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Pfizer asks US officials to OK promising COVID-19 pill

WASHINGTON – Pfizer asked U.S. regulators Tuesday to authorize its experimental pill for COVID-19, setting the stage for a likely launch this winter of a promising treatment that can be taken at home.

The company’s filing comes as new infections are rising once again in the United States.

Pfizer’s pill has been shown to significantly cut the rate of hospitalizations and deaths among people with coronavirus infections. The Food and Drug Administration is already reviewing a competing pill from Merck, and several smaller drugmakers are also expected to seek authorization for their own antiviral pills in coming months.

“We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application,” Pfizer CEO Albert Bourla said in a statement.

Specifically, Pfizer wants the drug available for adults who have mild to moderate COVID-19 infections and are at risk of becoming seriously ill. That’s similar to how other drugs are currently used to treat the disease. But all FDA-authorized COVID-19 treatments require an IV or injection given by a health professional at a hospital or clinic.

The FDA is holding a public meeting on the Merck pill later this month to get the opinion of outside experts before making its decision. The agency isn’t required to convene such meetings and it’s not known whether Pfizer’s drug will undergo a similar public review.

Some experts predict COVID-19 treatments eventually will be combined to better protect against the worst effects of the virus.

Pfizer reported earlier this month that its pill cut hospitalizations and deaths by 89% among high-risk adults who had early symptoms of COVID-19.

The company studied its pill in people who were unvaccinated and faced the worst risks from the virus due to age or health problems, such as obesity. If authorized, the FDA will have to weigh making the pill available for vaccinated people dealing with breakthrough infections, since they weren’t part of the initial tests.

For best results, patients need to start taking the pills within three days of symptoms, underscoring the need for speedy testing and diagnosis. That could be a challenge if another COVID-19 surge leads to testing delays and shortages seen last winter.

Pfizer’s drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme that viruses need to multiply in the human body. That’s different than the Merck pill, which causes tiny mutations in the coronavirus until the point that it can’t reproduce itself.

On Tuesday, Pfizer signed a deal a with United Nations-backed group to allow generic drugmakers to produce low-cost versions of the pill for certain countries.

In a statement issued Tuesday, Pfizer said it would grant a license for the antiviral pill to the Geneva, Switzerland-based Medicines Patent Pool, which would let generic drug companies produce the pill for use in 95 countries, making up about 53% of the world’s population.

Merck has a similar deal for its pill, which was authorized in Britain earlier this month.

The U.S. has approved one other antiviral drug for COVID-19, remdesivir, and authorized three antibody therapies that help the immune system fight the virus. But they usually have to be given via time-consuming infusions by health professionals, and limited supplies were strained by the last surge of the delta variant.

The U.S. government has already committed to purchasing Merck’s pill. Federal authorities were in negotiations with Pfizer to buy millions of doses of its pill, according to an official familiar with the matter.


Around 34 inflatable turkeys stand in the yard of "flock masters" Teresa and Greg Hardcastle's home on Willow Way in Bowling Green, Ky., on Tuesday, Nov. 16, 2021. Hardcastle, who said it all started with finding marked-down inflatable turkeys for sale after Halloween six or seven years ago, felt the need to "save the turkeys, one Thanksgiving at a time," adding more turkeys each year. The Hardcastles invite the public to come take pictures with the turkeys but warn for visitors to watch for cables and other wires running through the yard. The turkeys run on a timer from about 6 a.m. each morning until just after dark from November 1 through Thanksgiving weekend. (Grace Ramey/photo@bgdailynews.com)


Around 34 inflatable turkeys stand in the yard of "flock masters" Teresa and Greg Hardcastle's home on Willow Way in Bowling Green, Ky., on Tuesday, Nov. 16, 2021. Hardcastle, who said it all started with finding marked-down inflatable turkeys for sale after Halloween six or seven years ago, felt the need to "save the turkeys, one Thanksgiving at a time," adding more turkeys each year. The Hardcastles invite the public to come take pictures with the turkeys but warn for visitors to watch for cables and other wires running through the yard. The turkeys run on a timer from about 6 a.m. each morning until just after dark from November 1 through Thanksgiving weekend. (Grace Ramey/photo@bgdailynews.com)


News
Defense reviewing evidence in BG murder case

The attorney for a man accused in a deadly shooting on Glen Lily Road is reviewing evidence provided by the prosecution.

Eder Exequiel Martinez-Pineda, 30, of Bowling Green, appeared Tuesday in Warren Circuit Court for a pretrial conference in a case in which he has been charged with murder and tampering with physical evidence.

Martinez-Pineda is accused of shooting Gregorio Alberto Jimenez, who was found June 3 with multiple gunshot wounds in front of a property in the 700 block of Glen Lily Road.

Attorney Kevin Croslin, who represents Martinez-Pineda, updated the court on the status of his work.

“We are still in the process of going through the discovery,” Croslin said. “We are about halfway through, there are some recorded phone calls that have to be translated.”

Croslin requested another pretrial conference, saying that after reviewing the evidence and discussing the matter with Warren County Commonwealth’s Attorney Chris Cohron, he will be in a better position to know how to proceed.

Warren Circuit Judge Steve Wilson ordered Martinez-Pineda to return to court Jan. 24.

Martinez-Pineda was arrested June 8 in Tompkinsville, five days after the shooting.

During a preliminary hearing in June in Warren District Court, Bowling Green Police Department Detective David Grimsley said investigators learned Jimenez had apparently been to a home on Collegeview Drive the day before the shooting to fight someone who lived there.

City police went to the home June 4 and found a black 2015 Chevrolet Suburban parked in the driveway, matching the description of a vehicle given by a resident on Glen Lily Road who reported hearing gunshots within a minute of seeing the vehicle drive past his home.

The Suburban was found to be registered to Martinez-Pineda’s brother Jayro Pineda, who arrived at the home on Collegeview Drive soon after police got there.

Police asked where Pineda had been the previous evening, and he replied that he had been to a restaurant with his family.

When he was asked about whether the Suburban had been involved in a shooting, Pineda refused to speak further, Grimsley testified.

The BGPD received a call from Martinez-Pineda’s ex-wife, who claimed Martinez-Pineda admitted to her that he shot Jimenez, Grimsley said.

The ex-wife agreed to make a recorded phone call to Martinez-Pineda from BGPD headquarters, and during the call Martinez-Pineda was asked about the gun allegedly used, and he said he gave it to his brother, the detective testified.

Martinez-Pineda is one of three people charged in Jimenez’s death.

Jayro Pineda is charged with tampering with physical evidence based on an allegation that he was given the weapon used in the shooting to dispose of it.

Brittany Miller, identified in prior court testimony as Martinez-Pineda’s girlfriend, has been indicted on a charge of first-degree hindering prosecution or apprehension. Miller is accused of withholding knowledge of Martinez-Pineda’s whereabouts from police investigating the homicide.

– Follow courts reporter Justin Story on Twitter @jstorydailynews or visit bgdailynews.com.


News
State funds helping Logan industrial park

An investment from the Kentucky Economic Development Finance Authority should make it more attractive for employers to invest in Logan County.

KEDFA in October approved a Product Development Initiative grant of $335,361 that will help the Logan Industrial Development Authority prepare a 52-acre site that is being added to the county’s West Industrial Park.

Combined with a Tennessee Valley Authority grant and other funding, the KEDFA money will be used for site preparation and to build a road into what was American Legion and Logan County Fairgrounds property along U.S. 68-Ky. 80.

The 52 acres will boost the size of the West Industrial Park to 167 developable acres and, perhaps more importantly, will make it easier to access the acreage that is being marketed to industrial prospects.

“By adding this acreage, the industrial park will now have access from two four-lane highways: the Jefferson Davis Highway and the bypass,” Logan County Judge-Executive Logan Chick said. “It will make the park more attractive and allow us to do some good things.”

Logan Economic Alliance for Development Executive Director Jim DeCesare said work on the site will begin in the spring and should make the property attractive to industrial prospects.

“The West Industrial Park is phenomenal,” DeCesare said. “It is accessible by rail and a four-lane state highway and has all the utilities any industry needs. The PDI grant allows us to make additional site improvements needed to attract an advanced manufacturing facility to Logan County.”

Chick said interest in Logan County is high from potential employers.

“We’ve had more activity recently than we’ve ever had before,” he said. “But we’re competing with the world. I’m looking forward to improving that park.”

The expansion of the West Industrial Park is hardly the only economic development activity in Logan County, according to DeCesare.

He said the county’s 93-acre Shelton Lane Industrial Park should soon be home to a “speculative” building that can be used to attract industrial prospects.

“We have a request for proposals out now for a ‘spec’ building,” DeCesare said. “We’ll get proposals in December and go from there. Having that property presentable and ready for use is what the end game is.”

Logan County is also targeted as the site of a 1,600-acre solar farm to be developed by Nashville-based Silicon Ranch as part of TVA’s Green Invest program.

Silicon Ranch is investing more than $150 million to build the solar array that will provide power to two specific customers: Facebook’s data center in Gallatin, Tenn., and the General Motors Corvette Assembly Plant in Bowling Green.

The logancountykysolar.com website said the 173-megawatt solar farm will include 493,000 solar modules on what had been farmland.

Construction of the solar farm on property along Watermelon and Montgomery roads, to the southwest of Russellville, is expected to begin early next year and be completed in 12 to 18 months.

– Follow business reporter Don Sergent on Twitter @BGDNbusiness or visit bgdailynews.com.


Around 34 inflatable turkeys stand in the yard of "flock masters" Teresa and Greg Hardcastle's home on Willow Way in Bowling Green, Ky., on Tuesday, Nov. 16, 2021. Hardcastle, who said it all started with finding marked-down inflatable turkeys for sale after Halloween six or seven years ago, felt the need to "save the turkeys, one Thanksgiving at a time," adding more turkeys each year. The Hardcastles invite the public to come take pictures with the turkeys but warn for visitors to watch for cables and other wires running through the yard. The turkeys run on a timer from about 6 a.m. each morning until just after dark from November 1 through Thanksgiving weekend. (Grace Ramey/photo@bgdailynews.com)


News
WCPS sees spike in COVID cases after going mask-optional

Active COVID-19 cases among Warren County Public Schools students have more than tripled since the district dispensed with its universal masking policy Nov. 1, the school district’s case dashboard shows.

On Oct. 25, one week before the school district pivoted to a mask-optional policy for its schools, WCPS reported 19 active student cases on its dashboard. That number has since grown to at least 73 active student cases as of Tuesday afternoon.

For comparison, the Bowling Green Independent School District – which has chosen to keep its universal masking requirement for at least one more month – reported 17 active student cases on its district dashboard Tuesday morning.

“At the Warren County Public Schools monthly board meeting on Oct. 21, 2021, board members voted to make face coverings optional in our school facilities and extra-curricular events, beginning Nov. 1, 2021,” a statement from a WCPS spokesperson attributed to Superintendent Rob Clayton said Tuesday.

“At that time, our community was experiencing a consistent decline in confirmed COVID-19 cases. During the past couple of weeks, COVID-19 cases in our schools have mirrored the steady increase we are currently experiencing throughout our community.

“During today’s Kentucky Department of Education Commissioner’s webcast, Dr. Connie White, Deputy Commissioner of the Kentucky Department of Health, expressed optimism that we may have reached a plateau of COVID cases based upon current data and previous trends throughout the pandemic. However, consistent with our approach from the beginning of the pandemic, we will continue to monitor the fluctuation of data daily and any adjustments made to our current COVID protocols will be communicated to our families in as timely a manner as possible.”

Explaining the policy shift, Clayton said last month he was making the recommendation to go mask-optional based on factors like improvements to local hospital capacity, community virus incidence rate and the district’s quarantine rate and quarantine numbers.

“Based on these metrics, we’re optimistic that we can continue to provide in-person instruction five days per week with masks being an option,” Clayton said during the district’s school board meeting last month.

That said, the district’s school board and superintendent were also under pressure by parents opposed to universal masking in schools and who frequently showed up during board meetings to voice their displeasure.

Children, including very young children, can and do develop COVID-19. Those who do get sick tend to experience milder symptoms such as low-grade fever, fatigue, and cough. However, some children have had severe complications, though this has been less common.

Compared with adults, children and adolescents who are infected with coronavirus are more commonly asymptomatic or have mild, non-specific symptoms (e.g. headache, sore throat). Similar to adults with coronavirus infections, children and adolescents can spread coronavirus to others when they do not have symptoms or have mild, non-specific symptoms and thus might not know that they are infected and infectious, according to the Centers for Disease Control and Prevention.

The change to making face coverings optional in the district’s schools also came with a shift in its quarantine protocol.

Students who aren’t exhibiting COVID-19 symptoms – such as fever, new cough, difficulty breathing, sore throat, muscle and body aches, vomiting or diarrhea or new loss of taste or smell – are no longer required to quarantine in the event of an exposure to COVID-19 at school.

However, per its COVID-19 protocol posted on the district’s website, quarantining will continue for exposures that take place outside of school “because these cases are under the authority of our local health department.”

The new policy is out of step with guidance from state and national public health experts. Both the Kentucky Department of Education and the CDC urge universal masking in schools for all children age 2 and older, regardless of vaccination status.

Masks are also still required on the district’s school buses, Clayton wrote in a recent message posted on the district’s website.

“Although masks are now optional in our school buildings and on school property, please know that masks are still required on our school buses. This is due to the large number of students who sit in close proximity with one another for an extended period of time,” Clayton wrote.

WCPS initially began the year without mandating masks but soon reversed course and implemented a requirement after hundreds of students and staff entered quarantine within the first week of school. At one point, the number of students in quarantine reached at least 1,700.

In recent weeks, as more school districts across the state have moved to a mask-optional approach, Gov. Andy Beshear has urged local school boards to keep the mask mandates in place, warning it would erase statewide improvements to COVID-19 cases and hospitalizations.

“The first thing that would pop these numbers back up is if we came off universal masking in schools,” Beshear said at a news conference last month.

– Follow education reporter Aaron Mudd on Twitter @NewsByAaron or visit bgdailynews.com.


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