Britain approves vaccine and will begin shots within days – The Philadelphia Inquirer

Britain approves vaccine and will begin shots within days – The Philadelphia Inquirer

Arwady, Pritzker Don’t Anticipate COVID-19 Vaccine Will be Mandated by Officials – NBC Chicago

Arwady, Pritzker Don’t Anticipate COVID-19 Vaccine Will be Mandated by Officials – NBC Chicago

December 2, 2020

As the state of Illinois and the city of Chicago prepare to receive the first doses of approved coronavirus vaccines in the coming days and weeks, public health officials say there are still no plans in place to mandate that residents receive the treatment.

Dr. Allison Arwady, director of the Chicago Department of Public Health, says that she does not anticipate that the vaccine will be required for city residents.

We would not anticipate vaccine mandates in any setting, she said. I think time will tell as more vaccine becomes available on what decisions that have to be made in that regard.

Arwady also said that she hopes that those healthcare workers and other first responders who will be first in line for the vaccine will take advantage of that availability.

Im very hopeful that well see healthcare workers and others who get that early availability, and then essential workers, really taking advantage of the opportunity to protect themselves and their community. But this will be a choice that people will have, particularly early on, she said.

State officials have said throughout the pandemic that a hypothetical vaccine for the virus would not be required by law. The first doses of vaccine could be delivered to city and state health officials within the coming weeks, and officials at all levels are still working out details on which individuals will be the first to receive the treatment when it becomes available.

At the state level, healthcare workers will likely be the first to receive the vaccine, with residents and staff in congregant settings, including assisted living facilities and nursing homes, likely next on the list if the state gets enough doses in the first wave of vaccines.

Illinois Gov. J.B. Pritzker says that the state is not planning to mandate that residents receive the vaccine, but echoed Arwadys hopes that those individuals within groups that will receive the treatment first will elect to do so.

There arent any mandates in place, he said. Its certainly something that is always under discussion. What I know is that were going to be focusing on those populations that are most vulnerable, and also the people who treat the most vulnerable, and not just healthcare workers, but others who may work with the most vulnerable.

Even without a mandate for a vaccine, health officials are encouraging as many residents as possible seek out and receive the injections. Individuals who have been immunized against the virus could still potentially spread it, meaning that in order for the vaccine to be effective, a majority of state residents will need to receive it.

Dr. Ngozi Ezike, director of the Illinois Department of Public Health, has previously said that in order to achieve proper herd immunity in the state, up to 80% or more of the population will need to receive the vaccine.


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For some in Grand Forks County, COVID-19 vaccine could begin to roll out in mid-December – Grand Forks Herald

For some in Grand Forks County, COVID-19 vaccine could begin to roll out in mid-December – Grand Forks Herald

December 2, 2020

Debbie Swanson told Grand Forks County Commission members that biotech company Pfizer is awaiting emergency approval of its vaccine, and rival drug-maker Modernas vaccine is not far behind. Vaccinations will roll out in waves, with the first including health care providers and residents and staff of long-term care facilities.

The two vaccines, which Swanson said are about 95% effective, need to be kept in an ultracold environment, which poses certain challenges, but she expects vaccinations will occur within the timeframe that it can be refrigerated.

I think communication is just going to be the key that we know who everybody is, and we can contact them as the vaccine comes to us and we have priority groups that are ready to receive it, Swanson told the commission at its Dec. 1 meeting.

The North Dakota COVID vaccine ethics group will be meeting later in the week to discuss what groups will be included in Phase 2. Swanson said those groups likely will be essential workers, including teachers, law enforcement and firefighters, among others

On a cautious note, Swanson informed the commission there are mild side-effects of the vaccine, including having a sore arm and feeling sick. Health care institutions may need to spread out the vaccine among their workers to avoid having large numbers of similar employees calling in sick the next day.

Cases of coronavirus in the county have been trending down, according to Michael Dulitz, who is doing data analysis for the health department. The percentage of positive tests has fallen to 7.6%, a level not seen since early October.

Also, the doubling effect the time it takes for the number of cases to double has increased to 65 days, which Dulitz said is a positive move. In early November, data indicated there could be as many as 38,000 cases by January, as cases were expected to double every month or so.

I think we can safely say that we are on a downward trajectory right now, Dulitz said.

Dulitz said he doesn't know if a mask mandate is the reason for the decline in positive cases, and that it will take more time to tell. However, he said, wearing masks has caused declines in other states.

Still, while positive cases are slowing, the death rate is not, especially for those over 80. There have been 47 deaths in the county due to the illness, and 15 people have died in the last 17 days. People who were exposed earlier in the pandemic can receive treatment in the hospital for long periods of time before dying.

In other commission news from Tuesday's meeting:

Emergency Manager Kari Goelz reported she found a storage unit for stores of personal protective equipment and other supplies. Those supplies were previously stored in a city-owned building, but needed to be moved because of a renovation project. Goelz said she planted the seed of having the city pay for half, if not all, of the costs incurred to move the supplies.

The county will work with ICON Architectural Group to create a request for proposal, in preparation to solicit public bids for remodeling and COVID mitigation work at the County Office Building, as well as at the States Attorneys Office. Combined, the repairs nearly reach the $200,000 threshold requiring public bids. The repairs will be paid for with federal CARES Act funding given to the county.

Commissioners also selected Cynthia Pic to chair the board for the 2021 session, with Tom Falck being elected vice-chair.


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Newsfeed Now: Who will get first COVID-19 vaccines; La. COVID patient receives help from across the country – KHON2

Newsfeed Now: Who will get first COVID-19 vaccines; La. COVID patient receives help from across the country – KHON2

December 2, 2020

Posted: Dec 2, 2020 / 05:26 AM HST / Updated: Dec 2, 2020 / 05:58 AM HST

Weekdays at 10:30 a.m. CST/11:30 a.m. EST, Newsfeed Now will be streaming the top stories in the U.S. utilizing our newsrooms across the country. If you miss the live report, youll be able to see a replay minutes after the stream ends.

(NEXSTAR) A 14-member advisory panel voted Tuesday on who should get the COVID-19 vaccine first.

Dr. Kathleen Dooling, a member of the committee advising the Centers for Disease Control and Prevention, says the first doses will go to healthcare personnel and long-term care facility residents.

For more on this story: CLICK HERE.

Other stories in todays show:

CORONAVIRUS RELIEF COMPROMISE UNVEILED: A bipartisan group of lawmakers introduced its own coronavirus relief plan Tuesday with a promise that Congress will not leave for Christmas until a compromise is reached.

The $908 billion package includes $288 billion for small businesses, $180 billion in additional unemployment insurance, and $160 billion for state and local governments. It also has funding for schools, transportation, health care, and student loan and housing assistance.

For more on this story: CLICK HERE.

NATIONWIDE NURSING SHORTAGE: Its been an impossibly grueling year for the countrys healthcare workers. American hospitals are experiencing a shortage of nurses during the pandemic for a wide variety of reasons, and hospital systems across the country are now competing to get them back to work.

While the government currently has no concrete numbers on what the shortage truly looks like, anecdotal evidence straight from the source points to the severity of the need.

For more on this story: CLICK HERE.

MAN WITH COVID-19 RECEIVES HELP FROM ACROSS THE COUNTRY: A Louisiana man battling COVID-19 received help from across the country.

It all started with a post from his brother-in-law.

For more on this story: CLICK HERE.

Weekdays at 10:30 a.m. CST/11:30 a.m. EST, Newsfeed Now will be streaming the top stories in the U.S. utilizing our newsrooms across the country. If you miss the live report, youll be able to see a replay minutes after the stream ends.

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Newsfeed Now: Who will get first COVID-19 vaccines; La. COVID patient receives help from across the country - KHON2
Reassuring the skeptics: VCU infectious disease expert weighs in on COVID-19 vaccine – WWBT NBC12 News

Reassuring the skeptics: VCU infectious disease expert weighs in on COVID-19 vaccine – WWBT NBC12 News

December 2, 2020

The best thing you can do if you have the opportunity to get immunized is to get immunized, its the same reason that were asking people to mask up, said Hylton Gravatt. Its not just to protect you from contracting the virus, but also to protect from potentially infecting others.


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Coronavirus vaccines: Your questions answered – CNN

Coronavirus vaccines: Your questions answered – CNN

December 2, 2020

Vaccinations could begin in the United States in the second half of December, starting with high-risk groups and becoming available for the rest of the population in spring, according to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

Here are some answers to common questions about the coronavirus vaccines being developed to prevent Covid-19.

Don't vaccines take years to develop safely? How have these two been developed in just 10 months?

The pandemic has galvanized the scientific community all around the world, with groups of researchers in dozens of countries on a fast-paced hunt to understand how the virus works.

Operation Warp Speed has also drawn up protocols to allow trials to proceed more quickly, and industrial-scale manufacturing of the vaccines has taken place before we knew whether they would be effective. This means we have millions of doses ready to be used.

How effective is this vaccine?

In Moderna's trial, 15,000 study participants were given a placebo, which is a shot of saline that has no effect. Over several months, 90 of those people developed Covid-19. Another 15,000 participants were given the vaccine, and five of them developed Covid-19.

Among those receiving a placebo, 11 became severely ill, but none of the participants who received the vaccine became severely ill.

The head of the International Vaccine Institute has hailed biotech company Moderna's early data on its Covid-19 vaccine candidate, saying it is "proof of concept," but cautioned that it's still early days in terms of follow-up efficacy.

"I think it's really great news and in a way confirmation that the RNA vaccines are able to protect against infectious disease and it is also a good example again that Covid vaccines are a possibility," Dr. Jerome Kim, the institute's director general, told CNN on Monday.

"It will be really important to know what efficacy is - not at two months, but at six and twelve," Kim said.

There are still lots of unknowns about how the new coronavirus vaccines would work in practice. It's not clear whether they would prevent infection altogether or make severe illness less likely. Doctors also do not know how long their protection will last.

Vaccines have various efficacy rates. According to the US Centers for Disease Control and Prevention, a full round of polio vaccines is 99% to 100% effective; full vaccination against diphtheria, tetanus and pertussis is 80% to 90% effective, while the efficacy of flu vaccine varies from year to year.

How safe are the vaccines, and are there any side effects?

Moderna said its vaccine did not have any significant side effects. A small percentage of those who received it experienced symptoms such as body aches and headaches. It's similar to what people might experience after a flu shot and is a sign the vaccine is working to create an immune defense.

"They report no safety concerns - the main side effects are injection site pain, fatigue, muscle or joint aches and pains and headache which seemed to occur more frequently after the second injection," Dr. Penny Ward, a visiting professor in pharmaceutical medicine at King's College London, told the SMC.

"Clearly we still need to see the complete scientific details in a publication to be able to judge the outcomes independently."

How do these vaccines work? I'm worried they sound experimental.

Vaccines typically mimic part of the virus they protect against, prompting a response from your immune system.

The vaccines from Moderna and Pfizer both use a new approach that hasn't resulted in an approved vaccine before -- although they have been studied in clinical trials for other viruses.

The two vaccines use genetic code rather than any part of the virus itself, with a technique called messenger RNA, or mRNA. The vaccines deliver mRNA, which is a genetic recipe. In this case, the genetic recipe directs cells to make pieces of the spikes that sit atop the coronavirus. Once it's injected, the body's immune system makes antibodies that recognize these spikes. If a vaccinated person is later exposed to the coronavirus, those antibodies should stand at the ready to attack the virus.

The fact that Moderna and Pfizer have independently produced very similar results using the same technique is a vote of confidence in the genetic technology, experts said, and their results could make it much easier and quicker to produce other vaccines.

"Using this technology, vaccine candidates can be produced substantially faster in the future to combat virtually any infectious disease, by producing vaccines against both existing pathogens and future, currently unknown pathogens," Zoltn Kis, research associate at the Future Vaccine Manufacturing Hub, Imperial College London, told the SMC.

Other companies are developing vaccines using other techniques -- the Oxford/AstraZeneca vaccine is made from a harmless modified chimpanzee virus, while the traditional route is to use the inactivated virus.

Sign me up! When can I get it?

While Fauci said he expects the first Covid-19 vaccinations to begin toward the latter part of December, initially there won't be enough vaccine for everyone. The highest-priority groups, which include health care workers, the elderly and people with underlying medical conditions, will get the vaccine first.

"I think that everybody else will start to get vaccinated towards the end of April," Fauci said. "And that will go into May, June, July. It will take a couple of months to do."

The British government has asked the National Health Service, known as NHS, to be ready to deploy a vaccine from the beginning of December.

What if I'm old, pregnant or clinically vulnerable?

The study also includes more than 11,000 participants from communities of color, representing 37% of the study population, which Moderna said was similar to the diversity of the US population. This includes more than 6,000 participants who identify as Hispanic or Latinx, and more than 3,000 participants who identify as Black or African American.

Noubar Afeyan, the co-founder and chairman of Moderna, said the company doesn't see "any difference in the results," among the subgroups in its Covid-19 vaccine trials.

"Moderna actually slightly slowed down the trial recruitment to ensure that we had a substantial representation, and it turns out, 37% of our trials were people, were subjects, that are considered of color," Afeyan said on CNN International Monday.

"Generally, it looks like the vaccine performs broadly across all the population groups," Afeyan said.

However, we don't know anything about groups not involved in the trial such as children or pregnant women.

"Urgent questions remain to be answered, including how long these vaccines will be effective for and whether these vaccines work across different populations, in all age groups, ethnicities, and those with prior health conditions," said Charlie Weller, head of vaccines at medical research charity Wellcome.

"Only upon trial completion will we be able to assess the full efficacy and safety of any vaccine candidate."

Will the vaccines be compulsory? What happens if I decide not to get vaccinated?

If you decide against getting a vaccination, it does have wider implications. Not only will you not have protection against Covid-19, but it could potentially make it harder to achieve community, or herd, immunity. This protects high-risk groups that might not be able to get the vaccination.

It is estimated that a Covid-19 vaccine will need to be accepted by at least 55% of the population to provide community immunity, according to the London School of Hygiene & Tropical Medicine, and some scientists anticipate even higher numbers will be needed.


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Coronavirus vaccines: Your questions answered - CNN
Moderna to seek FDA emergency authorization after COVID-19 …

Moderna to seek FDA emergency authorization after COVID-19 …

December 2, 2020

Moderna announced Monday it will ask the Food and Drug Administration for emergency use authorization (EUA) for its COVID-19 vaccine, making it the second company, after Pfizer, to seek EUA for a COVID-19 vaccine in the United States.

Pfizer's public FDA hearing -- a crucial step in the authorization process -- is scheduled for Dec. 10, and the FDA could make its official authorization decision shortly thereafter.

In an early morning press release, Moderna announced that its FDA hearing will be held a week later, on Dec. 17. Moderna also announced its coronavirus vaccine is more than 94% effective, according to the final analysis of its massive Phase 3 trial.

Among the more than 30,000 volunteers in Moderna's Phase 3 trial, 196 ultimately developed COVID-19, but the vast majority of those COVID-19 cases happened among volunteers who had been given a placebo injection -- an imbalance hefty enough for biostatisticians to feel confident the vaccine is highly effective.

"The newly published results from Moderna confirm our enthusiasm for the prospects of their vaccine," said Dr. John Brownstein, an epidemiologist, chief innovation officer at Boston Children's Hospital and contributor to ABC News.

Pfizer said its vaccine was 95% effective in the final analysis, but it had a different number of COVID-19 cases in its trial, so the percentages shouldn't be compared head-to-head without context, experts say.

"The results of both trials are just amazing," said David Benkeser, an assistant professor of biostatistics and bioinformatics at Emory University Rollins School of Public Health.

He added that "94.1% and 95% are statistically indistinguishable at this point, probably coming down to a difference of just one or two cases of COVID-19."

"We do have to be careful not to over-interpret these data, especially when in comparison to the Pfizer analysis," Brownstein cautioned.

Syringe and bottle reading "Vaccine COVID-19" next to the Moderna biotech company logo, Nov. 18, 2020.

Moderna has promised to publish full details from the trial through a formal scientific review process. Additional details about the trial will become available through the FDA's review process, which the agency has pledged will be transparent to the public.

"While 94.1% efficacy is phenomenal, we are still dealing with small sample sizes and likely we will see differences in vaccine effectiveness when deployed in the population," Brownstein said.

But Monday's press release included some new details about Moderna's vaccine, including the fact that it appears to be equally effective among people of different races, ethnicities, ages and genders.

Among the 196 people who developed COVID-19 in the trial, 33 were older adults (ages 65 and up), 29 were Hispanic or Latino, six were Black or African American, four were Asian American and three were multiracial.

Moderna is also claiming that the Phase 3 data shows the vaccine was highly effective at preventing more severe cases of COVID-19. According to the press release, 30 out of the 196 volunteers developed severe illness, but all 30 were among the group of volunteers who got the placebo shot. This shows the vaccine demonstrated 100% efficacy at preventing severe COVID-19, according to the company.

According to Benkeser, this isn't enough data to prove Moderna's vaccine will prevent severe illness in every single person who receives it, "however, it is common for vaccines to be more effective against severe disease than mild disease," he said.

"The idea is that though a vaccine might not fully protect you against infection, it can make the subsequent illness less severe," he added. "Therefore, it really is quite plausible that the short-term efficacy against severe disease is indeed close to 100%."

Meanwhile, no serious safety concerns about the vaccine have been reported to date. People who get the vaccine may experience a sore arm, redness at the injection site, headache, fever, fatigue or other short-term adverse reactions.

Monday's announcement means Moderna is on track to see a possible FDA-authorized vaccine by the end of the year. The company is also on track to produce 20 million doses available for distribution around the U.S. by the end of December: enough doses to vaccinate 10 million people.

Moderna said it will also ask European regulators for a conditional approval, and the company is on track to manufacture 500 million to 1 billion doses globally in 2021.

Experts said that even the "final" analyses of both vaccine trials -- Pfizer's and Moderna's -- will not provide the final answer about just how well the vaccines will work, especially in the long term, but their results, both boasting greater than 90% efficacy, bode well for the future.

Benkeser said there is still a long way to go until vaccines are widely available, but when they are, Americans should trust the science.

"There's a light at the end of the -- as of yet -- very dark tunnel," he said, "but for the first time since March, I feel hopeful about turning a corner."


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Is the coronavirus vaccine made from fetal cell lines?

Is the coronavirus vaccine made from fetal cell lines?

December 2, 2020

Washington, D.C. Newsroom, Jul 28, 2020 / 04:00 pm MT (CNA).- As coronavirus vaccine prototypes move closer to testing and approval, some Catholics are debating the ethical sources behind a leading vaccine candidate.

On Monday, President Donald Trump announced that the vaccine mRNA-1273, co-designed by the biotechnology company Moderna and the National Institute of Allergy and Infectious Diseases (NIAID), had entered phase 3 of clinical trials. The vaccine will soon be tested for safety, and to confirm that it can effectively prevent COVID-19 in two doses.

Dr. Anthony Fauci, director of NIAID and White House health advisor, said on Monday that a vaccine is urgently required to control this pandemic, but has also cautioned in recent days that, despite speedy progress, a vaccine might not be widely available until several months into 2021.

The Trump administration is funding vaccine candidates as part of Operation Warp Speed, making investments in vaccine candidates from Novavax, Moderna, AstraZeneca, and Janssen. It is also investing $1.95 billion with Pfizer to facilitate the delivery of 100 million doses after a vaccine is developed.

On Monday Fauci said that early testing of the Moderna vaccine indicates that it is safe and immunogenic.

While demand for a vaccine is urgent, questions have been raised by some pro-life advocates about the Moderna candidate, and its ethical development - specifically, whether it has been tested using a fetal cell line taken from an aborted baby.

The Charlotte Lozier Institute, research arm of the pro-life Susan B. Anthony List, has listed the Moderna vaccine among the ethically uncontroversial CoV-19 vaccine programs, along with development projects from Inovio Pharmaceuticals, Sanofi & Translate Bio, Pfizer and BioNTech, Novavax, and Merck/IAVI.

According to CLI, two vaccine candidates are the product of unethical programsthose being developed by the University of Oxford and Astrazeneca, and by Johnson & Johnson and Janssen Res. & Devel., Inc.

On the straightforward question of whether the Moderna vaccine is being produced from cell lines from elective abortions, Dr. John Brehany, director of institutional relations at the National Catholic Bioethics Center, said it appears that the answer is no.

Vaccines use a weakened version of a disease, grown in laboratory cell lines, in order to inoculate someone against the disease. With some common vaccines, such as those used to fight chicken pox and measles, mumps, and rubella (MMR), the cell lines of babies who were aborted decades ago are used to grow the weakened diseases.

This is also reportedly the case with some coronavirus vaccines in development, such as one worked on by the University of Oxford and Astrazeneca, which relies on the HEK-239 cell lines from a baby aborted in the Netherlands in the 1970s. That program is also being funded by the Trump administrations Operation Warp Speed.

But the Moderna vaccine works in different way than most vaccines. Its method of innoculation is not based on using cells at all in production, Brehany said.

The Moderna vaccine relies upon a spike protein from SARS-CoV-2 to induce the production of antibodies in the recipient, instead of a weakened version of the disease.

The gene sequences for the spike protein were determined to be a good candidate for producing a vaccine.

Non-Moderna scientists had initially made DNA vectors with the gene sequence of the spike protein, and injected them in HEK-293 cells to produce the spike protein. That work was studied and evaluated by experts at NIAID and the University of Texas, who determined that the spike protein was a good candidate for testing. Moderna was not involved in the DNA construction nor was it involved in the evaluation of the construction.

Thus, Brehany said, while the company has some association with the use of cell lines from elective abortions, it is not responsible for that use, and its vaccine was not produced using those HEK-293 cells.

A 2005 document from the Pontifical Academy for Life considered the moral issues surrounding vaccines prepared in cell lines descended from aborted fetuses. The Vatican group concluded that it can be both morally permissible and morally responsible for Catholics to use these vaccines.

In general, doctors or parents who resort to the use of these vaccines for their children, in spite of knowing their origin (voluntary abortion), carry out a form of very remote mediate material cooperation, the pontifical academy said.

The duty to avoid passive material cooperation is not obligatory if there is grave inconvenience. Moreover, we find, in such a case, a proportional reason, in order to accept the use of these vaccines in the presence of the danger of favouring the spread of the pathological agent, due to the lack of vaccination of children, it added.

The pontifical academy also noted that Catholics have an obligation to use ethically-sourced vaccines when available, and have an obligation to speak up and request the development of new cell lines that are not derived from aborted fetuses.

The 2008 Congregation for the Doctrine of the Faith document Dignitatis personae strongly criticized aborted fetal tissue research. The CDF said that researchers should refuse the material even when they have no close connection to the actions of those who performed the artificial fertilization or the abortion.

This duty springs from the necessity to remove oneself, within the area of ones own research, from a gravely unjust legal situation and to affirm with clarity the value of human life, the CDF stated.

Regarding common vaccines, such as those for chicken pox and measles, mumps, and rubella (MMR), that may be derived from cell lines of aborted babies, the Vatican has said they could be used by parents for grave reasons such as danger to their childrens health.

Another ethical question at the heart of COVID vaccine production is the speed at which it is taking place.

The hurried development makes it all the more important that bioethicists scrutinize the vaccine, said NCBC president Joseph Meaney in a July 24 statement.

Good bioethicists are nearly always wary when scientific research is rushed forward, and even more so when the potential impact on human beings could be profound, he said.

Brehany echoed that point, telling CNA that a vaccine must be developed and distributed with the informed consent for all recipients about the possible risks, without testing on vulnerable populations especially the poor.

On April 17, leading U.S. bishops wrote Stephen Hahn, commissioner of the Food and Drug Administration (FDA), asking that a COVID vaccine be developed ethically.

It is critically important that Americans have access to a vaccine that is produced ethically: no American should be forced to choose between being vaccinated against this potentially deadly virus and violating his or her conscience, the bishops wrote.

The letter was signed was the chairs of the U.S. Catholic bishops committees on pro-life issues, doctrine, and domestic justice, and subcommittee on health care issues. Leaders of pro-life and bioethics groups, including the National Catholic Bioethics Center, the Catholic Medical Association, and the American College of Pediatricians, also signed the letter.

Brehany said that vaccines derived from cell lines of aborted babies is a very significant bioethical issue that Christians and pro-lifers ought to take seriously.

This is the time to be advocating for alternatives, he said of current COVID vaccine production and ethical sources for vaccines.

Around 30,000 people who are not COVID-positive will be enrolled in the phase 3 testing of the Moderna vaccine. The Food and Drug Administration (FDA) will then review the testing results.

In addition to the Moderna candidate, Trump said that four other vaccine candidates are expected to enter final trials in the coming weeks.


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Is the coronavirus vaccine made from fetal cell lines?
‘Wonderful news to wake up to:’ U.K. greenlights Pfizer’s COVID-19 vaccine – Science Magazine

‘Wonderful news to wake up to:’ U.K. greenlights Pfizer’s COVID-19 vaccine – Science Magazine

December 2, 2020

The United Kingdomhas bought 40 million doses of the Pfizer/BioNTech vaccine, enough for 20 million people. Health secretary Matt Hancock today announced that the first 800,000 doses will be available next week.

By Cathleen OGradyDec. 2, 2020 , 6:15 AM

Sciences COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.

The United Kingdoms Medicines and Healthcare Products Regulatory Agency (MHRA)announced todayit has granted emergency authorization for the COVID-19 vaccine developed by Pfizer and BioNTech, marking the first such approval outside of Russia and China.

It is only 12 months since the first recorded case of COVID-19, Arne Akbar, president of the British Society for Immunology, said in a public statement this morning. To achieve this within this timescale is remarkable and the researchers should be applauded.

The European Medicines Agency, which regulates drugs and vaccines in the European Union,said yesterdaythat its Committee for Medicinal Products for Human Use will meet on 29 December at the latest to discuss Pfizers data. (A similar meeting for its key rival, Moderna, will take place no later than 12 January 2021.) The U.S. Food and Drug Administration (FDA) has a meeting planned to discuss Pfizers data in depth on10 December. The early approval of a vaccine in the United Kingdom may further increase political pressure on FDA to speed up its authorization process; U.S. President Donald Trump hasreportedly already admonishedFDA Commissioner Stephen Hahn to do so.

It is only 12 months since the first recorded case of COVID-19. To achieve this within this timescale is remarkable and the researchers should be applauded.

MHRA will only become fully independent on 1 January 2021, following Brexit, butU.K. regulations allow it to grant authorizations on an emergency basis. The United Kingdom has bought 40 million doses of the Pfizer/BioNTech vaccineenough for 20 million peopleand health secretary Matt Hancock today announced the first 800,000 doses will be available next week. The rollout will prioritize health workers as well as the elderly and other vulnerable populations, but the Joint Committee on Vaccination and Immunisation has yet to offer its final guidance on the exact priorities.

Russia on 11 August allowed its COVID-19 vaccine, developed by the Gamaleya Research Institute of Epidemiology and Microbiology,to be used on certain groups of people, and China has granted emergency use authorizations for several vaccinesand has already vaccinated hundreds of thousands of peoplewith them.

The Pfizer vaccine, whose key ingredient is messenger RNA that encodes the spike protein of the pandemic coronavirus, was found to have95%efficacy, a clinical trial measurement of effectiveness,in a phase III trial in 43,000 people. But it presents logistical challenges for a widescale and rapid rollout, as it requires storage at 70C. The lesser demands of other vaccinesincluding a candidate developed by the University of Oxford and AstraZenecamean they will likely still play an important role in providing vaccinations for the whole U.K. populationand for global coverage, according to Michael Head, a global health researcher at the University of Southampton, but, for now, this is wonderful news to wake up to.


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'Wonderful news to wake up to:' U.K. greenlights Pfizer's COVID-19 vaccine - Science Magazine
Newsfeed Now: Who will get first COVID-19 vaccines; La. COVID patient receives help from across the country – WPRI.com

Newsfeed Now: Who will get first COVID-19 vaccines; La. COVID patient receives help from across the country – WPRI.com

December 2, 2020

Posted: Dec 2, 2020 / 10:25 AM EST / Updated: Dec 2, 2020 / 10:58 AM EST

Weekdays at 10:30 a.m. CST/11:30 a.m. EST, Newsfeed Now will be streaming the top stories in the U.S. utilizing our newsrooms across the country. If you miss the live report, youll be able to see a replay minutes after the stream ends.

(NEXSTAR) A 14-member advisory panel voted Tuesday on who should get the COVID-19 vaccine first.

Dr. Kathleen Dooling, a member of the committee advising the Centers for Disease Control and Prevention, says the first doses will go to healthcare personnel and long-term care facility residents.

For more on this story: CLICK HERE.

Other stories in todays show:

CORONAVIRUS RELIEF COMPROMISE UNVEILED: A bipartisan group of lawmakers introduced its own coronavirus relief plan Tuesday with a promise that Congress will not leave for Christmas until a compromise is reached.

The $908 billion package includes $288 billion for small businesses, $180 billion in additional unemployment insurance, and $160 billion for state and local governments. It also has funding for schools, transportation, health care, and student loan and housing assistance.

For more on this story: CLICK HERE.

NATIONWIDE NURSING SHORTAGE: Its been an impossibly grueling year for the countrys healthcare workers. American hospitals are experiencing a shortage of nurses during the pandemic for a wide variety of reasons, and hospital systems across the country are now competing to get them back to work.

While the government currently has no concrete numbers on what the shortage truly looks like, anecdotal evidence straight from the source points to the severity of the need.

For more on this story: CLICK HERE.

MAN WITH COVID-19 RECEIVES HELP FROM ACROSS THE COUNTRY: A Louisiana man battling COVID-19 received help from across the country.

It all started with a post from his brother-in-law.

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Dec. 1: Thirty-one New COVID-19 Cases in Evanston, 12278 in the State – Evanston RoundTable

Dec. 1: Thirty-one New COVID-19 Cases in Evanston, 12278 in the State – Evanston RoundTable

December 2, 2020

There was a significant jump in thenumber of new COVID-19 cases today in Evanston, Suburban Cook County, Chicago,and the State, compared to the average number of new cases in the prior fourdays. On a Statewide basis there were 12,542 new cases today, compared to anaverage of 7,229 in the prior four days.

Governor JB Pritzker said one reason forthe increase may be there were 133,444 tests today, compared to an average of64,955 in the prior four days. He added that part of the increase may be due toa spread of the virus due to travel and gatherings over the Thanksgivingholiday.

A surge in cases may be felt withinfive to 10 days after a holiday, and it may have an impact for as long as 28days.

Dr. Ngozi Ezike, Director of theIllinois Department of Public Health, said, We're seeing cases increase becausealthough so many people are wearing masks and being compliant, theres stillmany that aren't. So many people make difficult choices to forego Thanksgivingin a traditional way and observe virtual Thanksgivings in the hopes ofpreventing an ICU Christmas. But many did not. Many people are staying home asmuch as possible, but others are not. And these actions of moving about andmixing up households do allow the virus to spread more quickly, which meansthere's more opportunity for more cases."

Dr. Ezike said the chances thathospitals and health care workers will be overwhelmed would be reduced ifpeople followed the mitigations in place, wore masks, and maintained six feetof distance.

Prioritiesfor Vaccines

While the briefing was in progress,the CDC was meeting to consider the allocations of the initial shipments of vaccinesthat still have to be approved, and who should be vaccinated first.

A panel of experts advising the CDCsaid long-term care residents and at-risk health care workers should get thefirst corona virus vaccines. The CDC is scheduled to decide by tomorrow.

Gov. Pritzker said this afternoon thatthe State was currently anticipating that it will receive 109,000 doses of vaccinesin the first shipment. Assuming each person would need two shots, that would beenough to vaccinate 45,000 people.

Gov. Pritzker said the first prioritywould be to vaccinate health care workers and then health care workers inlong-term care facilities. He said as soon as the CDC is able to deliver itsrecommendations about priority, we'll be able to take that into considerationin the way that we prioritize how the vaccines will be distributed acrossIllinois.

Gov. Pritzker said because the initialshipment will have only a limited number of doses, they will go almost all tohealth care workers. If there are enough doses, then they would go to thosein long term care facilities, the staff and the residents.

What I know is that we're going to befocusing on those populations that are most vulnerable, and also the people whotreat the most vulnerable, not just healthcare workers, but others who may workwith the most vulnerable, said Gov. Pritzker. Weve sometimes called themessential workers. We want to make sure that they're vaccinated as well.

Dr. Ezike said some of the high riskworkers or essential workers may include people who work in the ICU, or thepeople cleaning the room of a COVID patient, or the people stocking the shelvesin the grocery stores. There's a lot of people who are essential or criticalto making sure that life can continue, she said.

We absolutely will look at areas, regionsthat have had a large number of deaths per capita. We already know that AfricanAmericans are most likely to die. We have to be very intentional and lookingat all of these issues.

We're going to have months of trying to getthis vaccine out and we will continue to adjust, Dr. Ezike added, We willjust be adjusting the distribution and the allocations to try to get as many ofthose high risk people up front, but knowing that the goal is to get it toeveryone and hoping that there's going to be the will of the people to actuallyreceive it.

EVANSTON: 31 New COVID-19 Cases Today

Therewere 31 new confirmed COVID-19 cases of Evanston residents today, an increasefrom 8 yesterday. The average number of new cases per day in the last seven daysis 22.3. For purposes of comparison, on Oct.12, the seven-day average was 5.6.

Therehas been a total of 2,353 COVID-19 cases of Evanston residents during thepandemic, 331 of which are active. An accompanying chart shows the trend. [1]

Inthe last 7 days, there were a total of 156 new COVID-19 cases of Evanstonians.That equates to about 207 new cases per 100,000 people in the 7-day period. TheStates 7-day target is 50 per 100,000.

Thetest positivity rate over the last 7 days is 4.2%. The rate is up from 2.8% onNov. 1.

NoEvanstonian is reported to have died due to COVID-19 in the last 24 hours. Thenumber of deaths due to COVID-19 remains at 88.

The Impact of NU on Evanstons Increase inCases

AllNorthwestern University (NU) students, staff and faculty who live in Evanston andwho test positive for COVID-19 are included in the case numbers reported above,according to the City. If NU students,staff or faculty live outside Evanston, they are not included. [2]

NorthwesternUniversity has posted data on its website reporting that between Nov. 20 and Nov.26 there were 50 new confirmed COVID-19 cases of students, staff and faculty,which includes those who live outside of Evanston. Between Nov. 23 and 29, NU says there were 27cases. The City claims it does not know how many of these cases are people who livein Evanston. [2].

SUBURBAN COOK COUNTY, CHICAGO ANDILLINOIS

Severalkey metrics used by IDPH to measure the spread of COVID-19 are the trend of newcases, the number of new cases per 100,000 population, and the test positivityrate. Another key metric is the numberof hospitalizations due to COVID-19 and hospitals capacity to care for a surgeof new patients.

First, NewCases.In Suburban Cook County, there were 2,388 new COVID-19 cases today, and 2,565in Chicago, for a total of 4,953. Yesterday the reported cases were 1,175 forSuburban Cook County and only 384 in Chicago, for a total of 1,559.

In the State there were 12,542 new casesreported today, a big jump from the prior four days which had new cases of 7,574,7,873, 7,178, and 6,190.

Theaverage number of new cases per day in the last seven days is 9,521. This isdown from 12,343 on Nov. 13. While the trend has been down, the number of newcases is still very high.

Forpurposes of comparison, the average of new cases per day over the seven daysending on May 1 was 2,565, which was the previous high for the State, until theincreases in the last month. The 7-day average today is more than three timesthat.

Thetrends of new cases in Suburban Cook County, Chicago and the State are shown inaccompanying charts. One significant point is that the 7-day average of newcases for each of these public bodies has been flat or declining since aboutNov. 13. Whether the jump in cases today foretells a change in that trendremains to be seen.

Second, NewCases per 100,000 Population.This criterion measures the level of contagion in an area and whether it is ata level that can be contained and suppressed. IDPHs target is that there befewer than 50 new COVID-19 cases per 100,000 people in a geographic area in a7-day period. Harvards Global Health Institute (HGHI) and the Edmond J. SafraCenter say that a stay-at-home order is necessary when the weekly cases exceed169. [3]

Inthe 7-days ending Dec. 1, the number of new cases per 100,000 people were as followsfor the areas indicated:

-SuburbanCook County: 493 (compared to 97 on Oct.1 )

-Chicago:422 (compared to 86 on Oct. 1)

-Illinois:511 (compared to 111 on Oct. 1)

Thenew cases are four times the number for the week ending Oct. 1, and each is atleast eight times IDPHs target.

Anaccompanying chart shows the trend in the number of new cases during the weekending Dec. 1, compared to the number of new cases for the weeks ending Oct. 1and Nov. 24. [4]

Importantly,the chart shows that while the number of new cases per 100,000 is still veryhigh, the number of new cases per 100,000 on Dec. 1 is lower than the number onNov. 24 for Suburban Cook County, Chicago, and the State. The seven-day trend of new cases is still declining.

Third, a Test Positivity Rate. IDPHs target is that the test positivity rate be5% or less, although HGHI and other leading experts say it should be 3% orless. If a communitys test positivityrate is high, it suggests that the community is not testing enough and notlocating people who have milder or asymptomatic cases and who may be spreadingthe virus. [5]

Themost recent 7-day test positivity rates as of Nov. 30 are as follows:

-SuburbanCook County: 12.4%

-Chicago:11.5%

-Illinois:12.2%

Eachpositivity rate has been declining in the last 10 days. But each is still morethan double IDPHs target and each is almost four times that of other leadingexperts. An accompanying chart highlights the rates.

Fourth, HospitalAdmissions and Surge Capacity.There were 2,836 hospitalizations due to COVID-19 in Suburban Cook County andChicago as of Nov. 30, up from 1,456 on Nov. 1.

IDPHreported that as of Dec.1, Suburban Cook County has a surplus capacity of 24%of medical/surgical beds and 20% of ICU beds; and Chicago has a surpluscapacity of 22% of medical/surgical beds and 25% of ICU beds. IDPHs target is 20%surplus capacity.

Ona Statewide basis, the number of hospitalizations due to COVID-19 was 5,835, asof midnight on Nov. 30. The number is down from an all-time high of 6,171 on Nov. 23. A chart in the chart boxshows the trend.

Forpurposes of comparison, the highest number of hospitalizations due to COVID-19 inthe spring was 4,868 on May 6. The number of hospitalizations today is almost1,000 more than the peak last spring.

Thenumber of patients using ICU beds is 1,195, up from 347 on Sept. 1. Patients onventilators is 721, up from 142 on Sept. 1.

Ifadditional hospital beds are needed in Suburban Cook County and Chicago, thecontingency plan is to increase bed capacity by doing the same things that weredone in the spring, Gov. Pritzker said on Nov. 10.

Fifth: Numberof Tests: Theaverage number of tests per day in the last seven days is 91,591. This ishigher than HGHIs mitigation level testing target, but about only about 45%of the amount needed to meet HGHIs suppression level testing target. [6].

Thenumber of new tests reported today was 133,444. This includes antigen tests.

Sixth: Delaysin Getting Test Results:Public health experts convened by HGHI and Edmond J. Safra Center say testresults should be obtained within 24 hours.

Dr.Ezike said on Nov. 12 that 53% of the lab tests come back in 48 hours, an indicationthat the results on almost half of the cases are coming in later. With thesurge in the number of tests being administered, the lag time is gettinglonger, said Gov. Pritzker on Nov. 25.

Asaliva test developed at the University of Illinois can produce results in 3 to6 hours, and it is being used at U of I, Champaign. [7] Gov. Pritzker said the plan is to expand thismethod of testing across the State, especially to other college campuses.

Thenew antigen tests being distributed by IDPH can generate results in 15 minutes.

Seventh: ContactTracing. Widespread contact tracing isalso essential to control the spread of the COVID-19 virus. IDPH posted data onNov. 27 showing the amount of contact tracing done in the period Aug. 1 throughNov. 21.

ForSuburban Cook County, contact tracers attempted to interview 16% of the peoplewho tested positive for COVID19, and interviewed 12% of them. Of the closecontacts identified by the people who tested positive, contact tracersattempted to call 62% and interviewed 55%

ForChicago, contact tracers attempted to interview 31% of the people who testedpositive for COVID19, and interviewed 16% of them. Of the close contactsidentified by the people who tested positive, contact tracers attempted to call61% and interviewed 34%.

Deaths: There were 125 deaths Statewide in the last 24hours, and a total of 12,403 deaths due to COVID-19 during the pandemic.

Forthe last seven days the number of deaths in the State, as adjusted, are 155,131, 66, 107, 57, 85, and 125 today.

.,

FOOTNOTES

1/ Antigen Tests. The Illinois Department ofPublic Health announced on Oct. 15 that is including both molecular (PCR) andantigen tests in the number of statewide total tests performed in Illinois, andthat it is including the positive test results on antigen tests in theconfirmed COVID-19 cases reported. Previously, due to the limited numberof antigen tests and limited information about antigen test accuracy, antigentests were not included in the total number (which comprised less than 1% oftotal tests performed).Antigen tests, like BinaxNOW, are now becomingmore readily available, therefore, IDPH will include both molecular and antigentests in its total number of tests starting October 15, 2020, said theIllinois Department of Public Health.Dr. Ngozi Ezike, Director of IDPH,said on October 30, You have COVID if you come up with a positive on the antigentest. Gov. JB Pritzker said it is very, very likely that a person hadCOVIC-19 if they test positive on an antigen test. The States plan is toadminister 3 million antigen tests provided by the federal government by theend of this year.

Dr.Michael Mina, assistant professor of epidemiology and assistant professor ofimmunology and infectious diseases at the Harvard T. H. Chan School of PublicHealth, said an antigen test detects if there is an antigen which is one of theproteins in the virus, while the PCR test looks for the RNA of the virus.

2/Northwestern University Covid-19 Cases. Ike C.Ogbo, Director ofEvanstons Health & Human Services Department, told the RoundTable that theCOVID-19 cases reported by the City include cases of faculty, staff andstudents attending Northwestern University who live in Evanston. The RoundTableasked the City in an FOIA Request to provide the number of NU students whotested positive for COVID-19 and who live in Evanston. The City refused toprovide the data. On Oct. 26, the RoundTable appealed the Citys decision tothe Public Access Counselor of the Attorney Generals Office. On Nov. 13, theCity filed a response claiming it does not have any records showing the numberof NU students who tested positive for COVID-19 and who live in Evanston.

TheRoundTable has asked Northwestern University on two occasions to provideinformation breaking out the number of new COVID-19 cases of its faculty, staffand students by residency in Evanston. NU did not respond to either request.

3/ Number of Cases per 100,000 Population. OnJuly 1, a network of research, policy and public health experts convened byHarvards Global Health Institute and Edmond J. Safra Center published a KeyMetrics for COVID Suppression framework that provides guidance to policy makersand the public on how to target and suppress COVID-19 more effectively acrossthe nation. The targets for new Covid-19 cases per 100,000 people are asfollows (these are converted from cases per day to cases per week): a) lessthan 7 cases: on track for containment; b) 7 to 63 cases: community spread,rigorous test and trace program advised; c) 70 to 168 cases: acceleratedspread, stay-at-home orders and/or rigorous test and trace programs advised;and d) 169+: tipping point, stay-at-home orders necessary. The article is available here: https://globalepidemics.org/key-metrics-for-covid-suppression/

IDPHprovides these categories and ratings: 1) minimal less than 50 cases per100,000 in a week; 2) moderate between 50 and 100 cases per week; and 3) substantialmore than 100 cases per 100,000 in a week.In its Metrics for School Determination of Community Spread, IDPH saysthe target is 50 cases per week per 100,000 people.

4/Calculations. The RoundTable calculated the number of cases per 100,000 usingcase data provided by IDPH and assuming that the population of Suburban CookCounty is 2.469 million, that the population of Chicago is 2.710 million, andthat the population of Illinois is 12.671 million.

5/The Test Positivity Rate. On May 26,Johns Hopkins University & Medicine Coronavirus Resource Center said on itswebsite that the World Health Organization (WHO) advised governments [on May15] that before reopening,rates of positivity in testing (i.e., out ofall tests conducted, how many came back positive for COVID-19) should remain at5% or lower for at least 14 days.

JohnsHopkins explains, The rate of positivity is an important indicator, because itcan provide insights into whether a community is conducting enough testing tofind cases. If a communitys positivity is high, it suggests that thatcommunity may largely be testing the sickest patients and possibly missingmilder or asymptomatic cases. A lower positivity may indicate that a communityis including in its testing patients with milder or no symptoms. Link: https://coronavirus.jhu.edu/testing/testing-positivity

The Harvard Global Health Institute (HGHI)says, A network of research, policy, and publichealthorganizationsconvened by Harvard and MIT called the TTSICollaborativehas agreed on a 3% test positive rate or below as a keyindicator of progress towards suppression level testing. This targets broad andaccessible testing for symptomatic and asymptomatic people. Out of the positivetests that do not come from hotspot testing, at least 80% should come fromcontact tracing.

Whilestating the test positivity target is 5% or less, IDPH provides thesecategories and ratings: 1) Minimal test positivity rate is equal to or lessthan 5%: 2) Moderate test positivity rate is between 5% and 8%; and 3)Substantial test positivity rate is over 8%. In its Metrics for SchoolDetermination of Community Spread, IDPH says the target is 5%.

6/How Much Testing Should be Done. The HarvardGlobal Health Institute posted a paper showing testing targets as of October 1,2020. The targets for Illinois are 438 tests per 100,000 people to meet themitigation target and 1,602 tests per day to meet the suppression target.The paper says that Illinois 7 day average of testing is 564 tests per day.Link to paper: https://globalepidemics.org/october-1-testing-targets/

MitigationLevel Testing: In an earlier paper, HGHI says for mitigation level testing,The focus is on reducing the spread of the virus through broad testing ofsymptomatic people, tracing and testing a recommended 10 contacts per new caseand isolating positive contacts, and social distancing, mask wearing orstay-at-home orders as necessary.

Thereis a challenge with this approach: As states open up, mitigation level testingis often not sufficient to prevent new outbreaks.

Withstrict social distancing orders in place, cases go down, but then spike back upagain as a state loosens restrictions. It's a rollercoaster of recurringoutbreaks that creates great uncertainty, for example around reopeningbusinesses, schools, and other vital parts of the economy.

SuppressionLevel Testing: HGHI says, Suppression level testing allows a state orcommunity to quickly find and isolate new cases before they lead to a wideroutbreak, with an aim of keeping new case levels at or near zero.

Thisrequires large, proactive testing -- including regular testing of asymptomaticpeople in high-risk environments such as nursing homes, colleges, and parts ofthe service industry -- paired with rapid contact tracing and supportedisolation (TTSI), as well as other measures.Several states are workinghard to build and maintain this type of response, including Massachusetts, NewYork and Connecticut.

Suppression level TTSI programs reduceuncertainty and allow life to return to something closer to normal -- but stillinclude mask-wearing, social distancing, handwashing and other measures. It iseasier to do when case counts are relatively low or on the decline.

Linkto HGHIs report: https://globalepidemics.org/july-6-2020-state-testing-targets/

7/ Saliva-based Tests. On Aug. 19, theUniversity of Illinois received emergency use authorization from the Food andDrug Administration to run a saliva-based COVID-19 test. The saliva test isless expensive, faster, and requires significantly less raw materials thantraditional testing, said Gov. JB Pritzker. If ongoing research continues toyield positive results, this has potentially game changing implications for ourState-wide testing complex as well as for testing on a national level,particularly for our high risk communities and settings.

Thistype of scalable product would allow us to mass deploy testing, and bettertrack and contain the spread of COVID-19. We're already working to deploy thisto more public universities across the State over the next weeks and months andexploring rolling this out to do testing potentially for K-12 schools and evenmore testing at our long-term care facilities, said the Governor.

Dr.Martin Burke, who put the research team together that developed the test, said thatin a trial run in July, they were able to get very fast test results, in manycases in 3 to 6 hours, which enabled them to rapidly isolate people who wereinfected with the virus and to contact trace. They were able to reduce the testpositivity rate from 1.5% to 0.2% during the month, he said.

Dr.Burke said speed is the key. The test is very well suited to scalabilityand the cost is about $10 a test. He added that the University has capacity toadminister 20,000 tests a day. Link: https://evanstonroundtable.com/Content/City-News/City-News/Article/Illinois-rapid-saliva-test-for-COVID-19-now-operating-under-FDA-Emergency-Use-Authorization/15/26/18440


See original here: Dec. 1: Thirty-one New COVID-19 Cases in Evanston, 12278 in the State - Evanston RoundTable