Category: Corona Virus

Sign up for The Brief, our daily newsletter that keeps readers up to speed on the most essential Texas news.

Jobless Texans who refuse work offers because they feel like the job isnt safe during the pandemic wont be able to receive unemployment benefits as of June 26, the Texas Workforce Commission announced this week.

Since last year, special pandemic guidelines have allowed some out-of-work people to decline a job if it doesnt have proper COVID-19 health or safety protocols and still qualify for unemployment benefits.

The decline in COVID cases in Texas, widespread availability of vaccines, and greater availability of services such as child care renders such guidance out of date, a TWC press release stated Tuesday.

James Bernsen, spokesperson for the TWC, said that the reversal of the guidelines is associated with the removal of COVID federal unemployment aid that Gov. Greg Abbott announced last month.

Starting June 26, jobless Texans will lose access to a $300-per-week supplemental benefit through the Federal Pandemic Unemployment Compensation program. In addition, Abbott cut off a lifeline called Pandemic Unemployment Assistance, which extends unemployment aid to gig workers, self-employed people and others who dont traditionally receive unemployment benefits.

As of April 30, approximately 344,000 Texans were receiving these PUA benefits, according to data compiled by economist Julia Coronado, economics professor at the University of Texas at Austin. President Joe Biden signed an executive order in January clarifying that the PUA program extends to those who refuse a job because of COVID safety concerns.

Congress had extended these programs through September, but Abbott withdrew Texas from them months early, following pressure from business groups who said the programs disincentivized work. According to a press release, Abbotts office said the decision was made to focus on connecting unemployed Texans with jobs instead of paying them unemployment benefits.

Bernsen said that the pandemic guidelines that allow jobless people to refuse work for COVID-19 safety reasons and still qualify for any state or federal unemployment benefits are associated with the COVID-related unemployment that the state withdraws from on June 26.

The COVID-related programs are ending, so were ending the COVID-related exceptions, he said.

TWC did not immediately release the number of people who have been turning down jobs for COVID-19 safety reasons and would be impacted by this change. Bernsen pointed out that unemployment claims have been declining and vaccination rates increasing in recent months.

The number this would apply to is continually decreasing, he said. We're not in the height of the pandemic, which is what [the guidelines] were designed for.

Rick Levy, president of the Texas AFL-CIO, said the changes are cruel and exhibit the states characteristic lack of understanding towards working people and their needs.

This pandemic is not over, he said. To say, 'Well, we're heading in the right direction, so we're going to eliminate doing all the things that have us heading in the right direction,' is just really short sighted.

Disclosure: University of Texas at Austin has been a financial supporter of The Texas Tribune, a nonprofit, nonpartisan news organization that is funded in part by donations from members, foundations and corporate sponsors. Financial supporters play no role in the Tribune's journalism. Find a complete list of them here.

Go here to read the rest:

Texas unemployment benefits no longer have COVID-19 fear exemption - The Texas Tribune

How do regulatory authorities evaluate COVID-19 vaccines?

Regulators rigorously evaluate scientific and clinical evidence provided by vaccine manufacturers. Vaccine manufactures are legally obliged to follow defined standards in the data they provide, and their clinical research and manufacturing operations are subject to regulatory oversight. Either full or summary data from clinical trials is made available following vaccine evaluation. Each vaccine is thoroughly assessed for safety, efficacy and pharmaceutical quality to determine whether it can be approved for use. Regulators use available scientific evidence from preclinical laboratory research, human clinical trials, and manufacturing information to assess benefits and risks of candidate vaccines.

Regulators may seek additional expert advice from independent scientific advisory committees to help inform their decision on whether to approve a vaccine. These committees are made up of experts in science, medicine (including infectious diseases) and public health, and often include consumer and healthcare professional representatives.

Public health agencies have a different role than regulatory authorities. They develop and deliver vaccination programmes, often working with their expert immunisation technical advisory committees. This includes prioritising and designating populations for vaccination with specific vaccines, issuing additional recommendations and providing information more broadly about vaccines and immunization. They also collaborate with regulators to monitor the safety of vaccines after they are approved for use.

Globally, the public can have confidence in the rigour of the process used to scientifically evaluate the safety, efficacy and quality of vaccines before they are approved for use in the wider population.

Safety evidence prior to potential regulatory authorisation:

Safety evidence is an essential part of each regulatory submission for a COVID-19 vaccine. It is gathered during all phases of the vaccine development process. Robust assessment of safety is carried out in the clinical trials and submitted to regulators for review as part of the approval process.

All adverse events need to be examined and reported in the regulatory submission by the companies for a marketing licence. Typically, regulators will require that participants in clinical trials have been followed for at least 1-2 months after receiving their final vaccine dose. Generally, based on previous experience with vaccines, most adverse events occur within such timeframes, though rare adverse events might not be recognised until after wide population use. There will also be longer-term (for example for 6-12 months or more) follow-up of those who participated in the earlier phases of the clinical trials of each vaccine. Many trial participants will also be followed for at least one year to assess the duration of protection and longer-term safety of individual vaccines, and safety data from these longer-term trials will be carefully reviewed by regulators as part of post-approval monitoring of safety.

Efficacy:

Apart from information on the types of immune responses induced by the vaccine, companies must submit data from well-designed clinical trials to regulators to demonstrate that the vaccine prevents COVID-19. The data showed there were sufficient numbers of people included in the clinical trials receiving the vaccine so that the efficacy of the vaccine can be accurately measured (generally at least 10 000 and usually 15 000 or more people who receive the vaccine, in addition to those in the control arm). Populations in clinical trials should include a range of age groups and people with co-morbidities. Given the disproportionate impact of COVID-19 on older people, COVID-19 vaccine clinical trials have included significant numbers of older participants.

Vaccine clinical trials for a new candidate vaccine showed that vaccines very significantly reduced COVID-19 in people who were vaccinated, compared to a control group of people who did not receive the vaccine, through a reduction in numbers of laboratory confirmed SARS-CoV-2 infections.

Quality:

Any COVID-19 vaccine that receives regulatory authorisation must be manufactured according to internationally accepted stringent regulatory standards of good manufacturing practices (GMP). Regulators review data to confirm that the manufacturing process at each production site is well-controlled and consistent. This will include data on the composition and purity of the vaccine and its potency, as well as data on every step of manufacturing and on the controls used to ensure that each batch of vaccine is consistently of a high quality. Data on vaccine stability must also be provided before a vaccine can be approved. After approval, batches may also undergo evaluation by individual national regulatory authorities to ensure they meet national requirements, before they can be supplied.

Monitoring safety and effectiveness after vaccine approval:

After a vaccine is approved for use, regulators conduct robust effectiveness monitoring as well as monitoring of safety and risk minimisation activities (pharmacovigilance). They need to continuously monitor vaccine safety to ensure that the benefits of the vaccine continue to outweigh the risks. Regulators do this by:

It is very important that healthcare professionals not only diligently report any adverse events they see in their patients, but also encourage people who are vaccinated to immediately report adverse events to their healthcare professionals or to the medicines regulator in countries where direct reports from members of the public are accepted by the regulator. Reporting all relevant events helps regulators assess the possible role of the vaccine in causing the adverse event and assists in identifying safety issues relating to newly introduced vaccines.

As part of the safety monitoring and review of all suspected side effects reporting for vaccines, regulators have developed lists of Adverse Events of Special Interest. These lists include some events that have been associated with other vaccines (for example anaphylaxis). Others are included on these lists because they are serious events that are important to monitor extremely closely, even though there is no evidence that they are causally associated with specific vaccines. Having information on the background rates of these events that would be expected in people who have not received a vaccine will help ensure that any increased reporting of these events can be quickly detected and thoroughly investigated by regulators.

The widespread use of COVID-19 vaccines, including in the elderly and in patients with underlying health conditions, will unfortunately mean that there will be deaths and serious illnesses that are purely coincidental and unrelated to vaccinations. The job of each regulator, together with the relevant medical experts and vaccine manufacturers is to determine causality. There will be a special focus on monitoring safety in some groups of people, such as pregnant women, persons with severe pre-existing illness, older people, children, and in people also receiving vaccines for prevention of other diseases.

Regulators, often in collaboration with public health authorities, are able to take decisive action if a safety issue is identified.These actions might include: issuing safety communications for patients, healthcare professionals and the community; updating the product information or consumer information for the vaccine; preventing the release of a particular batch of vaccine; and, taking other regulatory actions such as restriction of vaccine authorisation to a particular subgroup of the community or revocation of authorisation.

Commonly reported adverse events

The most commonly-reported events with COVID-19 vaccines are expected vaccine side effects, such as headache, fatigue, muscle and joint pain, fever and chills and pain at the site of injection. The occurrence of these adverse events is consistent with what is already known about the vaccines from clinical trials.

Regulators approve and maintain an approval of a vaccine only if they determine that the known and potential benefits of the vaccine outweigh its known and potential risks.

Anaphylaxis is a very rare side effect that may occur with any vaccine. There have been some other reported adverse events which include facial weakness, seizures, loss of sense of taste or small and cardiac events, but none are confirmed to be causally related to the vaccines.

mRNA vaccines

The major adverse event of special interest reported for these vaccines, which include the Pfizer and Moderna vaccines is anaphylaxis. Regulators carefully review the reports of possible anaphylaxis to determine whether they are consistent with true anaphylaxis and whether they may have been caused by the vaccine. Anaphylaxis reports remains very rare (in the order of 10 cases per million vaccinated).

Guidance on the management of possible anaphylaxis is included in the Product Information/Label for these vaccines. Routine vaccination procedures include keeping people under observation for at least 15 minutes after vaccination and having appropriate medical treatment on hand so that anaphylaxis can be rapidly managed. These vaccines should not be given to people with a known history of a severe allergic reaction to any of the vaccine components. A second dose of mRNA vaccine should not be given to those who have experienced anaphylaxis to the first dose.

There have been some other reported adverse events, which include unusual bleeding and blood clotting disorders, facial weakness, seizures, loss of sense of taste or smell and cardiac events. Regulators monitor and carefully review if there is a causal relationship between the vaccines with those adverse events, and, if appropriate, they will be included in Product Information / Product Label of vaccines of concern.

Adenovirus vector vaccines

These include the AstraZeneca, Janssen, Gamaleya and CanSino Biologics vaccines. Internationally, the AstraZeneca and Janssen COVID-19 vaccines have been associated with a very rare and unusual clotting syndrome involving thromboembolic events (blood clots) with thrombocytopenia (low blood platelet count). This condition has been termed Thrombosis with Thrombocytopenia Syndrome (TTS). Medicines regulators are meeting regularly to share information about cases to better characterise this risk and understand this syndrome. Less information is available internationally about adverse events following the Gamaleya and CanSino Biologics vaccines.

The overall number of reports received of blood clots in the veins or arteries (including venous thrombosis or venous thromboembolism) occurring without thrombocytopenia is no higher than the expected background population rate for the more common type of blood clots in most countries.

The spontaneous reporting rates of thromboembolic events with thrombocytopenia vary by country and the precise incidences are difficult to estimate, but for the AstraZeneca vaccine, based on substantial use in Europe and the UK, the frequency of such events is very rare. Available estimates are of the order of 10-15 per million people vaccinated (note that for some countries this statistic is based on the numbers of reports of suspected cases of TTS rather than numbers of confirmed cases). Thromboembolic events with thrombocytopenia have also been reported in the United States for the Janssen vaccine, at a rate of about 2-3 per million doses administered. National regulators are continuing to monitor the issue closely and to publish up to date information on the numbers of cases reported and the latest estimates of the incidence.

The cases of thromboembolic events with thrombocytopenia after vaccination were mainly reported for younger rather than older individuals. This, together with the risk of serious illness or death associated with COVID-19 being much higher in middle-aged and older people, has led public health authorities in some countries to recommend that vaccination with the Astra Zeneca vaccine not be initiated in younger individuals.

Healthcare professionals should be alert to the signs and symptoms of thromboembolism and thrombocytopenia as well as coagulopathies after vaccination as TTS requires specific management. Vaccinated individuals should be instructed to seek immediate medical attention if they develop symptoms such as a severe or persistent headache, blurred vision, shortness of breath, chest pain, leg swelling, persistent abdominal pain or unusual skin bruising and/or petechiae (tiny purple, red, or brown spots on the skin) mostly occurring within around 4-20 days after vaccination, although some cases have been reported later than 20 days post vaccination. This information is in the Product Information / Product Label of the vaccines as approved by regulators.

Q: How have the vaccines been developed so quickly? Does this mean that their safety and efficacy has been compromised?

A: The speed of development of COVID-19 vaccines has been unprecedented for several reasons, but the safety and efficacy requirements for vaccines have not been compromised, Vaccine development was facilitated by:

Q: Will mRNA vaccines affect the DNA of vaccine recipients?

A: No. The mRNA in the vaccine has not been shown to incorporate itself into the genes of vaccine recipients and breaks down in the weeks after vaccination. mRNA vaccines contain genetic instructions for our cells, which only read them and provide copies of the SARS-CoV2 spike protein. This enables the bodys natural immune systems to cause a response in vaccine recipients if they are later exposed to the virus.

Q: How long will COVID-19 vaccination provide protection for immunised people?

A: We do not yet know how long protection from any of these vaccines lasts. We will get better insights over the next 12 months.

Q: Why are there so many vaccine candidates?

A: As the global seriousness of the pandemic became rapidly apparent, development of effective vaccines for COVID-19 became the top priority of many pharmaceutical companies and medical research institutes. There was also unprecedented government and private sector investment in vaccine development. There is now a wide range of technologies for developing new vaccines - and many of the organisations developing COVID-19 vaccines have particular experience in one or more of these technologies. This has ensured that there would still be vaccines available if some were not approved for reasons of efficacy, safety or manufacturing challenges.

Q: What if many people start getting a reaction from a particular COVID-19 vaccine?

A: Short-term reactions, such as soreness at the injection site, fatigue or headache are common following any vaccination with COVID-19 vaccines. These reactions usually pass in a day or two. If new evidence becomes available that suggests that a specific serious adverse event may be linked to a particular COVID-19 vaccine then regulators will take action, working collaboratively on a global basis and liaise with public health authorities. The type of actions that can be taken depend on the nature of the adverse event, and could range from issuing safety warnings for patients, healthcare professionals and the community; updating the product information or consumer information for the vaccine to show contraindications for the use in particular patients (e.g. those with certain co-morbidities); to closely monitoring adverse events in certain groups of patients; preventing the release of a particular batch of vaccine through to temporary suspension of the use of the vaccine until more is known.

Q: How are regulators speeding up the time it takes to authorise a COVID-19 vaccine?

A: Many regulators globally have implemented faster access pathways for COVID-19 vaccines, without compromising on strict standards of safety, quality and efficacy.

Q: Did our country approve this COVID-19 vaccine, or are we relying on another countrys approval?

A: Most countries are carrying out independent regulatory evaluations on the submitted data for each vaccine. However, to ensure a more efficient use of resources and expertise, regulators in different countries are communicating closely on safety, efficacy and quality data and discussing technical issues as they may arise. In many cases principles of WHO Good Reliance Practices and collaborative mechanisms leverage the output of other regulators.

Q: Why werent very rare blood clots with low platelets with the AstraZeneca or Janssen vaccines picked up during clinical trials?

A: Thromboembolic events with concurrent thrombocytopenia are very rare with estimates based on the number of spontaneous reports suggesting an overall incidence on the order of 10-15 cases per million doses. The clinical trials of these vaccines included large numbers of people, often with 10,000 to 20,000 individuals in the active vaccine arms, but even in trials of this size it was statistically unlikely that such very rare events would be detected. This shows the importance of continual safety monitoring during the use of these vaccines, to allow very rare events to be detected and investigated further.

-------------------------------------------------------------------------------

About ICMRA

ICMRA brings together the heads of 30 medicines regulatory authorities* from every region in the world, with the WHO as an observer. Medicines regulators recognise their role in facilitating access to safe and effective high-quality medicinal products essential to human health and well-being. This includes ensuring that benefits of vaccines outweigh their risks.

ICMRA is an international executive-level coalition of key regulators from every region in the world. It provides a global strategic focus for medicines regulators and gives strategic leadership on shared regulatory issues and challenges. Priorities include coordinated response to crisis situations.

Members of ICMRA include: Therapeutic Goods Administration (TGA), Australia; National Health Surveillance (ANVISA), Brazil; Health Products and Food Branch, Health Canada (HPFB-HC), Canada; China National Medical Products Administration (NMPA), China; European Medicines Agency (EMA) and European Commission - Directorate General for Health and Food Safety (DG - SANTE), European Union; French National Agency for Medicines and Health Products Safety (ANSM), France; Paul-Ehrlich-Institute (PEI), Germany; Health Product Regulatory Authority (HPRA), Ireland; Italian Medicines Agency (AIFA), Italy; Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), Japan; Ministry of Food and Drug Safety (MFDS), Korea; Federal Commission for the Protection against Sanitary Risks (COFEPRIS), Mexico; Medicines Evaluation Board (MEB), Netherlands; Medsafe, Clinical Leadership, Protection & Regulation, Ministry of Health, New Zealand; National Agency for Food Drug Administration and Control (NAFDAC), Nigeria; Health Sciences Authority (HSA) Singapore; Medicines Control Council (MCC), South Africa; Medical Products Agency, Sweden; Swissmedic, Switzerland; Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom; Food and Drug Administration (FDA), United States.

Associate members include: Argentina national Administration of Drugs, Foods and Medical Devices (ANMAT); Austrian Medicines and Medical Devices Agency (AGES), Colombia National Food and Drug Surveillance Institute (INVIMA); Cuba Center for State Control of Medicines, Equipment and Medical Devices (CECMED); Danish Medicines Agency (DKMA); Israel Ministry of Health (MOH); Poland Office of Registration of Medicinal Products and Biocidal Products (URPLWMiPB); Portugal National Authority of Medicines and Health Products (INFARMED); Russia Federal Service for Surveillance in Healthcare (Roszdravnadzor); Saudi Food and Drug Authority (SFDA); Spanish Agency of Medicines and Medical Devices (AEMPS).

About the World Health Organization

The World Health Organization provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States, across six regions and from 149 offices, to promote health, keep the world safe and serve the vulnerable. Our goal for 2019-2023 is to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and provide a further billion people with better health and wellbeing.

Read the original:

Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness - World Health Organization

COLUMBUS (WCMH) The Ohio Department of Health has releasedthe latest number of COVID-19 casesin the state.

As of Friday, June 11, the ODH reported a total of 1,106,411 (+347) cases since the pandemic began, leading to 59,836 (+59) hospitalizations and 8,209 (+8) ICU admissions. A total of 5,434,851 people or 46.5% of the states population has started the vaccination process, an increase of 12,313 from the previous day.

The ODH also reported 70 deaths Friday, bringing the state total to 20,091. The state is updating the total number of deaths only after death certificates have been processed, usually twice a week.

On Thursday, Gov. Mike DeWinespoke to the latestwinners of theVax-a-milliondrawings and provided updates on the pandemic. The third set of winners wasMark Cline of Richwoodas the $1 million prize adult winner andSara Afaneh of Sheffield Lakeas the student scholarship winner.

DeWine said there were 3.3 million adult entries and 144,000 student entries for the drawing, an increase of 136,000 adult and 11,000 student entries. To be eligible, a person must have received at least one dose of COVID-19 vaccine and then register by visitingohiovaxamillion.comor calling the Department of Health at 833-4-ASK-ODH.

Two drawings remain, with entries closing the Sunday before the winners are announced on Wednesday.

DeWine said the state had a rate of 39.1 cases per 100,000 people for the two weeks ending Tuesday and that all but 16 of 88 counties were below 50 cases per 100,000 people.

That was the mark DeWine set in the spring for dropping his pandemic health orders before instead of allowingmost of them to end on June 2, possibly in response to the General Assemblyoverriding his veto on a billthat would allow them to end those orders on their own.

Every county is now below 100 cases per 100,000 people, which is the threshold for being considered high incidence by the CDC. The highest rate in the state is Lawrence County at 77.4 cases per 100,000 people. Four counties have even dropped into the single digits: Putnam, Hancock, Vinton and Coschocton.

Continued here:

Coronavirus in Ohio Friday update: Latest number of cases to be released at 2pm - WKBN.com

Another Mainer has died as health officials on Friday reported 38 more coronavirus cases across the state.

The number of coronavirus cases diagnosed in the past 14 days statewide is 943. This is an estimation of the current number of active cases in the state, as the Maine CDC is no longer tracking recoveries for all patients. Thats up from 1,033 on Thursday.

Its the eighth straight day when Maine saw new coronavirus cases slip below the triple digits, a level of transmission that seemed unthinkable this past winter when infections surged well over 800 a day at times.

A man in his 50s from York County has succumbed to the virus, bringing the statewide death toll to 844.

Fridays report brings the total number of coronavirus cases in Maine to 68,487, according to the Maine CDC. Thats up from 68,449 on Thursday.

Of those, 50,106 have been confirmed positive, while 18,381 were classified as probable cases, the Maine CDC reported.

The new case rate statewide Friday was 0.28 cases per 10,000 residents, and the total case rate statewide was 511.71.

Maines seven-day average for new coronavirus cases is 62, down from 66.9 a day ago, down from 73.6 a week ago and down from 276.7 a month ago. That average peaked on Jan. 14 at 625.3.

The most cases have been detected in Mainers younger than 20, while Mainers over 80 years old make up the majority of deaths. More cases and deaths have been recorded in women than men. For a complete breakdown of the age and sex demographics of cases, hospitalizations and deaths, use the interactive graphic below.

So far, 2,045 Mainers have been hospitalized at some point with COVID-19, the illness caused by the new coronavirus. Of those, 45 are currently hospitalized with 24 in critical care and 14 on a ventilator. Overall, 89 out of 379 critical care beds and 227 out of 319 ventilators are available. Meanwhile, 451 alternative ventilators are available.

The total statewide hospitalization rate on Friday was 15.28 patients per 10,000 residents.

Cases have been reported in Androscoggin (8,346), Aroostook (1,882), Cumberland (17,185), Franklin (1,361), Hancock (1,368), Kennebec (6,550), Knox (1,142), Lincoln (1,074), Oxford (3,616), Penobscot (6,271), Piscataquis (572), Sagadahoc (1,471), Somerset (2,253), Waldo (1,043), Washington (926) and York (13,427) counties.

For a complete breakdown of the county by county data, use the interactive graphic below.

Out of 2,876 COVID-19 tests reported to the Maine CDC in the previous 24 hours, 1.6 percent came back positive. Overall, 2,686,629 tests have been administered and the statewide positivity rate is 2.8 percent.

An additional 1,250 Mainers have been vaccinated against the coronavirus in the previous 24 hours. As of Friday, 730,573 Mainers have received a first dose of the vaccine, while 739,812 have received a final dose.

New Hampshire reported 44 new cases on Friday and three deaths. Vermont reported 14 new cases and no deaths, while Massachusetts reported 120 new cases and seven deaths.

As of Friday morning, the coronavirus had sickened 33,427,925 people in all 50 states, the District of Columbia, Puerto Rico, Guam, the Northern Mariana Islands and the U.S. Virgin Islands, as well as caused 598,797 deaths, according to the Johns Hopkins University of Medicine.

More articles from the BDN

Continue reading here:

Another Mainer has died and 38 more coronavirus cases reported across the state - Bangor Daily News

Spotlight PA is an independent, nonpartisan newsroom powered by The Philadelphia Inquirer in partnership with PennLive/The Patriot-News, TribLIVE/Pittsburgh Tribune-Review, and WITF Public Media. Sign up for our free newsletters.

HARRISBURG The Pennsylvania legislature has voted to immediately end Gov. Tom Wolfs coronavirus disaster declaration using a new power granted to the legislative branch by primary voters, while also keeping in place certain regulatory waivers.

Republicans who advanced the resolution said terminating the emergency order was what Pennsylvanians demanded when they approved two constitutional amendments last month in what was widely seen as a referendum on the administrations pandemic response.

Democrats countered with concerns about the legality of passing the measure before the election results are certified by the Department of State, the possibility it could risk federal funding, and what the potential harms may be especially to low-income households receiving additional food benefits.

Gov. Tom Wolf, a Democrat, cannot veto the resolution.

In a statement, his spokesperson, Lyndsay Kensinger, said Wolf is disappointed that the Republican-controlled General Assembly has not taken action to extend the disaster declaration.

Over the last few weeks the administration has worked hard to educate and inform the General Assembly of the risks associated with ending the COVID disaster declaration prematurely, she said. To avoid serious consequences, the administration will do everything it can to work with the federal government to try to maintain federal funding in the absence of a declaration.

A Department of State spokesperson said the agency is awaiting signed certifications from four of Pennsylvanias 67 counties and expects to receive them by early next week. Wolfs spokesperson said the declaration is not terminated until that occurs.

House Republicans originally sought to continue parts of the declaration through October, while blocking the Wolf administration from putting in place business closures or other mitigation orders. They abruptly changed course Tuesday and passed a resolution to end the entire emergency order in a party-line vote.

The Senate followed suit Thursday, with one Democrat joining Republicans and the chambers sole independent.

At the same time, lawmakers voted to amend an unrelated bill to allow regulatory waivers still in place under the disaster order including an emergency authorization of telemedicine and another that allows retired health-care workers to temporarily return to the field to remain until Sept. 30.

Wolfs spokesperson said the governor will sign the bill.

What happened to tyranny, guys? Rep. Matt Bradford (D., Montgomery) asked his Republican colleagues sarcastically. He called the vote to end the emergency order political theater, as all mitigation orders, save for a universal masking requirement, are no longer in place.

But House Speaker Bryan Cutler (R., Lancaster) said the label was not truthful.

I think it sends the wrong message to our constituents. The reality is, we did work together, he said, noting that the legislature passed 64% of bills unanimously last session (though, as Spotlight PA reported, few addressed the coronavirus). We didnt always agree, but we still found solutions. That is what we are here for.

Just under 52% of voters during the May election backed curtailing the governors emergency powers. Unofficial election results show 2.2 million people voted on the questions, representing roughly a quarter of registered voters.

The constitutional amendments allow a simple majority of lawmakers to terminate a disaster declaration at any time without the governors consent, limit the length to 21 days, and transfer power to extend an emergency order from the executive to the legislature.

Wolf signed the COVID-19 disaster declaration in March 2020 after Pennsylvania announced its first presumptive positive cases of the then-novel coronavirus. Wolf has renewed the measure every 90 days since then, granting him the power to waive certain regulations and mobilize the National Guard.

The order became a Republican target as lawmakers unhappy with business closures the administration put in place to slow the spread of the virus unsuccessfully attempted to force Wolf to reopen the economy on a faster timeline.

Wolf repeatedly said the power to close businesses or limit their operations resides with the secretary of the Department of Health. But preventing future closures became a rallying cry as the GOP urged voters to approve the constitutional amendments.

In the lead-up to the May primary, the Wolf administration had warned ending the disaster declaration could have serious impacts on federal funding. The Department of Human Services said that, without the declaration, it cannot request additional food assistance benefits that have so far benefitted roughly 600,000 households.

You could literally be taking food out of the mouths of babies, out of the mouths of children, Sen. Amanda Cappelletti (D., Montgomery) said Thursday during the debate.

Senate Majority Leader Kim Ward (R., Westmoreland) pointed to Michigan, where the state Supreme Court struck down the governors emergency orders in October. That state is still receiving the emergency allotments as it has separate public health orders in place, according to Wards office.

We certainly have a lot of passion in this chamber on which direction we should have been going, Ward said Thursday, but for all practical purposes, the state of emergency in our commonwealth is over.

WHILE YOURE HERE… If you learned something from this story, pay it forward and become a member of Spotlight PA so someone else can in the future at spotlightpa.org/donate. Spotlight PA is funded by foundations and readers like you who are committed to accountability journalism that gets results.

Go here to see the original:

Legislature votes to immediately end Pa.'s coronavirus disaster declaration while keeping waivers in place Spotlight PA - Spotlight PA

Most of the coronavirus tests deployed in the United States detect specific stretches of RNA, the genetic material of the viruss genome, usually chosen because theyre unique to SARS-CoV-2 (or at least the virus family its in). When the tests fail, its because theyre picky. These molecular tests search the genomic manuscript with about as much precision as the Ctrl+F function on a computer, which means that even single-letter typosthat is, simple RNA mutationscan discombobulate them.

According to the FDA, almost none of these tests is actually pinging back variant-related false negatives, with perhaps the exception of the Accula, made by Mesa Biotech. A document from the company says the test can occasionally be stumped when it encounters mutations in a gene called N (which produces the nucleocapsid protein), leading it to mistakenly say that no virus is present at all. But thats an extreme case. Three other molecular tests identified by the FDA as being affected by mutations are still able to at least partially register the pathogen. (At least two more recently identified by researchers may soon join the list of tests whose detective powers are weakened, but not obliterated, by variants.)

Read: Fewer Americans are getting COVID-19 tests

One test on the FDAs list, Thermo Fisher Scientifics TaqPath, targets a segment of the S coronavirus gene (which encodes the spike protein). A snippet of that segment is missing from several variants of concernincluding the very contagious Alpha (B.1.1.7), the dominant form of the coronavirus in the U.S.rendering S effectively invisible to the TaqPath. But most molecular tests, including the TaqPath, have a de facto insurance policy: They generally scan the genome for multiple RNA segments at a timetwo, three, sometimes moremaking it nearly impossible for the virus to elude the tests scrutiny entirely. The TaqPath, for instance, detects two additional gene segments outside of S, both of which are intact in Alpha, and will still spit out a positive result.

A slightly different set of issues is now playing out with antigen testsa type of rapid test that can usually be done outside a labwhich detect coronavirus proteins. While molecular tests essentially scan genomes letter by letter for precise spelling, tests that search for proteins work more like a reader skimming words for overall meaning. Typos might slip by unnoticed, making antigen tests tougher to flummox with minor mutations. However, while molecular tests typically have multiple targets, antigen tests tend to have only one, usually the nucleocapsid protein, which makes them more brittle, says Alex Greninger, the assistant director of the clinical-virology laboratories at the University of Washington Medical Center.

In a recent paper, not yet published in a scientific journal, Greninger and his colleagues found that a common nucleocapsid-hunting antigen test called the Sofia, made by Quidel, might not recognize a very small fraction of coronavirus variants, incorrectly marking infected samples as virus-free. Greninger told me that the test-confounding mutation is present in less than 0.5 percent of SARS-CoV-2 genomes cataloged to date, so the test itself is fine for now. But the mistake its making isnt necessarily an anomaly. Another recent study, also not yet peer-reviewed, claims a similar issue with a test called the PanBio, made by Abbott. The PanBio isnt available in the U.S., but its similar to another test made by Abbott, the BinaxNOW, that has been authorized by the FDA.

Original post:

Coronavirus Tests Will Never Be Variant-Proof - The Atlantic

As the clock ticks down to the opening of the Tokyo Olympics on July 23, Japan is preparing to host a Games like no other in history, as it grapples with the coronavirus pandemic.

Although the global situation has improved from a year ago, when the Games were postponed for the first time except for war, flare-ups of the disease worldwide mean organisers must hold the sporting extravaganza under strict rules to limit its spread.

Here is a look at the circumstances of these unprecedented Olympics, the second time Tokyo has hosted them since 1964.

SPECTATORS

Foreign spectators have been banned, and organisers are expected to make a decision late this month on domestic spectators.

Toshiaki Endo, vice president of the Tokyo organising committee, told Reuters some spectators could be allowed into venues, although he personally preferred a total ban to calm persistent public opposition to the Games.

The government is considering requiring those who attend to show either negative COVID-19 test results or vaccination records, media said. Bans on loud cheering or high-fives are among other possible steps.

PUBLIC OPINION

While recent opinion polls show some shift towards approval for the Games, earlier surveys revealed that 60% to 80% of respondents would have liked them either cancelled or postponed again. However, the International Olympic Committee (IOC) has said the findings will not affect plans to hold the Games.

The Games have already lost meaning and Japan has been "cornered" into pressing ahead, Kaori Yamaguchi, a member of the country's Olympic panel and a judo medallist, wrote in an opinion piece this month.

BUSINESS ATTITUDES

By the end of May, a growing number of investors in Japanese stocks believed that cancelling the Games would be better for the market. At the same time, a Reuters survey found that nearly 70 percent of businesses also wanted either another postponement or cancellation.

Many sponsors are uncertain how to proceed with advertising campaigns or marketing events because they do not know if domestic spectators will be allowed into the venues, sources at companies directly involved in sponsorship told Reuters.

Some business leaders have been even more outspoken. In May, Hiroshi Mikitani, who heads e-commerce giant Rakuten Group Inc (4755.T), said Japan's low vaccination rate made it a "suicide mission" to host the Games.

MEDICAL SITUATION

Doctors have warned that the Games' need for medical staff could pressure a healthcare system already stressed by caring for virus patients, and officials in some areas have said they would not prioritise Olympics-related patients.

Organisers, though, said in late May they had lined up about 80% of the staff needed, with target numbers cut about a third from 10,000 originally.

Organisers are working with 10 hospitals in Tokyo and 20 outside the capital to ensure response to emergencies.

Repeated warnings on the Olympics from the government's top medical adviser, Shigeru Omi, have included remarks to parliament in early June that holding the Games during a pandemic was "not normal".

Our Standards: The Thomson Reuters Trust Principles.

Read the original:

Factbox: Tokyo Olympics in the shadow of coronavirus - Reuters

A woman who died when she drove the wrong way on a California freeway and hit another car, killing two San Diego police detectives, was a diabetic who may have become disoriented because of low blood sugar, her husband said Tuesday.

Sandra Daniels, 58, died Friday in the high-speed, head-on crash on Interstate 5 near the U.S.-Mexico border south of downtown San Diego. Her car burst into flames.

Read the original:

California now among just 2 states considered to have low coronavirus transmission levels in the U.S. - KTLA Los Angeles

1. How COVID-19 is affecting the globe

Confirmed cases of COVID-19 have passed 173.6 million globally, according to Johns Hopkins University. The number of confirmed deaths stands at more than 3.73 million. More than 2.15 billion vaccination doses have been administered globally, according to Our World in Data.

Plans to ease restrictions in Melbourne, Australia, remain 'on track' Victorian state authorities have said.

New Zealand Prime Minister Jacinda Ardern has said she'll get her first COVID-19 vaccine at the end of the week.

South Korea administered a record number of COVID-19 vaccine doses on Monday - 857,000 - as its rollout picks up speed.

India has reported a daily rise in new COVID-19 infections of 86,498 - the lowest figure in 66 days, according to a government statement.

Researchers in Denmark are using a virtual reality video game to encourage more COVID-19 vaccinations.

Ontario is set to begin loosening COVID-19 restrictions from Friday - 3 days ahead of schedule - as infection rates continue to lower.

The COVID Response Alliance for Social Entrepreneurship is a coalition of 85 global leaders, hosted by the World Economic Forum. Its mission: Join hands in support of social entrepreneurs everywhere as vital first responders to the pandemic and as pioneers of a green, inclusive economic reality.

Its COVID Social Enterprise Action Agenda, outlines 25 concrete recommendations for key stakeholder groups, including funders and philanthropists, investors, government institutions, support organizations, and corporations. In January of 2021, its members launched its 2021 Roadmap through which its members will roll out an ambitious set of 21 action projects in 10 areas of work. Including corporate access and policy change in support of a social economy.

For more information see the Alliance website or its impact story here.

2. Moderna seeks EU, Canadian approval for COVID-19 vaccine's use in teens

Moderna said yesterday that it had submitted applications to the European and Canadian health authorities for authorization to expand the use of its COVID-19 vaccination to adolescents.

It also said it plans to file for emergency use authorization with the United States Food and Drug Administration and other regulatory agencies across the globe for its vaccine to be used in 12 to 17-year-olds.

The company's COVID-19 vaccine is already being used in the United States, EU and Canada in people over 18 years old - among other countries.

3. Vaccine inequality creating 'two-track pandemic'

We're increasingly seeing a 'two-track pandemic' the Director-General of the World Health Organization has warned.

"Many countries still face an extremely dangerous situation, while some of those with the highest vaccination rates are starting to talk about ending restrictions," Dr Tedros Adhanom Ghebreyesus told a media briefing.

He also warned that the inequitable distribution of vaccines is allowing the virus to continue to spread, increasing the risk of a variant emerging that makes vaccines less effective.

"Inequitable vaccination is a threat to all nations, not just those with the fewest vaccines," he said.

Written by

Joe Myers, Writer, Formative Content

The views expressed in this article are those of the author alone and not the World Economic Forum.

Read more from the original source:

COVID-19: What you need to know about the coronavirus pandemic on 8 June - World Economic Forum

As of Tuesday, June 8, the California Department of Public Healths vaccine dashboard showed about 46.9 million doses have been shipped throughout the state (about 700,000 more than a week ago) and of those, 38.6 million have been administered.

Vaccinations in California

According to Bloombergs dashboard tracking vaccine distribution, 58.1% of Californias population has received at least one shot and 44.9% of residents are fully vaccinated (up from 44.2% a week ago). California has the highest daily rate of doses administered in the country at 167,724, up from 163,850 a week ago). The second-highest rate belongs to Texas with 82,621. California was administering about 350,000 doses per day a five weeks ago.

Los Angeles (9.82 million), San Diego (3.53 million) and Orange (3.21 million) counties have administered the most doses to date in California.

Fully vaccinated by county

The chart below compiled by George Karbassis on the website ncovtrack.com shows the percentage of residents in each California county who have had at least one shot or are fully vaccinated. State, nation and world data is compiled on the site as well.

According to ncovtrack.com these are the percentages at which Southern California counties are fully vaccinated:

Los Angeles: 44.48%

San Diego: 49.32%

Orange: 45.71%

Riverside: 35.86%

San Bernardino: 32.78%

The map below is from the California Department of Public Healths COVID-19 vaccinations dashboard and shows vaccinations by ZIP code. Click on the image to go to the site. It may take a few minutes to load.

Vaccinations by age in California:

Data is update once a week on Wednesdays.

Tier assignments as of June 8

On April 6, Gov. Gavin Newsom announced a plan to fully reopen Californias economy on June 15 if current COVID-19 trends hold. California would end its four-colored tier system at that point. Newsom has since said Californias mask mandate might be lifted on June 15 as well.

Until then, the state continues to make weekly adjustments to its tier system and, based on Tuesdays update changes take effect Wednesday none of Californias 58 counties remain in the purple tier (considered widespread risk). There will be three counties in the red tier (one less than a week ago); 31 counties in the orange tier (moderate risk, four less than week ago); and 24 in the yellow tier (minimal risk, five more than a week ago). There were just seven counties in the yellow tier five weeks ago.

On Nov. 24, the state had 41 counties in purple, 11 counties in red, four in orange, two in yellow.

Counties are assigned to a tier based on metrics showing the speed and the spread of the virus in their borders.

The states progression in tiers since Sept. 22:

Here are the California county vaccination totals as of June 8:

Here are the California county vaccination totals as of May 25:

Here are the California county vaccination totals as of May 4:

Sources: covid19ca.gov, California Department of Public Health, U.S. Census, U.S.D.A, California State Association of Counties

[related_articles location=left show_article_date=false article_type=automatic-pri

Read more:

Coronavirus: Vaccination percentages by age in Southern California counties and tier assignments as of June 8 - San Bernardino County Sun