly after the mayor spoke, Mr. Cuomo rejected any notion that his administration was at fault, asserting that the problem was a local issue, and urging Mr. de Blasio and other local leaders who oversee public hospital systems to take “personal responsibility” for their performance.

“They have to move the vaccine,” the governor said in Albany. “And they have to move the vaccine faster.”

The governor threatened to fine hospitals up to $100,000 — and redirect future vaccines to other hospitals — if they did not rapidly increase the pace of vaccination. He also named the slower-performing hospital systems in a slide show, something he said he did not do “to embarrass” them but to make sure they are “held accountable.”

“We want those vaccines in people’s arms,” Mr. Cuomo said, adding, “This is a very serious public health issue.”

But efforts to speed up vaccinations may prove to be at odds with the strenuous task of making sure to prioritize the right people.

In one possible example, the state has advised clinics and other facilities to rank each employee using a matrix that takes into account age, comorbidities, occupation and the section of the facility where the person works.

Mr. Cuomo said he would propose legislation that would impose criminal charges for facilities or health care providers that did not follow guidelines on who is eligible for the vaccine. “This vaccine can be like gold to some people,” the governor said.

Asked about whether his threat of fines for hospitals — already warned that they will face penalties if they break state mandates on who gets the vaccine — could be slowing down the process, Mr. Cuomo said no.

“I want to get needles in the arms and I want to get that done quickly as possible,” he said. “If there are some hospitals that are better at doing that, then they should be doing that.”

The governor estimated that about 300,000 people had received the vaccine in New York, but offered no single reason for the slow pace of vaccination. “There is no one cause,” he said, noting that he had spoken to dozens of hospitals about the issue.

He did suggest, however, that “management capacity and efficiency” were causing problems, saying there was a lack of “urgency” at some hospitals.

“It’s bureaucracy,” he said.

Mr. de Blasio acknowledged that the city’s rollout had been slow, blaming the logistical challenges of dealing with a new vaccine, and said the city took a cautious approach as it laid the groundwork for more widespread distribution.

“Now it’s time to sprint,” Mr. de Blasio said.

Avery Cohen, a spokeswoman for the mayor, said that Mr. de Blasio has stressed to the city’s public hospital system — NYC Health and Hospitals — that they should “get as many vaccines in arms as possible.” But she questioned the logic of Mr. Cuomo’s pledge to cut off hospitals that are not fast enough for his taste.

“Threatening to revoke the privilege of vaccination from the city’s public hospital system is punitive and unnecessary,” Ms. Cohen said.

Other elected officials in the city have been urging a more aggressive plan of attack, with round-the-clock operations. On Monday, the mayor seemed to agree, promising three new “vaccination hubs” would open on Sunday in Brooklyn, Queens and the Bronx, and pledging to offer shots of the vaccine seven days a week and 24 hours a day when possible. The city also hoped to double the number of locations offering vaccination to 250 sites by the end of the month.

The mayor repeated his pledge to reach a rate of 400,000 doses per week by the end of the month, with a goal of one million doses — safeguarding at least a half-million residents — by February.

Mr. de Blasio and Mr. Cuomo have long had a difficult relationship, but they have tried to show a united front in recent weeks as the state and city face a second wave of the virus. Mr. de Blasio was careful on Monday not to directly criticize Mr. Cuomo, but called on “the state” several times to alter its approach.

The mayor showed no such restraint when it came to the federal government, suggesting in a slide show that the “feds” needed to “PICK UP THE PACE” on distributing the vaccine.

Mr. Cuomo, a third-term Democrat, has touted his own response to the coronavirus crisis and the state’s vaccination plan in recent months, though statistics continue to bear troubling news: On Monday, more than 8,200 residents in the state were hospitalized with the coronavirus, levels not seen since early May, as deaths have topped 100 a day for several weeks. On Monday, the governor reported 170 deaths, the highest daily count since the dark days of the spring.

Over the past week, the state has seen more than 10,000 new cases per day, as the statewide rate of positive test results has also jumped alarmingly, even before an expected increase tied to holiday travel and gatherings. New York continues to be the hardest hit state in the nation, with more than 38,000 deaths.

Mr. Cuomo said on Monday that “there have been issues with the delivery of the vaccine,” laying that blame with federal officials whom he has regularly criticized for their handling of the crisis.

He said that the state would expedite delivery and injection of the vaccine to nursing homes — where thousands of New Yorkers have died — aiming to get 85 percent of residents vaccinated by the end of this week.

“The federal program has not worked as quickly as we would have liked,” Mr. Cuomo said.

Jesse McKinley is the Albany bureau chief. He was previously the San Francisco bureau chief, and a theater columnist and Broadway reporter for the Culture Desk. @jessemckinley

Luis Ferré-Sadurní covers New York State politics in Albany. He joined The Times in 2017 and previously wrote about housing for the Metro desk. He is originally from San Juan, Puerto Rico. @luisferre

Emma G. Fitzsimmons is the City Hall bureau chief, covering politics in New York City. She previously covered the transit beat and breaking news. @emmagf

https://www.nytimes.com/2021/01/04/nyre ... llout.html

[ti-amie]

To be fair no one gets along with Andrew and Bill isn't a walk in the park either so thatconversation, while often repeated, should be put aside.

[ponchi101]

This happens so often, or at least in my industry. You set up so many regulations that eventually the system does not move.
If you are:
Over 60, or
Work at a hospital, or
Have some underlying condition

You get the vaccine. Make it simple.

[ti-amie]

Third national lockdown announced in England amid coronavirus surge driven by variant strain

By
Karla Adam,
Jennifer Hassan and
Ben Guarino
Jan. 4, 2021 at 6:06 p.m. EST

LONDON — Prime Minister Boris Johnson on Monday ordered a third national lockdown for England amid a surging coronavirus outbreak driven by a U.K. variant that appears to be more contagious and may have greater implications for children.

In a televised address to the nation on Monday evening, Johnson said the new variant was 50 percent to 70 percent more transmissible, spreading at a rate he called “frustrating and alarming.”

“With most of the country already under extreme measures, it’s clear that we need to do more together to bring this new variant under control while our vaccines are rolled out,” he said. “In England, we must, therefore, go into a national lockdown which is tough enough to contain this variant.”

Speaking on a visit to a hospital in London earlier in the day, Johnson said, “We have a new variant that is requiring extra-special vigilance.” The variant has spread to more than 30 countries.

The Monday announcement comes after a national lockdown in March and then a four-week one that began in November.

The government had been facing growing calls to impose further restrictions as coronavirus cases continue to rocket. On Monday, Britain recorded 58,784 new daily cases, the highest figure recorded here during the pandemic.

“Let me be candid with you: This virus is out of control,” London Mayor Sadiq Khan told LBC Radio earlier Monday. “We have more patients in hospital in London now with covid than anytime in March, April and May during the peak. Plus, we have the additional non-covid winter pressures.”

Britain has recorded more than 50,000 daily cases for seven days. The number of patients in London hospitals has more than doubled over the past two weeks. At least one London hospital has had to postpone urgent cancer surgeries this week because it is overwhelmed with covid patients.

Under the new lockdown, everyone in England will be asked to stay at home except in special circumstances. Schools and universities will close for in-class learning with immediate effect.

In his televised address, Johnson said, “I want to stress that the problem is not that schools are unsafe for children — children are still very unlikely to be severely affected by even the new variant of covid.

“The problem is that schools may nonetheless act as vectors for transmission, causing the virus to spread between households.”

The more contagious variant, which has spread to dozens of countries and has been detected in four U.S. states, may have had a disproportionate effect on people under 20 in the United Kingdom, according to a new report that has not gone through scientific peer-review.

When the study authors evaluated patients by age, they found a slightly higher proportion of new variant vs. non-variant cases in people younger than 20. The researchers’ observations cannot explain why. The difference they detected may have been circumstantial.

The fresh lockdown comes as Britain began rolling out the Oxford-AstraZeneca vaccine. Early Monday morning, Brian Pinker, 82, became the first person in the world to get a shot of the vaccine outside of clinical trials. The former maintenance manager rolled up his sleeve at a hospital in Oxford, where the vaccine was developed. “The vaccine means everything to me. To my mind, it’s the only way of getting back to normal life,” Pinker said afterward.

The government hopes that the Oxford-AstraZeneca vaccine, which is cheaper to produce and easier to transport than other vaccines that are being administered, will be a “game changer.” Nursing home residents, health-care workers and those over 80 are at the front of the line. Britain recently shifted its vaccine strategy so that it could inject as many people as possible, as quickly as possible, by allowing for 12 weeks between the first and second dose instead of the usual 21 days.

But inoculating an entire nation will take months, and the growing number of cases and hospitalizations has sparked alarm in Britain.

Scotland’s semiautonomous government also announced a new lockdown Monday for at least the rest of the month. Nicola Sturgeon, the first minister of Scotland, told the Scottish Parliament that starting Tuesday, there would be “a legal requirement to stay at home except for essential purposes. This is similar to the lockdown of March last year.”

She also said that students would move to remote learning for the rest of the month.

Sturgeon said that the “overall level of community transmission is simply too high” to keep schools open and that there was still “significant uncertainty about the impact of the new variant on transmission amongst young people.”

In England, schools will move to remote learning from Tuesday.

More than three-quarters of England was already at “Tier 4,” the highest level of restrictions.

Health Secretary Matt Hancock told the television program “Good Morning Britain” on Monday that Britain’s temporary “Nightingale hospitals,” built in weeks last year, were on “standby if needed.”

The National Health Service said in a statement that it was “working hard” to ready London’s flagship Nightingale hospital to treat patients “if necessary.” The London center will be used to rehabilitate people who are recovering from an emergency stay in a hospital and will not be used to treat patients who have covid-19, the statement said.

British media outlets have reported in recent days that the majority of the seven Nightingale hospitals had been dismantled or were not being used as cases began to climb in the country again — prompting many to question why.

ICU nurse Dave Carr told “Good Morning Britain” on Monday that the rise in infections was “breaking” exhausted NHS staff working in intensive care units in London that are full with patients, who are forced to share ventilators.

“The admissions keep coming in,” Carr said, adding that all available staff are already working at NHS hospitals and finding staff for the Nightingale facilities would be difficult. “It’s absolutely appalling planning,” he said of the government’s handling of the crisis.

Former health secretary Jeremy Hunt was among those on Monday urging the government to “close schools, borders, and ban all household mixing RIGHT AWAY.”

“To those arguing winter is always like this in the NHS: you are wrong,” he tweeted. “I faced four serious winter crises as Health Sec and the situation now is off-the-scale worse than any of those.”

Guarino reported from New York.

https://www.washingtonpost.com/world/br ... story.html

[ti-amie]

Pharmacist Accused of Tampering With Vaccine Was Conspiracy Theorist, Police Say
The police say a Wisconsin pharmacist believed the Moderna vaccine would harm people and tried to sabotage the effort to vaccinate frontline workers.

By Shaila Dewan and Kay Nolan
Jan. 4, 2021
Updated 6:33 p.m. ET


Police said Steven Brandenburg had twice removed a box of vials of the Moderna vaccine from the refrigerator for periods of 12 hours, rendering them “useless.”
Credit...Ozaukee County Sheriff's Office, via Associated Press

A pharmacist who was arrested on charges that he intentionally sabotaged more than 500 doses of the Covid-19 vaccine at a Wisconsin hospital was “an admitted conspiracy theorist” who believed the vaccine could harm people and “change their DNA,” according to the police in Grafton, Wis., where the man was employed.

The police said Steven Brandenburg, 46, who worked the night shift at the Aurora Medical Center in Grafton, Wis., had twice removed a box of vials of the Moderna vaccine from the refrigerator for periods of 12 hours, rendering them “useless.”

“Brandenburg admitted to doing this intentionally, knowing that it would diminish the effects of the vaccine,” the police said.

The attempt to destroy precious doses of the vaccine came over the holidays as the state worked to administer vaccines quickly to frontline health care workers. As of Saturday, the state had received 159,800 doses of vaccines and had administered 64,657, according to the Centers for Disease Control and Prevention. Although the Moderna product is sometimes described as a “genetic” vaccine, it does not alter a person’s genes in any way.

The vials, which contained 570 doses of vaccine and which prosecutors said were worth between $8,000 and $12,000, were discovered sitting out on Dec. 26. Five days later, Mr. Brandenburg was arrested on felony charges of reckless endangerment and property damage, though prosecutors on Monday said the charges could be dropped to a single misdemeanor if the vials, which have yet to be tested, are still usable.

The prosecutor, Adam Gerol, said that Mr. Brandenburg was “pretty cooperative and admitted to everything he’d done,” and that “he expressed that he was under great stress because of marital problems.” He said that according to co-workers, Mr. Brandenburg had brought a gun to work on two prior occasions.

Last month Mr. Brandenburg told his wife, who is in the process of divorcing him, that “the world is crashing down around us,” according to a motion she filed last week asking for sole custody of the couple’s two daughters, 4 and 6, after she learned he was under investigation in the incident at the hospital. She said she feared his reaction if he lost his job.

In her motion, Gretchen Brandenburg said that on Dec. 6, her husband picked up the children and dropped off a water purifier, a large bucket of powdered milk and two 30-day emergency buckets of food.

“He told me that if I didn’t understand by now that he is right and that the world is crashing down around us, I am in serious denial,” she said in an affidavit. “He continued to say that the government is planning cyberattacks and plans to shut down the power grid.”

She asked that his time with their children be supervised, saying he had made alarming remarks. The six-year-old had quoted him as saying, “This is not our home; heaven is our home,” and “All the bad angels and the devil are going to burn in the lake of fire forever,” she wrote.

“I was so concerned about my safety and the safety of our children that I left town for a period of time,” she wrote.

The Brandenburgs married in 2012, and Ms. Brandenburg filed for divorce last June. At a hearing in July, her lawyer testified that his client feared Mr. Brandenburg’s “temper” and said the parties have “vastly different views regarding parenting and views of the world.”

“My understanding is that the respondent is more aligned with the feeling of conspiracy theories,” the lawyer, Brian Herro, said. “He has theories about Covid-19. He believes the end of the world is coming. So my client would like him to be out.”

Mr. Brandenburg’s criminal defense lawyer, Jason Baltz, declined to comment. Mr. Herro did not immediately respond to a request for comment.

In an order signed Monday, the family court granted temporary sole custody to Ms. Brandenburg, finding that the children were in “imminent danger of physical or emotional harm.”

But the criminal court granted Mr. Brandenburg release on a promise to pay $10,000 if he did not show up for his next hearing, on Jan. 19. He was ordered to surrender any firearms; the prosecutor said the police had already confiscated some of his guns.

The Moderna vaccine must be kept frozen or refrigerated until it is used, though it does not require subarctic temperatures like the Pfizer vaccine does. The hospital has said that 57 people received injections of the compromised vaccine, but that Moderna had reassured officials that they would not harm the individuals who received them.

Hospital officials at first believed that the vials were left out inadvertently, but upon further investigation determined that the act had been intentional. They said the pharmacist was no longer employed.

In a July divorce hearing dealing with multiple issues, including whether Mr. Brandenburg should be required to move out of the family home, he talked about the pressure of his job, working from 9 p.m. to 7 a.m. “It’s not easy, especially with all of the other stress going on, in order to get enough sleep to function for work,” he said. “And if I make mistakes at work — I’m a hospital pharmacist at Grafton, right? — I’m responsible for life and death issues.”

The incident raised new fears of inadequate security for the vaccine. Last Thursday, in a video call with reporters, Jeff Bahr, the president of Aurora Health Care Medical Group, defended the hospital system’s protocols. “It’s become clear that this was a situation involving a bad actor, as opposed to a bad process,” he said.

The scarcity of supply has led some officials to store the vials at undisclosed locations, install security cameras and tracking systems or restrict access. Early in December, Interpol warned nations to prepare for attempts by organized crime rings to target vaccine supply chains. But most of the attention has focused on attempts to steal or divert the vaccine, not tamper with it.

Wisconsin experienced a surge of coronavirus cases in the fall, and at times has been one of the hardest-hit states in the nation relative to its population. Transmission has since slowed a bit, but the state is still reporting about 43 new cases a day for every 100,000 people. At least 5,264 Wisconsin residents have died.

Shaila Dewan is a national reporter and editor covering criminal justice issues including prosecution, policing and incarceration. @shailadewan

https://www.nytimes.com/2021/01/04/us/p ... e-say.html

[Deuce]

The problem isn't so much the virus... the main problem, by far, is human beings.

Not just 'extremists' like the conspiracy theory pharmacist and those of his ilk, but also the people who somehow think that they can get away with not wearing masks or not being physically distant from others. We all know by now what to do and what to not do to greatly minimize the chances of contracting the virus. We've been hearing it for 9 months straight, over and over. But the lack of accurate foresight - and/or lack of concern for others - is incredible. These people - and there are millions of them, unfortunately - feel that, because the statistics show that they'll probably survive the virus, don't take proper precautions. They either don't think about or simply don't care about the fact that if they contract the virus, even if they are minimally affected by it themselves, they can pass it on to others who could die from it.

Yeah - the problem is definitely the human animal.

[ponchi101]

Sure, but in this particular case, the problem with the human animal in this news is that this is more animal than human.
I wrote about it. This thing has defeated us. But, if on top of that, we have this kind of people sabotaging what is the only way to get rid of this virus, we can reach newer levels of despair. Which is outstanding after the four years we (America) has been through.

[ponchi101]

Local update:
cars going doing the street with a PSA reminding people that the borough is under quarantine.
And therefore, (expletive) your rights. This is bigger than that.
(Which I agree).

[ponchi101]

And the USA has reached this stage.
Ambulance crews told not to transport patients who have little chance of survival
https://www.yahoo.com/news/l-hospitals- ... 12269.html

Off-hospital triage.

[Suliso]

It's very hard to find any sustainable solution on this, but clearly assholes like the one above are not improving odds.

[ti-amie]

Kurt "Masks Save Lives" Eichenwald @kurteichenwald

Doctor in Illinois: A alarming number of teenagers are turning up at the hospital with brain swelling and heart damage during/post COVID infection. Also a huge spike in people showing up with new autoimmune diseases including type 1 diabetes likely incident to pancreatic damage.

[dryrunguy]

I apologize for being remiss in posting these of late. Here's the Situation Report for January 4, 2021.

::

EPI UPDATE The WHO COVID-19 Dashboard reports 84.23 million cases and 1.84 million deaths as of 4:00am EST on January 5. Over the past 2 weeks, the WHO reported decreased global weekly incidence and mortality compared to the week of December 14, potentially a result of reporting delays over the 2 holiday weekends. The global cumulative incidence surpassed 80 million cases on December 29. From the first reported COVID-19 case, it took 177 days to reach 10 million cases. From there:
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
70 to 80 million- 16 days

The global cumulative mortality surpassed 1.75 million deaths on December 27. From the first reported death, it took 115 days to reach 250,000 deaths. From there:
250k to 500k- 56 days
500k to 750k- 46 days
750k to 1 million- 45 days
1 to 1.25 million- 40 days
1.25 to 1.5 million- 26 days
1.5 to 1.75 million- 23 days

On December 26, the US surpassed 330,000 cumulative COVID-19 deaths, which equates to approximately 1 death for every 1,000 people nationwide. The US is not the first country to reach this milestone, but it is certainly the largest in terms of population. To date, only 18 countries have reported per capita cumulative mortality greater than 1 death per 1,000 population. All but 2 of these countries are located in Europe, with the exceptions being Peru (1.15) and the US (1.07). More than half of these countries have populations less than 10 million, including 4 with fewer than 1 million people. San Marino—with a population of fewer than 34,000—is #1 globally, with 1.83 deaths per 1,000 population. Notably, Belgium (population 11.6 million) is close behind at 1.70. Slovenia is #3 with 1.37 deaths per million.

The trends in cumulative incidence among the European countries are very similar over the course of the pandemic, whereas Peru and the US exhibit different trajectories. In Europe, countries that were severely affected early in the pandemic have steep initial curves, which began to level off in May. The cumulative mortality curves for most of the European countries, regardless of whether they were severely affected during Europe’s “first wave,” were relatively flat over the summer before sharp increases starting in September-October, corresponding to Europe’s second wave. In contrast, Peru’s cumulative mortality curve increased steadily through approximately August, at the height of South America’s first wave, and has tapered off since that time. The United States’ initial sharp increase in March-April, during the initial COVID-19 surge, was less pronounced than many European countries; however, when Europe brought its COVID-19 epidemic over the summer under control, COVID-19 mortality in the US continued to grow steadily during its summer resurgence. US mortality rate then increased again in November, corresponding to the autumn/winter surge.

UNITED STATES
The US CDC reported 20.56 million total cases and 350,664 deaths. The US reported a new single-day record incidence of 284,554 new cases on January 3, becoming the first country to report more than 250,000 new cases in a single day. The US surpassed 20 million cumulative cases on January 2. From the first case reported in the US, it took 200 days to reach 5 million cases. From there:
5 million to 10 million- 92 days
10 million to 15 million- 29 days
15 million to 20 million- 24 days

The US surpassed 325,000 cumulative deaths on December 23 and 350,000 deaths on January 4. The 9 days to increase from 300,000 to 325,000 deaths matched the rate at the peak of the initial surge in March. Notably, the 12 days between 325,000 and 350,000 included 2 major holiday weekends, which likely delayed reporting to some extent. From the first US death, it took 55 days to reach 50,000 deaths. From there:
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

As a reminder, it may be difficult to track national-level epidemiological trends in the US over the coming weeks. Reporting delays over the Christmas and New Year’s holiday weekends, and associated catch-up reporting, could obscure epidemiological trends, including the effects of holiday travel and gatherings as far back as Thanksgiving.

While many of the metrics we track vary considerably over holiday weekends, hospitalizations tend to remain relatively consistent. Analysis reported by the COVID Tracking Project shows a 4.6% increase in hospitalizations for the last week of 2020, compared to the previous week. The number of nationwide hospitalizations does appear to be tapering off to some degree, but the US continues to set new records, now more than double the number of hospitalized COVID-19 patients reported at the height of the previous 2 peaks. Hospitalization trends vary by region, as the US epidemic shifts away from the Midwest, which was most severely affected in the earlier part of the autumn/winter surge. States in the South and West regions continue to report increasing hospitalizations, including new records in the South. Hospitalizations in the Midwest peaked in late November/early December and are now steadily decreasing, and Northeastern states appear to be approaching a second peak. While the raw totals vary widely by region, the per capita hospitalizations are actually relatively even, with all 4 regions falling between 310 and 410 hospitalizations per million population. In total, 6 states are reporting more than 500 hospitalizations per million population: Alabama (628), Arizona (659), California (560), Georgia (530), Nevada (632), and Tennessee (508). Only 2 states, Hawai’i (60) and Vermont (66), and Guam (68) are reporting fewer than 100 hospitalizations per million.

The Johns Hopkins CSSE dashboard reported 20.84 million US cases and 354,263 deaths as of 11:30am EST on January 5.

VACCINE AUTHORIZATIONS Considerable progress has been made over the past several weeks in terms of regulatory agencies authorizing the use of SARS-CoV-2 vaccines, including several new vaccines that had not previously been authorized for use anywhere. Following the US emergency authorization of the Moderna vaccine, Health Canada authorized the Moderna vaccine for use among the public. Canada is the second country to authorize the Moderna vaccine, and this is the second vaccine authorized for use in Canada. Additionally, the WHO issued its first Emergency Use Listing (EUL) for a SARS-CoV-2 vaccine for the Pfizer/BioNTech version. An EUL from the WHO can help expedite regulatory review and authorization in countries around the world, and it “enables UNICEF and the Pan-American Health Organization [PAHO] to procure the vaccine for distribution to countries in need.”

On December 30, the UK became the first country to issue an emergency authorization for the AstraZeneca/Oxford University vaccine, which was developed in the UK. This is the second vaccine authorized for use in the UK. India also authorized the use of the AstraZeneca/Oxford vaccine, which it is manufacturing domestically.

Additionally, India issued an emergency authorization for the vaccine developed by Bharat Biotech, an Indian pharmaceutical company, that appears to still be in the middle of Phase 3 clinical trials. Reportedly, the absence of publicly available Phase 3 trial data for the AstraZeneca/Oxford and Bharat Biotech vaccines and a lack of transparency regarding the conduct of those trials has prompted criticism from health experts in India, following the authorization of the two vaccines.

The European Medicines Agency (EMA) is reportedly assessing the Moderna vaccine for emergency use, but it has not yet finalized its recommendation. Additionally, an EMA official indicated that it could be another month or longer before it can evaluate and authorize the AstraZeneca/Oxford vaccine. A rolling review of the interim Phase 3 clinical trial data is underway, but AstraZeneca still needs to submit its request and provide additional data.

China issued a conditional approval for the vaccine developed by Sinopharm, a state-operated pharmaceutical company. China is not the first country to approve the vaccine, but this appears to be the first official authorization issued by the Chinese government. Egypt also reportedly authorized the use of the Sinopharm vaccine, and vaccination efforts are expected to begin later this month. Millions of doses of China’s Sinovac vaccine recently arrived in Indonesia; however, formal emergency authorization is still needed before vaccination efforts can begin. Unlike the Pfizer/BioNTech and Moderna vaccines, the final Phase 3 clinical trial data have not yet been published publicly for the AstraZeneca/Oxford, Bharat Biotech, and Sinopharm vaccines, and it appears that the Bharat Biotech vaccine is still undergoing Phase 3 trials.

US VACCINATION The rollout of the United States’ SARS-CoV-2 vaccination program has faced a number of challenges. While the federal government is responsible for procuring and distributing the vaccine, public health and healthcare in the US are largely controlled at the state level. According to US CDC data, more than 15 million total doses have been distributed nationwide; however, only 4.5 million (29.5%) have been reported as administered. This total includes 2.5 million doses distributed for use at long-term care facilities (LTCFs), of which only 365,000 (14.4%) have been administered. While distribution to states is relatively balanced nationwide, on a per capita basis, the speed at which states are administering the vaccines varies widely.

Delays in administering vaccines in several states have received significant media coverage. In Florida, for example, images and videos show older adults, many in wheelchairs, waiting in long lines to receive their vaccines, including some who waited outside overnight for the opportunity to be vaccinated. In Florida, local governments are responsible for implementing mass vaccination programs, including mechanisms to schedule appointments and allocate doses to appropriate populations, and differences in their approaches have impacted mass vaccination operations. States also vary in terms of who is eligible for vaccination, including who gets priority among the highest tier groups. In some states, such as New York, healthcare workers in primary care or outpatient settings were not among the initial priority for eligibility, but eligibility was expanded this week to include them. Many health professionals and experts have noted challenges that primary care clinicians are facing in terms of getting vaccinated, particularly considering their risk of exposure to patients with milder symptoms or who are seeking testing. Other states, such as Louisiana, are expanding beyond the federal Tier 1a recommendations to include all adults aged 70 years and older.

In some states, delays in administering the allocated vaccine doses have prompted stern responses from state officials. In Florida, Governor Ron DeSantis threatened to withhold future allotments from hospitals that do not increase the pace of their vaccinations. Similarly, New York Governor Andrew Cuomo indicated that he would hold back future doses and potentially impose substantial fines for hospitals that do not administer their allocated doses by the end of this week. One of the challenges affecting hospitals’ ability to administer their vaccines is opacity in the national allocation and delivery process. States may not know how many doses they will receive until days before the delivery arrives, so governments and hospitals may be unwilling to administer their entire inventory to ensure they have enough on hand to cover the second doses. Until state and local governments and health systems can gain confidence in the delivery volume and timeline, we could continue to observe lower vaccination rates in many locations.

EU VACCINATION European countries began initiating their mass vaccination efforts against SARS-CoV-2 on December 26. As of now, only the Pfizer/BioNTech vaccine is authorized for use in Europe; however, other vaccines are currently under evaluation by the European Medicines Agency (EMA), including ongoing assessments regarding emergency authorization for the Moderna vaccine, which has already been issued an Emergency Use Authorization (EUA) by the US FDA. As of today, EU countries have administered more than 900,000 doses of the vaccine, led by Germany, which has administered the first dose to nearly 317,000 individuals.

ISRAEL VACCINATION Israel appears to be leading all other countries in terms of its mass vaccination program. Since commencing vaccination operations on December 19, Israel has administered more than 1 million doses nationwide, covering more than 10% of its population. For comparison, the US has administered 4.56 million doses; however, on a per capita basis, Israel (14.14 doses per hundred population) is exceeding #2 Bahrain (3.62) by a factor of 4 and the UK (#3; 1.39) and US (#4; 1.38) by a factor of 10. Reportedly, Israel is administering more than 150,000 vaccinations per day. While this pace could enable Israel to cover 100% of its population (9 million) within 2 months, progress on administering the first doses will largely pause from January 10-31 to begin administering second doses. Israel is currently only using the Pfizer vaccine, but it expects to receive its first doses of the Moderna vaccine in March.

UK VACCINATION TIMING In an effort to increase the number of people with some degree of protection against SARS-CoV-2, the UK government announced that it is increasing the time between the first and second dose of SARS-CoV-2 vaccines to 4 months, for both the Pfizer/BioNTech and AstraZeneca vaccines. The policy will be implemented across all 4 UK countries based on advice from the UK’s Joint Committee on Vaccination and Immunisation (JCVI). This decision increases the time before individuals can be fully vaccinated against SARS-CoV-2; however, it allows the UK government to use its available vaccine doses to provide the first dose to more people, which can provide them with a lower degree of protection.

Some health experts, including multiple professional associations in the UK, have expressed opposition and concern about the decision, noting that the vaccines were not necessarily designed to be administered in this manner, and the clinical trials did not explicitly evaluate the degree or duration of protection conferred through partial vaccination. The concerns include a lower degree of protection from a single dose, waning immunity after 21 days, and the potential that partial immunity could contribute to the emergence of vaccine-resistant strains of the virus. The UK’s Chief Medical Officers defended the policy by citing the need to provide protection to as many people as possible, even if it is not the full degree of protection offered by the full vaccination. They argue that the first dose accounts for “the majority of the initial protection” and that the second dose contributes more to the duration of immunity. Notably, Pfizer issued a statement indicating that its clinical trials did not provide data on the level of protection conferred by the first dose beyond 21 days. The US FDA issued a statement yesterday indicating that the US would not follow the UK’s lead and would, instead, continue to administer the second vaccine doses at the “specified intervals,” 3 weeks for the Pfizer/BioNTech vaccine and 4 weeks for the Moderna vaccine.

VACCINE PHASE 3 CLINICAL TRIALS While a small selection of vaccines have gone through clinical trials and are conditionally approved for use, other vaccines are still under investigation and going through the clinical trials process. The vaccine candidate developed by Novavax recently entered Phase 3 clinical trials. The participants will be grouped into 2 cohorts, one aged 18-64 years and the other for individuals aged 65 years and older. The older cohort will form at least 25% of the intended 30,000 trial participants in the US and Mexico. The trial also aims for diversity among the participants, emphasizing the recruitment of racial and ethnic minorities that have been more severely affected by the pandemic, including Black, Latino/x, and Native American communities. The Novavax vaccine is a protein subunit vaccine and requires 2 doses administered 21 days apart.

The Kazakh Research Institute for Biological Safety Problems (RIBSP) also recently initiated Phase 3 clinical trials for its candidate vaccine, an inactivated vaccine that is also delivered in 2 doses administered 21 days apart. The Phase 3 trials will begin with 3,000 participants, but RIBSP is already scaling up production of the vaccine. According to information published by the US National Institutes of Health, the Phase 3 trials are expected to include only 3,000 participants (2,400 in the treatment arm), which is much smaller than the Phase 3 trials for other SARS-CoV-2 vaccine candidates. Additionally, a dedicated production facility is expected to be commissioned in March, which will reportedly be capable of manufacturing 60 million doses per year. Vaccinations could begin as early as March, but like other vaccines, this is contingent on demonstrating safety and efficacy in larger Phase 3 trials and obtaining the necessary regulatory authorization. Additionally, the candidate developed by India’s Zydus Cadila initiated Phase 3 clinical trials, which are expected to include 30,000 participants.

The results of the Phase 3 clinical trials for the Moderna vaccine were recently published in the New England Journal of Medicine. These data have already been published publicly, but they have now completed the peer review process. The Beijing Biological Products Institute has also announced preliminary Phase 3 clinical trial results for the Sinopharm candidate vaccine. According to the press release, the Sinopharm vaccine generated neutralizing antibody response in 99.52% of vaccines and demonstrated 79.34% efficacy. This is slightly lower than the 86% efficacy reported for the vaccine in an earlier trial in the United Arab Emirates, and no additional data were included in the statement.

OTHER VACCINATION NEWS Some early vaccine recipients reported allergic reactions after receiving the vaccine, but these types of reactions are not unique to the new SARS-CoV-2 vaccines. Four (4) vaccine recipients in Germany were reportedly admitted to the hospital after accidentally receiving 5 times the recommended dose for the Pfizer/BioNTech vaccine. The increased dose was accidentally administered to 8 individuals, and 4 were hospitalized for monitoring after experiencing flu-like symptoms. A pharmacist in Milwaukee, Wisconsin (US), was arrested for purposefully storing more than 500 vaccine doses unrefrigerated, which rendered them unusable. In West Virginia (US), 42 prospective vaccine recipients were mistakenly given an injection of the Regeneron antibody treatment instead of the SARS-CoV-2 vaccine. All of the affected individuals are expected to recover with no harmful effects. In New York, a major healthcare network is under investigation after violating the state’s directives by administering vaccinations to members of the general public rather than frontline healthcare workers and long-term care facility (LTCF) residents. The state fined the health system US$1 million for the violation.

NATIONAL SOCIAL DISTANCING & LOCKDOWN As countries around the world begin to implement SARS-CoV-2 vaccination programs or look ahead to future vaccination efforts, some are recognizing the need to strengthen social distancing and other COVID-19 containment measures in response to ongoing surges in transmission. Germany, which leads the EU in terms of vaccine doses administered, is reportedly considering an extension to its national “lockdown,” which is currently scheduled to end January 10. Germany is averaging nearly 18,000 new cases per day, which corresponds to more than 200 daily cases per million population. The UK is entering another period of “lockdown” as well, following the emergence of the B.1.1.7 variant and associated increases in incidence. New national Level 4 lockdowns are now in place in England, Scotland, and Wales, and Northern Ireland increased its national restrictions on December 26. South Africa also strengthened COVID-19 restrictions nationwide to Level 3 on December 29, which orders the closure of beaches and parks in hotspot areas, the closure of bars and pubs nationwide, and prohibits all alcohol sales, among other restrictions.

US ECONOMIC STIMULUS US President Donald Trump signed a US$900 billion COVID-19 economic stimulus package on December 27. He initially rejected the package and insisted that the Congress increase the individual payments from US$600 to US$2,000; however, after the House of Representatives passed a bill to increase the payments, the Senate did not vote on the bill. President Trump subsequently signed the original bill, but the delay caused a disruption in unemployment funding to millions of Americans that rely on this aid following the severe economic consequences of COVID-19.

Under the current bill, Americans enrolled in federal unemployment programs will receive a weekly US$300 unemployment supplement through mid-March. The stimulus package also includes funding for industries that have been severely affected by COVID-19. Additionally, US$82 billion will be allocated for educational resources, including both K-12 and colleges and universities. The package also includes US$285 billion in support for small businesses, including through the Paycheck Protection Program (PPP). Notably, the PPP will have stricter conditions for enrollment than previous stimulus packages, limiting eligibility to businesses with fewer than 300 employees that experienced at least a 25 percent drop in sales. Of that US$285 billion, US$12 billion is specifically set aside for minority-owned businesses. The airline industry will receive US$45 billion to continue to pay employees at a time when the travel and tourism industries continue to experience severe interruptions. Many billions are also set aside to support contact tracing, diagnostic testing, and vaccine distribution efforts.

SARS-CoV-2 VARIANTS Viral mutation is a common, expected process, although genetic changes often do not result in improvements or fitness advantages for the virus. The SARS-CoV-2 variants first identified in the UK and South Africa, however, do appear to have advantageous mutations in the spike protein, which allow the virus to more efficiently enter cells to begin the viral replication process. Emerging evidence indicates that these changes at the cellular and molecular level may result in increased transmissibility for these variants. Furthermore, these variants are emerging as the dominant strains of SARS-CoV-2 in the UK and South Africa, respectively. In response to news of the emerging variants, many countries have implemented travel restrictions for the UK, but the variant has already been identified in at least 37 countries, including the US.

Increased transmissibility of the SARS-CoV-2 variants poses serious problems to pandemic control efforts, especially among already burdened healthcare facilities. Preliminary studies indicate that the SARS-CoV-2 variants do not cause increased disease severity or case fatality; however, an increase in case loads substantially, further straining hospital systems. Social distancing measures—including mask use, physical distancing, and enhanced hygiene practices—will be critical to limit the spread of these new variants. Some scientists and health authorities have expressed concern over the possibility that existing vaccines and vaccine candidates may be less effective against the new variants, but preliminary studies have not found any indication current vaccines will be less effective in protecting against the UK variant. There are fewer studies on effectiveness against the South Africa variant, but research is ongoing. Notably, if current vaccines are determined to be less effective, BioNTech scientists have stated that they could make necessary changes in approximately 6 weeks.

https://covid19.who.int/

[shtexas]

I think I managed to get my Mom a vaccine appointment. Saturday at the grocery pharmacy about 25 minutes north of me. Hope it happens. It has been quite an adventure trying to get one.

[ponchi101]

Good for you, and specially for her. Keep us posted on how it goes, as I am, by now, ready to break into a lab, steal the frigging thing, and inject myself.

[shtexas]

Good for you, and specially for her. Keep us posted on how it goes, as I am, by now, ready to break into a lab, steal the frigging thing, and inject myself.

Once I am sure my Mom has had hers, I will go through it again for me. My pharmacist says I am eligible to take it now because of my high blood pressure. Plus, I think they are going to be in this eligibility group for a long time. Dallas County has been behind the curve. Not too surprising.