Why Is the FDA Attacking a Safe, Effective Drug? – The Wall Street Journal

Why Is the FDA Attacking a Safe, Effective Drug? – The Wall Street Journal

Valley company sees major increase in COVID-19 tests, positive results – ABC15 Arizona

Valley company sees major increase in COVID-19 tests, positive results – ABC15 Arizona

August 2, 2021

PHOENIX New numbers from health officials show a dramatic increase in the number of people getting tested for the coronavirus.

Additionally, more people are testing positive for the disease.

On Sunday, the state reported more than 2,000 new cases for the second day in a row.

So COVID-19 numbers in Arizona continue to be on the rise, said Data Analyst Garrett Archer.

Theres no question that the number of COVID-19 infections in the community is rising at a pretty rapid rate, Archer added.

Embry Womens Health which operated dozens of testing sites said they were previously testing 1,000 people a day.

However, in July, the company tested about 4,000 a day.

"And if we follow the same type of curves as places like Japan or Florida, this is only the beginning, said Embry CEO Raymond Embry.

Embry said people not social distancing, not wearing a mask, low vaccine rates and the delta variant may be playing a factor.

Unfortunately, what we're consistently hearing is that people are being exposed to others who have come back for COVID-19 or they've been around somebody who has been sick, said Embry.

Both Embry and the state offer COVID-19 testing at no cost.


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Valley company sees major increase in COVID-19 tests, positive results - ABC15 Arizona
COVID-19 Vaccine – Hawaii DOH: Info & Resources for …

COVID-19 Vaccine – Hawaii DOH: Info & Resources for …

July 31, 2021

The Hawaii Department of Health is collaborating with businesses and organizations across the state to host #HIGotVaccinated events and promotions that encourage all residents ages 12 years and older to get their COVID-19 vaccine. With the help of our partners, COVID-19 vaccines are now easily accessible with walk-ins and extended hours at many vaccination sites.


View post: COVID-19 Vaccine - Hawaii DOH: Info & Resources for ...
COVID-19 Vaccine Breakthrough Cases: Data from the States – Kaiser Family Foundation

COVID-19 Vaccine Breakthrough Cases: Data from the States – Kaiser Family Foundation

July 31, 2021

While COVID-19 vaccines are highly effective at preventing severe disease, hospitalization, and death from COVID-19 and also reduce the likelihood of mild or asymptomatic infection, a small share of fully vaccinated individuals do become infected, and some become hospitalized or have died. These rare occurrences are known as breakthrough cases which are to be expected, and historically known to occur with other vaccines as none is 100% effective.

The Centers for Disease Control and Prevention (CDC) currently monitors hospitalizations and deaths, from any cause, among fully vaccinated individuals with COVID-19, but not breakthrough infections, which it stopped monitoring as of May 1. CDC presents this data in aggregate at the national level but not by state, and there is no single, public repository for data by state or data on breakthrough infections, since the CDC stopped monitoring them.

We therefore reviewed the websites and other official state sources for all 50 states and D.C. to see which are providing data on COVID-19 breakthrough cases, hospitalizations and deaths, how regularly, and what those data may tell us. We only used data from official state sources (we did not include data available only in news media reports, for example). Where a state did not provide comparable data on overall COVID-19 cases, hospitalizations, or deaths reported over the period in which it captured breakthrough events, we obtained data on cases and deaths from the Johns Hopkins University COVID-19 Dashboard and on hospitalizations from the U.S. Department of Health & Human Services for the appropriate period (see methods for more detail).

Importantly, not all hospitalizations and deaths of those fully vaccinated and diagnosed with COVID-19 are due to COVID-19 or have a known cause at the time of reporting. The CDC reports that as of July 19, of 5,601 hospitalized breakthrough cases, 27% were asymptomatic or not related to COVID-19 and of 1,141 fatal cases, 26% were asymptomatic or not related to COVID-19. States differ in whether they provide this detail. DC, for example, reports that as of July 11, 50% of hospitalized breakthrough cases were due to COVID-19, 19% were not, and 31% were of unknown reason. However, few states made these distinctions. Where they did, we only included breakthrough hospitalizations and deaths due to COVID-19. In other cases, some of these breakthrough events may be due to causes other than COVID-19.

Overall, we find that:

While information on breakthrough events is still limited and incomplete, this analysis of available state-level data indicates that COVID-19 breakthrough cases, and especially hospitalizations and deaths, among those who are fully vaccinated are rare occurrences in the United States. Moreover, this data indicate the vast majority of reported COVID-19 cases, hospitalizations, and deaths in U.S. are among those who are unvaccinated or not fully vaccinated. These findings echo the abundance of data demonstrating the effectiveness of currently authorized COVID-19 vaccines. Moving forward, particularly as the more transmissible Delta variant is now the dominant strain of COVID-19 circulating in the U.S., more robust state-level data will help to monitor ongoing vaccine effectiveness and inform discussions about booster vaccinations.

We utilize two approaches in our analysis. The first assesses the share of fully vaccinated individuals that have experienced a COVID-19 event (i.e. diagnosis, hospitalization, or death) within each state. The second assesses the share of total COVID-19 cases, hospitalizations, and deaths attributable to fully vaccinated individuals compared to individuals who are not fully vaccinated within each state. Individuals who are not fully vaccinated may include those who are not vaccinated, partially vaccinated, or have an unknown vaccination status. In some cases, it is not possible to determine whether a hospitalization or death of a vaccinated individual with COVID-19 was due to COVID-19.


Continue reading here: COVID-19 Vaccine Breakthrough Cases: Data from the States - Kaiser Family Foundation
Doctors stress value of COVID-19 vaccine, even with uptick in breakthrough cases – WRAL.com

Doctors stress value of COVID-19 vaccine, even with uptick in breakthrough cases – WRAL.com

July 31, 2021

By Joe Fisher, WRAL reporter

Across the country, as more breakthrough COVID-19 cases are reported, some people still not vaccinated have raised questions about getting the shot.

But doctors said that, yes, getting vaccinated offers significant protection serious illness.

Even with the Delta variant spreading, 92 percent of North Carolina's COVID-19 cases are among the unvaccinated.

We expect this incline to continue rising," said infectious disease expert Dr. Cameron Wolfe, of Duke University.

In Wake County, 2.9 percent of the positive COVID-19 cases between Jan. 23 and July 28 were breakthrough cases. A Wake County spokeswoman said that, while that number could rise, it's lower than the state's percentage of about 6 percent of breakthrough cases.

Even with the more contagious Delta variant, some said they aren't convinced to roll up their sleeves.

"I'd rather just wear my mask, stay safe and continue to social distance," said Raleigh resident Ashley Peterson.

Peterson said she's never gotten a flu shot and doesn't plan on getting a COVID-19 shot.

"You don't really know whats going inside your body," said Peterson.

Peterson said there's nothing someone could tell her that would make her want to get the shot.

"If I don't have to get vaccinated, I am not going to," she added.

Peterson is not alone. In fact, doctors said its the unvaccinated driving the spike in hospitalizations and new cases.

"These are not brand new vaccines. They have, in fact, been built on technology that has evolved and built on science that has evolved over decades," said Wolfe. "That's really important for people to recognize."

Since the start of the pandemic, the virus has claimed the lives of more than 13,000 people in North Carolina.

Just since May, theres been 354 deaths, with only 21 of those individuals being fully vaccinated.

That means the unvaccinated account for 94% of deaths in the last three months.

"The one nice thing about the Delta variant is that the vaccines still work against it," said Dr. David Montefiori, a virologist at Duke University.

Montefiori acknowledged the breakthrough cases, but he said vaccinated people who contract the virus often have much milder symptoms.

Those people are shedding virus, and they are capable of transmitting," said Montefiori. "But they're shedding less virus than a non-vaccinated person, and they're shedding that virus for a shorter period of time.

As the push continues to get shots into arms, Peterson said shes turned off by the mounting pressure.

I dont like the idea of being forced to have to do something or get something. I dont like that," said Peterson.

In Wake County, new cases have shot up 279% since the beginning of June.

Doctors said the big takeaway is that the vaccine is key to preventing hospitalizations and deaths.


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Doctors stress value of COVID-19 vaccine, even with uptick in breakthrough cases - WRAL.com
Public Health recommends mandatory COVID-19 vaccination for healthcare workers – Public Health Insider

Public Health recommends mandatory COVID-19 vaccination for healthcare workers – Public Health Insider

July 31, 2021

Public Health Seattle & King County is recommending mandatory COVID-19 vaccinations for healthcare personnel and strongly encourages healthcare facilities and long-term care employers in King County to follow this recommendation.

The recommendation is an endorsement of the multisociety statements from wide range of medical, healthcare, and public health professional societies and organizations stating that COVID-19 vaccination should be a condition of employment for all healthcare personnel.

As highlighted by 31 national professional organizations, including the American Medical Association, American College of Physicians and American Nurses Association, requiring vaccination among healthcare workers is important for patient and healthcare worker safety.

Excerpt adapted from multisociety statement by the Society for Healthcare Epidemiology of America et. al.:

Full vaccination against COVID-19 offers several advantages to patient and healthcare personnel safety. This includes:

I strongly support hospitals, health systems and long-term care systems in adopting mandatory COVID-19 vaccination policies for their healthcare personnel, said Dr. Jeff Duchin, Health Officer, Public Health Seattle & King County. No patient should have to worry about getting COVID-19 from a healthcare provider. Protection against COVID-19 reduces the risk of severe illness and protects the safety of patients, healthcare workers, families and our community.

Read Public Healths statement.

Originally posted July 30, 2021


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Public Health recommends mandatory COVID-19 vaccination for healthcare workers - Public Health Insider
These companies are requiring COVID-19 vaccines for their employees – WFLA

These companies are requiring COVID-19 vaccines for their employees – WFLA

July 31, 2021

SAN FRANCISCO, Calif. (KRON) As the United States faces yet another coronavirus surge, vaccinations are being highly encouraged and in some cases required for employees at certain companies.

Some major tech giants announced this week their employees would have to show proof theyve been fully vaccinated before returning to work.

Below is a list of companies and their vaccination guidelines.

Google

Google announced Wednesday it is postponing a return to the office for most workers until mid-October and rolling out a policy that will eventually require everyone to be vaccinated once its sprawling campuses are fully reopened.

In an email sent to Googles more than 130,000 employees, CEO Sundar Pichai disclosed that once offices are fully reopened, everyone working there will have to be vaccinated.

The requirement will be first imposed at Googles Mountain View headquarters and other U.S. offices before being extended to the more than 40 other countries where the Google operates.

The vaccine mandate will be adjusted to adhere to the laws and regulators of each location, Pichai wrote, and exceptions will be made for medical and other protected reasons.

Getting vaccinated is one of the most important ways to keep ourselves and our communities healthy in the months ahead, Pichai explained.

Facebook

Facebook employees returning to U.S. campuses will be required to be vaccinated against COVID-19, according to Facebook Vice President Lori Goler.

Goler continued in a statement posted to Twitter that the company will work with people who cannot be vaccinated for medical or other reasons.

Netflix

Netflix is mandating COVID-19 vaccinations for the casts of all of its U.S. productions making it the first major Hollywood studio to implement a mandate, according toDeadline.

The mandate also applies to those who come into close contact with cast members on set.

Lyft

In an email CEO Logan Green sent to employees, all employees working in Lyfts offices are required to be vaccinated, according to CNN Business.

Additionally, the majority of Lyft offices in the U.S. will return to the office on Feb. 2, 2022, according to the email.

Uber

Uber employees who want to go back into the office must be fully vaccinated, CEO Dara Khosrowshahi said in a memo sent to employees.

Similar to other companies, Uber pushed back its global return to office date to Oct. 25, and said it will provide updates by Sept. 30 if anything changes.

Anyone coming into the office must wear a mask for the time being, regardless of their vaccination status, Khosrowshahi said.

Twitter

Twitter is requiring employees who return to the office to show proof of vaccination.

On Wednesday, the company took additional steps of closing its offices in New York and San Francisco completely and pause further office reopenings.

Walmart

In a memo, Walmart announced that associates who work in multiple facilities, and associates of its campus office, will need to be vaccinated by Oct. 4.

On Friday, Walmart also required associates, including those fully vaccinated, to wear masks in its stores.


View original post here: These companies are requiring COVID-19 vaccines for their employees - WFLA
INVESTIGATES: Paying people to get the COVID-19 vaccine – ActionNewsJax.com

INVESTIGATES: Paying people to get the COVID-19 vaccine – ActionNewsJax.com

July 31, 2021

JACKSONVILLE, Fla. Action News Jax is investigating whether state or local governments plan to give out money as an incentive to get people vaccinated.

On Thursday, Action News Jax reported the Biden administration wants to give $100 to unvaccinated people to get the vaccine and suggests states use money given to them from the federal COVID-19 recovery efforts to pay it.

STORY: DCPS mask update requires faculty to wear masks for 30 days starting Aug. 2

The City of Jacksonville told Action News Jax it is not offering incentives right now and doesnt have plans to use money from recovery funds for any vaccine incentive program.

On an average day, getting $100 doesnt sound too bad, but if it means getting the COVID-19 vaccine, Lucretia Chappell is turning it away.

Honestly, in my opinion thats what makes it suspect, thats what scares me, she said. The incentives dont matter, its health that matters.

Action News Jax reported Wednesday the city will receive more than $300 million in federal funds from the American Rescue Plan, but again, there is no current plan to use it for vaccine incentives.

I think 100 bucks is still something, Linda Wiley said.

STORY: Hella Mega Tour to light up TIAA Bank Field under COVID precautions

In St. Johns County, Action News Jax was told in an emailed response the Board of County Commissioners has not made any policy decisions on the appropriation of the local American Rescue Plan funds, as the county hasnt gotten them yet.

The county spokesperson said the CARES Act funding has already been budgeted.

The governors office told Action News Jax on Thursday there are no funds for the $100 incentive because all of the state recovery funds had been budgeted.

On Friday, we learned the governors office would not be pushing legislature to do something or call a special session, saying, If the incentive was extended to everyone in Florida who already got vaccinated, it would be more than $1 billion already, without even starting on the new people who get vaccinated from this day forward.

President Joe Biden recommended the money only be given to new people who get the vaccine.

I understand why hes doing it because he has to go to the next level, its just a little tough because the people who procrastinated get a little more, Wiley said.

Action News Jax went into City Hall for the Mayors public schedule. He only had one appointment from 8-9 a.m. and a phone call scheduled at 3 p.m., but his office was not able to fit us in for an interview.

2021 Cox Media Group


Excerpt from: INVESTIGATES: Paying people to get the COVID-19 vaccine - ActionNewsJax.com
Medical experts hoping for youth COVID-19 vaccination availability by September – Joplin Globe

Medical experts hoping for youth COVID-19 vaccination availability by September – Joplin Globe

July 31, 2021

As the delta variant continues to significantly affect the younger population, medical experts are hoping to have COVID-19 vaccinations available for youth this fall.

Pfizer-BioNTech has requested authorization from the U.S. Food and Drug Administration to expand the emergency use of their COVID-19 vaccine for individuals ages 12 to 15. Albert Bourla, Pfizer chairman and CEO, said during a quarterly earnings conference call in May that they plan to submit an emergency use authorization for two groups children ages 2 to 5 and 5 to 11 years of age in September.

I think that timing is a little unfortunate, but thats just one parents opinion, said Dr. Robert McNab, Freeman Health System director of COVID-19 services.

Mercy Hospital in Joplin and Freeman Health Systems have both reported a recent uptick in COVID-19 patients needing ventilators and intensive care, especially among younger adults. This is largely due to the fast-spreading delta variant, which is now the dominant COVID-19 variant in the United States.

On Friday, Freeman Health System reported 57 inpatients with COVID-19 in its Joplin and Neosho hospitals, 12 of them in intensive care and 10 on ventilators. About 92% of the current inpatients are not vaccinated.

With the rest that we got a few months ago, I think we all were very, very hopeful that we had gone around that curve, and we werent going to have this level of disease again, said Paula Baker, Freeman president and CEO. But unfortunately, it has returned with a vengeance. Its a very different situation than we had hoped for.

Mercy Hospital Joplin reported 75 patients Friday at its clinics in Joplin and Carthage, 16 of whom are in intensive care and 20 of whom are on ventilators.

Freeman Health System held a media briefing Friday in Joplin to address the latest surge in COVID-19 cases in the region. Hospitalizations have been on the rise, with the overall death toll among COVID-19 patients rising as well.

Medical leaders have likened the recent spike in cases to last years winter peak in which officials saw an average of one death per day. At Freeman, McNab reported 30 community members died of COVID-19 in July alone.

As I look at the numbers today, consistently two-thirds of all the (COVID) inpatients are in their middle 60s and younger, and thats a very different population than what weve really been experiencing in the past year and a half, McNab said. Its a younger, much healthier population that is now getting much sicker, and I think its because of this delta variant.

The Centers for Disease Control and Prevention recently reversed its K-12 school mask guidance to include masks to be worn by everyone, despite vaccination status. With the fall semester around the corner, many parents are left wondering what this year will look like for their children.

Previously, they (CDC) had said if you are fully vaccinated and you want to go about the world without a mask, thats a more reasonable thing to do, McNab said. But they kind of walked that back a little bit, and the reason for that is because we know that its possible for the vaccinated to get this infection and for them to carry that infection and be asymptomatic and be able to spread that into the population further.

Baker said she predicts several school districts will heavily rely on masks this year to combat the spread.

I think a lot of schools will be requiring masks during the school day, which I personally think is a really good idea, Baker said. Its just a protection for the children in that environment where its a little more difficult for them to maintain appropriate distances.

Freeman opened a third treatment ward for COVID-19 patients last week in response to the growing infections. The intermediate treatment unit was created for seriously ill patients with respiratory failure, rather than sending them to the ICU, where more space is needed for ventilator patients and other critical patients.

McNab said the intermediate unit has been successful at giving COVID-19 inpatients the next level of care, which is a step down unit from the ICU level. The new unit has averaged anywhere from 10 to 13 patients per day. About 20% of beds at Freeman are now being used for COVID-19 patients, according to McNab.

It allows us to open up more ICU resources for those people that are really, really ill, he said.

The only way out of the pandemic is to get people in the community vaccinated, McNab said, to reach herd immunity. The more the virus mutates, the more it runs the risk that current vaccinations could lose efficacy, he added.

The more that we can all do as a community, I think the better the results that were going to get, he said.


Excerpt from: Medical experts hoping for youth COVID-19 vaccination availability by September - Joplin Globe
Advantages of Intranasal COVID-19 Vaccinations Over Injections – SciTechDaily

Advantages of Intranasal COVID-19 Vaccinations Over Injections – SciTechDaily

July 31, 2021

Of the nearly 100 SARS-CoV-2 vaccines currently undergoing clinical trials, only seven are delivered intranasally despite this vaccine types long success in providing protection from influenza.

In a Perspective, Frances Lund and Troy Randall argue that intranasal vaccines could be beneficial in the continued fight against COVID-19, especially considering respiratory viruses like SARS-CoV-2 predominantly enter the nasal passage first.

Currently authorized COVID-19 vaccines are delivered via intramuscular injection, where they elicit systemic immune responses and central immune memory. While several versions are currently being administered worldwide, many more are in development. However, according to the authors, given the respiratory propensity of the virus, it is surprising that so few intranasal vaccines, which deliver their antigens directly to the site of infection, are being considered.

Here, Lund and Randal discuss the potential of intranasal COVID-19 vaccines, highlighting their advantages, drawbacks and rationale for use over intramuscular options. In addition to being needle-free, intranasal vaccines provide two additional layers of protection compared to intramuscular vaccines. Intranasal vaccine-elicited immunoglobulin A (IgA) and resident memory B and T cells in the nasal passages and upper airways provide a barrier to infection, impede viral replication and reduce viral shedding.

Lund and Randall note that effective vaccination strategies need not be restricted to a single delivery system and suggest that an ideal vaccination strategy may consist of an intramuscular vaccine combined with an intranasal booster.

For more on this perspective, read Scent of a Vaccine: Many Advantages to Intranasal COVID-19 Vaccination.

Reference: Scent of a vaccine by Frances E. Lund and Troy D. Randall, 23 July 2021, Science.DOI: 10.1126/science.abg9857


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Advantages of Intranasal COVID-19 Vaccinations Over Injections - SciTechDaily
Waiving IP rights for COVID-19 vaccines is dangerous for innovation, jobs and patients | Opinion – NorthJersey.com

Waiving IP rights for COVID-19 vaccines is dangerous for innovation, jobs and patients | Opinion – NorthJersey.com

July 31, 2021

Debbie Hart| Special to the USA TODAY Network

Biden: Proof of vaccination or COVID tests needed for federal workers

Federal employees will be required to show they are fully vaccinated or be forced to undergo regular COVID tests and submit to safety measures.

Associated Press, USA TODAY

Thank you, science.

Three simple words capturethe powerful impact thatmedical innovationshaveonourhealth, well-being, andquality oflife in thetimeof a pandemic.The incredibleefforts ofthebiopharmaceutical sector overthepastyear andevenyears before the COVID-19 pandemic brought vaccines to market for COVID-19 at a rapid pace.In order to bring an end to the pandemic, it is critical that we ensure broadaccess tothese vaccines across the globe, but we must do so in a way that protects theintellectual property that allowedusto produce the vaccineswe have today and need tomorrow.

Unfortunately, the U.S. recently announced that it would support aWorld Trade Organization proposal to waiveintellectual propertyprotections for COVID-19 vaccines, a decision that wouldcreateanegative ripple effect on theinnovation sector in New Jerseyand beyondand the very patients whoneedsafe and effectivevaccines andtreatmentsthe most.Waiving IP protections would threaten the future development of innovative treatments in the most critical momentsand ignore moreeffective ways to ensure global vaccine access during a crisis that dont put innovation and patients in jeopardy.

IP protections on medical products exist togivepatientsconfidence that they willreceive treatmentsthat are backed by rigorous safety and efficacy standardsandensurecompanies cancontinue to develop innovative drugsfor complex disease.Known commonly as the TRIPS waiver, WTO proposed the IP waiver under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), an international legal agreement between all member nations of the WTO.The intent may be right to expand access to lifechanging vaccines across the globe but the consequences could be vast and dangerous.

WaivingIPprotections forCOVID-19vaccines thatshowcasethe very best of the biopharmaceutical sector including the companies that call New Jersey homenot only doesnt guarantee faster rollout for vaccines abroad but could undermine the standards for these drugs and the supply chain that has demonstrated efficacy throughout the pandemic.

The notion that waiving IP protections iscriticalto saving lives abroad diminishes the work that American companies have done to develop groundbreaking drugs andunderminestheir continued commitment to savinglives and changingthe way we treat and manage complex diseases.There are alternativesolutions,includingthe Biotechnology Innovation OrganizationsproposedGlobalSHAREProgram, which would ensure continued global vaccine accesswithout threateningAmerican jobs and innovation.

There is no question that the fight is not over against COVID-19.But disrupting the production of these difficult to manufacture vaccines andthreatening future drug developments is notthe way to solve the ongoing challenges of the pandemic.Instead, we should bolster the existing manufacturing framework, hardworking Americans, and valuable sciencehere in New Jersey and across the country.In New Jersey alone, more than70companies continue to work to combat the effects of the coronavirus.This approach not only secures U.S. jobs andthehomegrowninnovationthatarecentral pillarsof the Biden Administration,butcontinues toachieve the global objective of turning the corner on the COVID-19pandemic.

All of the more than 160 member countries of the WTOmustsupport such a wavier for ittomove forward, so weawait next steps. But we hopethe Biden Administrationwill see how such a decision would change the trajectory ofthe COVID-19 response,innovation for New Jersey,and the entire U.S. economy.Itisimperative that wework together to put shots in more arms in a time of crisis. But thisisnot the way to do it.

Debbie Hart is the president and CEO ofBioNJ, based in Trenton.


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Waiving IP rights for COVID-19 vaccines is dangerous for innovation, jobs and patients | Opinion - NorthJersey.com