How Covid-19 Might Spread to You

[S Landreth]

• Connecticut study finds restaurants are top source of COVID-19 clusters

Cases of the novel coronavirus are surging in Connecticut, where about 80% of the state's population is now living under "red alert" status. And now, the state Department of Health is releasing results of a study investigating where COVID-19 is spreading.

Health officials are keeping track of "epidemiologically-linked clusters" and then categorizing them by setting of exposure, and restaurants, workplace, home, and places of worship were the top four locations.

Officials say when it came to restaurants as the top spreaders, nearly all of those cases were among workers. It's also worth noting that healthcare settings and institutions of higher learning were not included in the report.

"We are asking more questions about where people have been and trying to collect more information on venues, but in particular, where the outbreak team is focused on his work," said Dr. Lynn Sosa, with the Department of Public Health.

The health department looked at 69 different clusters, and contact tracing revealed restaurants were responsible for 20 of them. Workspaces were second with 14, and home spaces were blamed for 12.

Members of the Restaurant Association said they would like to do a deeper dive into the data to see exactly where it is being spread inside the restaurants.

"Employees are everything," Executive Director Scott Dolch told ABC affiliate WTNH. "The risks that they take, going down the road every day, and that's where we start with, and that's where it seems like the information is that related.": https://abc7ny.com/health/restaurant...sters/7919132/

• Coronavirus Cases: 53,468,481

Deaths: 1,304,963

Underreported US death count: 248,835

American Civil War Casualties (North and South) - 214,938

it's been blown way out of proportion.

[S Landreth]

• Another case of COVID-19 reinfection discovered in new study

A healthcare worker in Pakistan seems to have been reinfected with the novel coronavirus four months after first being infected, according to a recent study. It joins a series of studies around the world which have found evidence of reinfection with the virus.

The study, led by Khyber Medical University Vice-Chancellor Prof Ziaul Haq, found that a 41-year-old healthcare worker working in Islamabad tested positive for the coronavirus on June 6 with flu-like symptoms and was cleared of COVID-19 on June 19 with reactive antibodies, according to Pakistani newspaper Dawn.

Some four months and 13 days later, the same worker was found to be once again infected with the virus with severe symptoms and non-reactive antibodies.

The study, titled "COVID-19 reinfection in Pakistan" was published in the Journal of the Ayub Medical College, Abbottabad.

“It is not clear yet whether SARS-CoV-2 infection produces long-term immune protection or a short-lived immunity that would fade with the passage of time,” said Haq, according to Dawn.

"I repeat my stand: we shouldn’t declare a pre-mature victory against coronavirus and continue with the preventive measures regardless of the age, comorbidity or previous infection,” added Haq.

Cases of suspected reinfection were reported in Pakistan in October and have been reported across the world in recent months, with some patients experiencing more severe symptoms or even dying after the suspected reinfection. It remains unclear how long immunity lasts with the novel coronavirus and how common reinfection is.

Health minister of Pakistan's Sindh province, Dr Azra Pechuho, stated in October that asymptomatic patients were testing positive again for the coronavirus with severe symptoms.

“People should religiously follow precautionary measures as the second attack of the virus caused chronic infection and complications, especially in elderly people,” said Pechuho, according to the Pakistani newspaper, The News.

The leader of the Pakistan Peoples Party, Rashid Rabbani, died after contracting COVID-19 for a second time within a period of six months, according to Pechuho, who added that "many people" were not forming antibodies after being infected.

In October, a case report published by Oxford University Press reported that an 89-year-old woman from the Netherlands died after she was infected with the novel coronavirus for a second time. This marked the first recorded case of a reinfected patient dying due to the virus.

The woman suffered from a rare white blood cell cancer and, although she was not tested in between the two infections to see if she was negative for the virus, researchers found that the viruses in the two instances of infection were different strains.

A 25-year-old patient with no underlying conditions also had a more severe case of COVID-19 after he was reinfected.

"Previous exposure to SARS-CoV-2 might not guarantee total immunity in all cases. All individuals, whether previously diagnosed with COVID-19 or not, should take identical precautions to avoid infection with SARS-CoV-2. The implications of reinfections could be relevant for vaccine development and application," wrote the researchers in the Oxford University Press publication.

A recent study in Iceland showed that antibodies to the novel coronavirus didn't decline within four months of infection.

The Dutch patient and the patient in Nevada were both reinfected within two months.

Some Israelis who seemingly recovered from COVID-19 and then fell sick with symptoms a second time told Channel 12 in September that the second round was more difficult.

Prof. Arnon Ofek, deputy director-general of Sheba Medical Center, told Channel 12 that while this kind of situation is relatively rare, it is showing up in literature around the world.

"The first case was in Hong Kong, but there were also cases in Nevada and other places. Some of the cases were lighter but some were more severe."

"We don't really know everything about the virus and it will still surprise us in many things. In the end, immunity is created but it is different between people. We believe that there is a degree of protection," said Ofek. "This also has importance regarding the vaccine: We know that people will need two doses and that we will have to vaccinate again in X [amount of] time."

Cases of suspected reinfection with the novel coronavirus have been reported multiple times in Israel, with the first case reported as early as May.: https://www.jpost.com/health-science...w-study-649146

• Coronavirus Cases: 54,401,226

Deaths: 1,319,332

Underreported US death count: 251,256

American Civil War Casualties (North and South) - 214,938

it's been blown way out of proportion.

[S Landreth]

• Moderna's COVID-19 Vaccine Shines In Clinical Trial

A second COVID-19 vaccine now also appears highly effective in preventing illness following exposure to the virus that causes the disease.

The biotech company Moderna, Inc., said Monday that its experimental vaccine was 94.5% effective in preventing disease, according to an analysis of its clinical trial.

The news comes a week after Pfizer and BioNTech said their vaccine was more than 90% effective.

The results for both vaccines come from interim analyses of large clinical studies. In the Moderna study there were 30,000 volunteers. Half got two doses of the vaccine 28 days apart, half got two shots of a placebo on the same schedule.

There were 95 instances of COVID-19 illness among the study participants — only five of those cases were in the vaccinated group. Ninety were in the group receiving the placebo. Of these, there were 11 cases of severe disease. The results indicate the vaccine was inducing the kind of immune response that protects people if they were exposed to the coronavirus.

"This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease," said Stéphane Bancel, chief executive officer of Moderna, in a statement.

Both the Moderna and Pfizer vaccines use the same technology to make their vaccines. It's based on a molecule known as mRNA, or messenger RNA. That molecule contains genetic instructions for making proteins inside cells.

For the vaccine, researchers created an mRNA with the code for making the coronavirus spike protein. The protein is the key to the virus infecting cells. It's also what can trigger someone's immune system to make antibodies against the virus, but without causing infection since the rest of the virus is missing.

That two mRNA vaccines appear to be working is remarkable, since the technology is new and there hasn't been an mRNA vaccine approved by the Food and Drug Administration made to date.

The Moderna and Pfizer studies were conducted using slightly different protocols. To be counted as a COVID-19 case, participants in the Moderna study had to have at least two symptoms of disease in addition to a positive test for the virus. The Pfizer study required only one symptom. Also, Moderna waited 14 days following the second injection to begin counting cases; Pfizer's study started counting at seven days.

The vaccines also differ in their storage requirements. Moderna says its vaccine can be safely stored in freezers at about 25 degrees Fahrenheit (-4 degrees Celsius), a temperature easily reached by a home refrigerator freezer. Pfizer's vaccine required storage in specialized ultracold freezers capable of cooling below -94 degrees Fahrenheit (-70 degrees Celsius). Moderna also says its vaccine will remain potent for up to 30 days at normal refrigerated temperatures, which should ease distribution.

Both companies' vaccine studies managed to recruit a reasonably diverse group of people. Moderna reports that 6,000 enrollees who identified as Hispanic or Latinx participants, and more than 3,000 participants who identified as Black or African-American, as well as 7,000 people older than 65, and 5,000 with high-risk chronic diseases.

Pfizer and Moderna are still gathering safety data the Food and Drug Administration has said are necessary for consideration of an emergency use authorization that would allow the companies to distribute the vaccine during the pandemic.

Fauci Voices Cautious Optimism About Moderna Vaccine, Calling Trial 'Quite Promising' May 22, 2020

Side effects seen for the Moderna vaccine at the interim analysis included pain at the injection site, fatigue and aching muscles and joints. The data safety and monitoring board didn't identify "any significant safety concerns."

Moderna said it intends to file "in the coming weeks" with the FDA for authorization of the company's vaccine for emergency use.

The federal Operation Warp Speed project to hasten development of COVID-19 vaccines awarded Moderna a $1.5 billion contract in August to ramp up manufacturing and deliver 100 million vaccine doses, enough for 50 million people. The government has an option to buy up to 400 million more doses.

Moderna said Monday that it expects to be able to ship about 20 million vaccine doses in the U.S. by the end of 2020. Next year, the company said it expects to be able to make 500 million to 1 billion doses worldwide.

The research and development of the Moderna vaccine was aided by $955 million in federal funding from the Biomedical Advanced Research and Development Authority. Moderna has also been developing this vaccine alongside the National Institute for Allergy and Infectious Diseases, which in July told NPR it expects to spend about $410 million on the effort.: https://www.npr.org/sections/health-...clinical-trial

• Coronavirus Cases: 54,978,057

Deaths: 1,326,860

Underreported US death count: 251,935

American Civil War Casualties (North and South) - 214,938

it's been blown way out of proportion.

[S Landreth]

• FDA authorizes first COVID-19 test that gives results at home

The Food and Drug Administration (FDA) has issued an emergency use authorization for the first COVID-19 diagnostic test that it said can be fully administered at home.

The agency announced the authorization on late Tuesday for Lucira’s COVID-19 All-In-One Test Kit, which can be used for individuals at least 14 years of age or older.

The test, the agency said, works “by swirling the self-collected sample swab in a vial that is then placed in the test unit."

"In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus. Positive results indicate the presence of SARS-CoV-2,” the agency added.

At this time, the agency said the test is only authorized for prescription use.

FDA Commissioner Stephen M. Hahn said in a statement that the newly authorized test is the “first that can be fully self-administered and provide results at home."

“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” he also said, while adding the new announcement “underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”

Jeff Shuren, M.D., J.D., director of the agency’s Center for Devices and Radiological Health, also called the test’s authorization “a significant step toward FDA’s nationwide response to COVID-19.”

“A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic. Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them,” he said.

The news comes as the nation has seen an uptick in COVID-19 cases, in addition to a rise in hospitalizations, in recent days as the country heads into the colder months.: https://thehill.com/policy/healthcar...esults-at-home

• Coronavirus Cases: 55,204,177

Deaths: 1,330,159

Underreported US death count: 252,230

American Civil War Casualties (North and South) - 214,938

it's been blown way out of proportion.

[S Landreth]

• Pfizer To Seek FDA OK For COVID-19 Vaccine 'Within Days'

Pfizer is ready to ask the Food and Drug Administration to authorize emergency use of the company's COVID-19 vaccine, after an updated analysis of the clinical trial data found the vaccine to be 95% effective.

The results from the final efficacy analysis of the vaccine study were released Wednesday. An interim analysis released Nov. 9 had indicated the vaccine was more than 90% effective.

In the Phase 3 study involving more than 43,000 volunteers, half received the experimental vaccine and half got a placebo. Participants received two shots, spaced 21 days apart.

In a news release describing the trial, Pfizer and its partner BioNTech reported there were 170 cases of COVID-19 among the participants: 162 cases in the people who got the placebo compared with eight seen in volunteers who got the vaccine. Ten cases of severe COVID-19 were seen in the trial: nine of them occurred in the placebo group and one was in the vaccinated group.

The companies said the vaccine's efficacy held up across gender, race, ethnicity and various ages. In people older than 65, a group at elevated risk from COVID-19, the efficacy was 94%.

To assess vaccine safety, the FDA told companies that it wanted two-month follow-up data on at least half of the people in Phase 3 trials before considering applications to authorize emergency use of a vaccine during the pandemic. Pfizer said it had met the FDA milestone.

The most common significant side effect seen in the study was fatigue, at a frequency of 3.8% after a second dose of the vaccine. No serious safety concerns were observed, the company said.

"The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic," Pfizer Chairman and CEO Albert Bourla said in the release.

The companies' release said they plan to file for an emergency use authorization "within days" with the FDA. Agency officials have said an outside panel of experts would meet publicly to evaluate any COVID-19 vaccine and advise the agency on whether to grant an EUA. The agency's review process is expected to take weeks.

The companies expect to be able to make up to 50 million vaccine doses, enough for 25 million people, by the end of 2020. Next year's production would be up to 1.3 billion doses, or enough for 650 million people.: https://www.npr.org/sections/health-...ne-within-days

• Coronavirus Cases: 56,012,018

Deaths: 1,345,032

Underreported US death count: 254,291

American Civil War Casualties (North and South) - 214,938

it's been blown way out of proportion.

[S Landreth]

• Oxford-AstraZeneca Covid vaccine shows robust immune response among older adults

The coronavirus vaccine being developed by the University of Oxford and AstraZeneca is safe and triggers a similar immune response among all adults, according to the preliminary findings of a peer-reviewed phase two trial.

The promising early-stage results were published Thursday in The Lancet, one of the world’s top medical journals.

The study of 560 healthy adults, including 240 over age 70, found the vaccine to be safe and produced a similar immune response among people age over 56 and those ages 18 to 55.

Older people face a “significant risk” of developing severe illness on contracting Covid-19, the WHO has said, citing decreased immune function and potential underlying health conditions. People of all ages are at risk of contracting the virus, however.

AstraZeneca, which is working the University of Oxford, has previously said interim data showed their experimental vaccine had produced an immune response in older and younger adults.

“We’re really delighted with the results,” professor Andrew Pollard, the head of Oxford’s vaccine trial team, told reporters Thursday.

“In this study, we have … been trying to examine the immune responses in older adults and address this question that has been out there about as you get older whether the immune system is less able to respond,” Pollard said.

“And these first data are really encouraging … showing that we are getting very good immune responses — even in the over 70s, which look very similar to those in younger adults.”

A safe and effective vaccine is seen by many as a game changer in the battle against the coronavirus pandemic, which has claimed the lives of over 1.3 million people worldwide.

Huge challenges remain before a vaccine can be rolled out. The global battle to secure prospective supplies has raised alarm about equitable access, while questions remain over logistics, distribution, and cost.

The Oxford vaccine candidate was found to cause few side effects and triggered immune responses in parts of the immune system in all age groups and at low and standard doses.

The preliminary results showed that the vaccine — ChAdOx1 nCoV-19 — prompted what’s known as a “T-cell response” within 14 days of the first dose and an antibody response within 28 days of the booster dose. Scientists expect T-cell responses to play a role in long-term immunity against the virus.

Dr. Maheshi Ramasamy, a co-author of the study at the University of Oxford, said the antibody and T-cell responses among older adults were “robust” and “encouraging.”

“The populations at greatest risk of serious Covid-19 disease include people with existing health conditions and older adults,” Ramasamy said.

“We hope that this means our vaccine will help to protect some of the most vulnerable people in society, but further research will be needed before we can be sure.”

Study limitations

The authors of the study said their results could be encouraging if the immune responses are found to be associated with protection against Covid infections. The phase two trial did not assess vaccine efficacy, however, and phase three trials are ongoing to confirm this.

Results are expected later this year depending on the rate of infection within clinical trial communities.

The authors noted some limitations to their study, including that participants in the oldest age group had an average age of 73 to 74 and few underlying health conditions, and almost all participants were White and nonsmokers.

People from a range of backgrounds, countries, and ethnicities were said to be included in the phase three trial.

The study comes days after two other vaccine makers announced encouraging results from phase three trials. They said their experimental vaccines were found to be highly effective in protecting against the coronavirus, boosting optimism at a time when health systems in Europe and the U.S. are once again being pushed to breaking point.

Pfizer and BioNTech said Wednesday a final analysis found their vaccine candidate was 95% effective in preventing Covid and appeared to fend off severe disease. Earlier this week, Moderna said preliminary phase three trial data showed its vaccine was 94.5% effective.: https://www.cnbc.com/2020/11/19/oxfo...lts-study.html

• Coronavirus Cases: 56,774,409

Deaths: 1,358,413

Underreported US death count: 256,479

American Civil War Casualties (North and South) - 214,938

it's been blown way out of proportion.

[S Landreth]

• Covid reinfection ‘highly unlikely’ for at least six months, Oxford study says

People who have contracted the coronavirus are “highly unlikely” to contract the disease again for at least six months, according to a new Oxford study.

Researchers say the findings are “exciting” because they represent an important step in understanding how Covid-19 immunity may work.

The study, published Friday, claims to be the first large-scale research into how much protection people get against reinfection after contracting the coronavirus. It was part of a major collaboration between the University of Oxford and Oxford University Hospitals NHS Foundation Trust but has not yet been peer reviewed.

It comes after a string of encouraging vaccine results over the past couple of weeks following late-stage trial readouts from Pfizer-BioNTech and Moderna, as well as positive phase two results from AstraZeneca-Oxford.

There is growing optimism that a Covid vaccine could help bring an end to the coronavirus pandemic that has claimed over 1.3 million lives worldwide.

Public health officials and experts have warned it could take months, maybe even more than a year, to distribute enough doses of any prospective vaccine to achieve so-called herd immunity and suppress the virus.

The study covered a 30-week period between April and November with 12,180 health-care workers employed at Oxford University Hospitals.

The workers were tested for antibodies to the virus that causes Covid-19 as a way of detecting who had previously been infected. They were tested for the disease when they became unwell with symptoms and as part of regular testing.

The findings showed 89 of 11,052 staff without antibodies developed a new infection with symptoms. However, none of the 1,246 staff with antibodies developed a symptomatic infection. Staff with antibodies were also found to be less likely to test positive for the virus without symptoms.

“This is really good news, because we can be confident that, at least in the short term, most people who get COVID-19 won’t get it again,” said professor David Eyre of the University of Oxford’s Nuffield Department of Population Health.

In addition, researchers said the opposite also proved to be true. Health workers who did not have antibodies against Covid were found to be more likely to develop the infection.

Researchers said there was not yet enough data to make a judgment on protection from the initial infection beyond a six-month period. The study will continue to collect data, with the hope of verifying how long protection from reinfection can last.

“This is an exciting finding, indicating that infection with the virus provides at least short-term protection from re-infection — this news comes in the same month as other encouraging news about COVID vaccines,” said Dr. Katie Jeffery, director of infection prevention and control for Oxford University Hospitals.

A previous study of staff at Oxford University Hospitals NHS Foundation Trust, published on Nov. 5, found antibodies to Covid-19 fell by half in less than 90 days.

That study, which has also not yet been peer reviewed, said antibody levels peak lower and fall faster in younger adults.

“We know from a previous study that antibody levels fall over time,” Eyre said, referencing the research published earlier this month.

“But this latest study shows that there is some immunity in those who have been infected. We will continue to follow this cohort of staff carefully to see how long protection lasts and whether previous infection affects the severity of infection if people do get infected again.”: https://www.cnbc.com/2020/11/20/covi...tudy-says.html

• Coronavirus Cases: 57,611,613

Deaths: 1,371,766

Underreported US death count: 258,880

American Civil War Casualties (North and South) - 214,938

it's been blown way out of proportion.

[S Landreth]

Obese people at higher risk of contracting coronavirus, suggests study

The effects of cardiovascular risk factors on the risk of Covid-19 infection have been investigated through a novel approach by researchers at Queen Mary University of London.

Several observational studies have reported the link between cardiovascular risk factors and Covid-19 severity. However, these studies could not ascertain the cause and effect relationship due to the observational design.

The new study, published in the science journal Frontiers in Genetics, used a novel approach called ‘Mendelian Randomisation’, which leveraged the individual genetic information, to investigate the effects of cardiovascular risk factors on the risk of Covid-19 infection.

Lead author Dr Nay Aung from the Queen Mary University of London said: “Our results show that individuals with high body mass index (BMI), a marker of obesity, and high low-density lipoprotein (LDL) cholesterol (also known as ‘bad’ cholesterol) are at an increased risk of getting Covid-19. Other cardiovascular risk factors (high blood pressure and diabetes) do not appear to elevate the Covid-19 risk.

“Our findings support the use of BMI and LDL cholesterol as important metrics alongside other known characteristics (such as age and ethnicity) in the risk assessment of vulnerability to Covid-19 infection,” added Aung.

The findings may have an impact on public health policy, whereby those who fall in the at-risk obese category or those with extreme hyperlipidemia in the general population may require more rigorous social distancing or shielding.

Furthermore, studies assessing the role of cholesterol modification therapy during illness or hospital admission could be undertaken to assess the potential impact on outcomes.: https://www.hindustantimes.com/healt...OiykXlGsN.html

• Coronavirus Cases: 58,337,219

Deaths: 1,384,343

Underreported US death count: 261,297

American Civil War Casualties (North and South) - 214,938

it's been blown way out of proportion.

[S Landreth]

• Pfizer Covid Vaccine Faces Hurdles After FDA Filing Friday

Pfizer Inc. and BioNTech SE requested emergency authorization of their Covid vaccine on Friday, and it could take at least three weeks for a U.S. Food and Drug Administration decision as trial data is probed by agency staff and outside advisers.

Shown to be 95% effective and without any major safety issues, their vaccine could be the first to be cleared for use, but first it must undergo a thorough vetting. The filing could enable its use by the middle to the end of December, the companies said in a statement.

A key step along the way is a meeting of outside FDA advisers, all experts in infectious diseases and vaccines. The FDA will convene the advisory group Dec. 10 to discuss Pfizer and BioNTech’s vaccine, according to a statement from the agency Friday. The FDA will spend the few short weeks between the emergency authorization request and the meeting sorting through the trial data.

“I don’t find that time frame to be unreasonable in light of the amount of data the agency needs to analyze and in order to ensure full participation by all stakeholders in the advisory committee,” said John Taylor, who served as counselor to the head of the FDA during the Obama administration and now works as a consultant at Greenleaf Health. “It ensures that the agency can conduct a well run, well attended advisory committee in order to ensure maximum transparency, which I think will be an important factor in patients’ willingness to take the vaccine.”

FDA Commissioner Stephen Hahn also said earlier this week the agency will post documents related to its review of any vaccine granted an emergency authorization. The aim is to “contribute to the public’s confidence in the agency’s rigorous review of scientific data and the appropriate use of authorized products.”

Key Moments

The emergency authorization process allows drugs and vaccines targeting Covid-19 to reach Americans much faster than through standard approval channels. The FDA review process normally takes about six to 10 months, depending on the candidate’s priority status. Some treatments, such as certain cancer drugs, are cleared in just a couple of months.

Pfizer and federal and state government officials have been preparing to help distribute the vaccine within days of an FDA emergency authorization. The company’s vaccine will require special freezers to transport and store.

There are two key moments to watch for during an FDA advisory panel meeting. The first comes two days before the advisers meet, when the FDA typically releases its staff report on the clinical trial data. This will offer some insight into whether the agency is leaning toward authorizing the vaccine. The second is at the end of the meeting, when it will take a non-binding vote on whether FDA should clear the shot for public use.

The FDA staff will be combing through Pfizer’s raw data, which the public doesn’t have access to, rather than relying on the company’s own results to determine the safety and efficacy of the vaccine. The agency and Pfizer will each summarize their findings for the advisory panel.

Moderna Inc. has also released positive interim results from a final-stage trial and said it’s close to seeking emergency authorization of its Covid-19 vaccine. The company has said it expects final results from the study in about a week or two.

Should the FDA grant emergency authorization shortly after the meeting, there are some steps the agency would normally take for a vaccine, but may be skipped in this case. Under the regular vaccine approval process, the FDA would collect the results of a company’s quality testing as well as samples that the agency could test itself to ensure they meet U.S. standards before doses are released to the public.

Since early Covid-19 vaccines will not go through the regular approval process but rather be authorized on an emergency basis, the FDA can forgo collecting the data and samples. The agency will make the decision on a case-by-case basis, a spokeswoman said.

The FDA has also said emergency use regulations don’t require them to conduct inspections of manufacturing plants ahead of a vaccine authorization as they normally would with regular approval. The inspections serve as a check that manufacturers of drugs or vaccines can make quality products.

Founded in 2010, Moderna has yet to gain FDA clearance of any product. An FDA database doesn’t list Moderna as ever having been inspected by the agency.

The FDA isn’t the only U.S. agency that needs to consider the vaccines. Another group of advisers for the Centers for Disease Control and Prevention also must meet on the vaccine and make recommendations as to who should be first in line to get it. The timing of this meeting is unclear.

Arkansas Health Secretary Jose Romero, who chairs the CDC’s Advisory Committee on Immunization Practices, said in an email through a spokeswoman Wednesday that the panel maintains a plan to meet shortly after FDA grants emergency authorization for a Covid-19 vaccine. Health and Human Services Secretary Alex Azar also said Wednesday there is an effort to move the CDC advisory meeting up to coincide with that of the FDA advisers. Azar’s office did not respond to requests for comment.

Health Workers First

It’s expected health-care workers will be the first to receive a vaccine. Between Pfizer and Moderna, Azar said, the U.S. should have access to about 40 million doses by the end of December, enough for 20 million people to get the two-dose regimen.

CDC estimates there are 17 million to 20 million health-care workers in the U.S., according to a presentation Kathleen Dooling, an epidemiologist with the agency, gave to ACIP in August.

As the vaccine doses start rolling out, the government’s involvement won’t end there. The FDA has said it expects manufacturers to apply for regular approval as soon as possible. This will require pharmaceutical companies to continue their studies, even after they apply for emergency authorization.

The agency is allowing them to gain initial clearance based on two months of safety data; six months of data is expected in an application for a full approval, Doran Fink, deputy director of the FDA’s clinical division of vaccines and related products applications, told agency advisers at a meeting in October.

Once Americans start taking a vaccine, it’s expected to become difficult for pharmaceutical companies to keep running trials that include a group of volunteers who get a placebo instead of the vaccine. The FDA is currently considering alternatives, Fink said.: https://www.bloomberg.com/news/artic...rdles-to-clear

• Coronavirus Cases: 58,616,973

Deaths: 1,388,786

Underreported US death count: 261,790

American Civil War Casualties (North and South) - 214,938

it's been blown way out of proportion.

[S Landreth]

• EU to have six vaccine contracts within days, France says

AstraZeneca-Oxford vaccine can 'get us back to normal', says Pangalos

The Covid-19 vaccine developed by Oxford university and AstraZeneca is “clearly effective” in reducing infections and transmission while lowering the chances of people becoming ill, says an executive vice-president at the Cambridge-based pharmaceuticals group.

"It’s got every chance of being a very successful, very effective vaccine that can get us back to normal,” said Mene Pangalos, executive vice-president at AstraZeneca's biopharmaceuticals research and development unit at AstraZeneca.

“What I’m very confident about is that people are not getting sick with this vaccine, which means that, ultimately even if you were to get ill, you’ll have mild symptoms,” Sir Mene told BBC Radio 4's Today programme after the news broke on Monday that the vaccine has exceeded regulatory requirements for effectiveness in phase 3 trials.

"That’s incredibly important because it will keep hospital beds free and people won’t be dying from this virus.”

Dosing regimens gave different results, with one producing efficacy of 90 per cent and the other 62 per cent. The average efficacy was 70 per cent.

Two other vaccines, developed by Pfizer and BioNTech and the other by Moderna, have shown to be more than 90 per cent effective.

Shares in AstraZeneca slipped 2 per cent on Monday and are up about 7 per cent this year.

• Coronavirus Cases: 59,060,168

Deaths: 1,394,833

Underreported US death count: 262,701

American Civil War Casualties (North and South) - 214,938

it's been blown way out of proportion.

[S Landreth]

Thailand - State of emergency extended to Jan 15

The cabinet has approved a 45-day extension of the state of emergency for the eighth time to mid-January.

The approval was a formality after a meeting of the Centre for Covid-19 Situation Administration, chaired by Prime Minister Prayut Chan-o-cha, had approved it on Nov 18 and submitted the proposal to the cabinet for final approval.

The latest extension is from Dec 1 this year to Jan 15 next year, according to Anucha Burapachaisri.

He said the extension was longer than the previous 30-day periods so it covered the New Year holidays where many people travel and the risk of an outbreak was high.

Taweesilp Visanuyothin, spokesman of the centre, said last week that apart from the need to keep the situation under control during the holidays, the BWF World Tour badminton event would be held during the period where several foreign athletes would join.: https://www.bangkokpost.com/thailand...nded-to-jan-15

Perhaps a blessing in disguise for the Golden Land.

[S Landreth]

Thailand - Tourism prospects opaque

The tourism sector may have to wait until 2022 to see "normal" revenue, described as 80% of the pre-pandemic level, as major markets are reluctant to ease travel measures unless there is distribution of a successful vaccine, says the Tourism Authority of Thailand (TAT).

TAT governor Yuthasak Supasorn said prospects in 2021 remain opaque as there are many unpredictable factors, particularly as infections ravage many countries, meaning even more stringent travel restrictions.

The World Tourism Organization predicted a rebound in international tourism is likely by the third quarter of 2021 or in 2022, and the TAT has a similar outlook after hearing from the main target nations of Thai tourism that they will encourage domestic tourism instead.

Mass outbound trips are not likely to happen before their populations get vaccinated.

He said the meeting between Yang Xin, charge d'affaires at the Chinese embassy, and Tourism and Sports Minister Phiphat Ratchakitprakarn this week offered a clue to the tourism outlook next year.

Visitors from China, who made up roughly 10 million, or 25% of the foreign arrivals in 2019, are unlikely to travel en masse to Thailand as long as there's no proven track record of a vaccine.

Thailand may start to see a moderate number of international guests in the second or third quarter next year from long-haul markets as summer approaches, which some consider a lower-risk season for virus spread, said Mr Yuthasak.

He said although there is good news about vaccine development, it may take all of next year to produce, distribute globally and more importantly, revive people's confidence in travelling.

"We set 2021 as a year of adjustment before seeing a leap in 2022. We forecast Thailand will achieve 2.5 trillion baht in tourism revenue in 2022, or 80-90% of 2019, which recorded 3 trillion baht," said Mr Yuthasak.

The challenge for Thai tourism is to push average spending per trip to 50,000-60,000 baht after the pandemic eases, the same level as before the outbreak, he said.

Mr Yuthasak said international tourism will likely need two years to recover, including outbound Thai travel.

"There will be more pent-up demand by 2022, but in the early stages we have to accept the volume will not be as high as before the pandemic," he said. Thailand should largely depend on domestic tourism next year, said Mr Yuthasak.

The government is considering extending a stimulus package for local travellers. The "We travel together" campaign, which subsidises 40% of hotel expenditure and airfares, is likely to be extended to Songkran in April.

There are 1.15 million room nights available for redemption from the 5 million granted for this scheme.

The TAT expects the allotment will be fully used within this year, one month earlier than its deadline on Jan 31.: https://www.bangkokpost.com/business...ospects-opaque

Perhaps a blessing in disguise for the Golden Land.

[S Landreth]

Thailand signs deal with AstraZeneca for Covid vaccine

Thailand has signed an advance agreement with AstraZeneca to secure a supply of its Covid-19 vaccine and for local production with technology from the British-Swedish firm.

The agreement comes amid reports that AstraZeneca is preparing to conduct new global trials, after critics questioned aspects of an earlier trial that produced results showing up to 90% efficacy of the vaccine. However, CEO Pascal Soriot said he didn’t expect the additional trial to hold up regulatory approvals in the UK and European Union.

In addition to supplying the vaccine to Thailand, AstraZeneca will also support the local mass production of the doses by Siam Bioscience.

The number of doses to be supplied to Thailand was not disclosed. But Prime Minister Prayut Chan-o-cha said on Thursday that the contract was for the purchase of 26 million doses, enough for 13 million people, as each person needs two shots.

The multinational pharmaceutical manufacturer on Friday also signed a deal with the Philippines for 2.6 million shots of the vaccine. Malaysia, meanwhile, announced an agreement with Pfizer Inc to obtain enough of its Covid-19 vaccine to vaccinate 6.4 million people.

Opas Kankawinphong, the director-general of the Disease Control Department, and National Vaccine Institute director Nakorn Premsri represented Thailand in signing the deal with James Teak, president of AstraZeneca Thailand, at Government House.

Gen Prayut, who presided over the ceremony, expects the vaccine will be available next year and the government will be ready to give all people access to it, government spokesman Anucha Buranachaisri said on Friday.

The government has prepared a research and development fund for Thailand to produce the Oxford University-developed research vaccine locally in the fight against the coronavirus, the prime minister added.

AstraZeneca is currently in the last stage of vaccine trials before seeking final regulatory approvals for broad distribution of the long-awaited vaccine to end the outbreak of the virus that has crippled the global economy.

Siam Bioscience is a leading local pharma company involved in research and development of medicines, medical equipment and healthcare products. ACM Sathitphong Sukwimol, the company chairman, also witnessed the ceremony.

Thailand has been one of the most successful in containing the spread of the virus, with just 60 fatalities and 3,961 total confirmed infections as of Friday.

Mr Soriot, who joined the event via teleconference, praised Thailand for keeping the virus under control. He said the country’s vaccine production capacity in the future would also give other Southeast Asian countries access to the vaccine.: https://www.bangkokpost.com/thailand...-covid-vaccine

Perhaps a blessing in disguise for the Golden Land.

[S Landreth]

• New Zealand study details COVID-19 spread on long-haul flight despite tests

A recent case study details COVID-19 transmission on a New Zealand long-haul flight, even with negative pre-departure testing results and social distancing requirements.

The 12-page report, released by New Zealand health officials last week Friday, follows a cluster of coronavirus cases linked to one passenger traveling on an 18-hour flight from Dubai to New Zealand in September. Though the traveler tested negative with a PCR test before the flight, researchers concluded that "at least four in-flight transmission events of SARS-CoV-2 likely took place" as the pre-symptomatic yet contagious person infected at least four others. SARS-CoV-2 is the virus that causes COVID-19.

"By combining information on disease progression, travel dynamics and genomic analysis, we conclude that at least four in-flight transmission events of SARS-CoV-2 likely took place," the report, funded in part by the New Zealand Ministry of Health, Ministry of Business, Innovation and Employment, says.

The close tracking of post-flight COVID-19 cases in this study was made possiblehanks to New Zealand's quarantine program, which requires people returning to the country to undergo managed isolation, quarantine and testing.

Out of the 86 total passengers, seven who arrived in New Zealand on the Sept. 29 flight tested positive despite "reported use of masks and gloves in-flight." They were seated within four rows of each other, and it was found that the virus' genetic sequence in six out of seven positive passengers was identical, with the exception of a single mutation in one case.

This study raises concerns about the safety of long-haul flights amid the pandemic, as in-flight transmissions occurred despite the enforcement of pre-departure tests, social distancing and and personal protective equipment, though at least one person who tested positive reported taking their mask off when sleeping and when seated.

Other recent studies have also detailed the risks of air travel during the pandemic. A report from Irish public health officials published in the journal of the European Centre for Disease Prevention and Control in late October said 13 of 49 passengers on a 7½-hour flight to Dublin tested positive for COVID-19, and another 46 in contact with them in Ireland became infected. Four were hospitalized, one in the ICU.

"This outbreak demonstrates the potential for spread of SARS-CoV-2 linked to air travel,'' the report says, while noting that researchers don't know whether the affected passengers were infected in-flight, during a connection, or before the flight.

However, other studies, such as a 187-page study by Harvard scientists released that same month, concluded otherwise, reporting that air travel "is as safe as or substantially safer than the routine activities people undertake during these times," partially due to the ventilation systems on planes that refresh the air every two to three minutes as well as heavy-duty disinfecting, strict face mask enforcement and social distancing during boarding and deplaning.

Though the Centers for Disease Control and Prevention discouraged traveling for Thanksgiving on Thursday, the Transportation Security Administration reported that more than 1 million air travelers still passed through security checkpoints at U.S. airports Friday and Sunday.: https://www.usatoday.com/story/trave...ht/6388833002/

• Coronavirus Cases: 59,462,349

Deaths: 1,401,257

Underreported US death count: 263,536

American Civil War Casualties (North and South) - 214,938

it's been blown way out of proportion.

[S Landreth]

AstraZeneca CEO: "We need to do an additional study" on COVID vaccine

AstraZeneca CEO Pascal Soriot said on Thursday the company is likely to start a new global trial to measure how effective its coronavirus vaccine is, Bloomberg reports.
Why it matters: Following Phase 3 trials, Oxford and AstraZeneca said their vaccine was 90% effective in people who got a half dose followed by a full dose, and 62% effective in people who got two full doses.

• “Now that we’ve found what looks like a better efficacy we have to validate this, so we need to do an additional study,” Soriot said, in his first interview since the University of Oxford announced data this week from the vaccine it's developing with AstraZeneca.

Soriot told Bloomberg that it would likely be another “international study, but this one could be faster because we know the efficacy is high so we need a smaller number of patients.”

• Soriot does not expect the trial to affect regulatory approvals in the European Union and the U.K., although FDA clearance may take longer, he said.

https://www.axios.com/coronavirus-as...8ccf6f4b3.html

• Coronavirus Cases: 61,450,624

Deaths: 1,440,622

Underreported US death count: 269,597

American Civil War Casualties (North and South) - 214,938

it's been blown way out of proportion.