Friday, November 20, 2020
Health

The Latest: Pfizer, BioNTech seek emergency vaccine approval

The Latest: Pfizer, BioNTech seek emergency vaccine approval
0views


Health and Human Services Secretary Alex Azar said the companies would seek an emergency use authorization Friday from the Food and Drug Administration. The application and clinical trial data will be reviewed by an independent board of scientists before approval is granted.

Azar says: “Hope and help are on the way.”

This week the companies said their vaccine was 95% effective.

Moderna is expected to file for emergency approval for its own vaccine candidate in the coming weeks.

———

HERE’S WHAT YOU NEED TO KNOW ABOUT THE VIRUS OUTBREAK:

— CDC urges Americans to avoid travel at Thanksgiving

— Oxford and AstraZeneca expect results on vaccine candidate by Christmas

— African hits 2 million confirmed coronavirus cases

— More Americans waiting for hours in long lines to get tested for the coronavirus, as U.S. cases surge nationwide and families hope to gather safely for the holidays.

— Lawyers for the estates of dead workers allege top official at Tyson Foods’ largest pork plant created a pool for managers in Iowa to bet on how many workers would get infected.

— The NFL is placing all teams in intensive protocol starting Saturday to help lower the risk of spreading the coronavirus.

———

Follow AP’s coverage at https://apnews.com/hub/coronavirus-pandemic and https://apnews.com/UnderstandingtheOutbreak

———

HERE’S WHAT ELSE IS HAPPENING:

WASHINGTON — Vice President Mike Pence has concluded the White House’s first coronavirus task force briefing in months without taking questions or urging Americans not to travel at Thanksgiving as the virus rages.

Pence walked out Thursday and ignored shouted questions as to whether he acknowledged the election result and about whether not cooperating with the transition was endangering American lives by not delivering vital vaccine information to President-elect Joe Biden’s incoming administration.

Though the officials urged Americans to follow social distancing guidelines, they predominantly painted an optimistic portrait of the nation’s response to the pandemic, particularly touting the progress made on a vaccine. That stood in stark contrast to a more somber assessment offered by Biden at his own briefing minutes earlier.

President Donald Trump, who has not conceded the election, was not in attendance, nor was task force member Dr. Scott Atlas, who has expressed skepticism about masks. Drs. Deborah Birx and Anthony Fauci returned to the White House podium for the first time in months.

———

WASHINGTON– Federal regulators have authorized emergency use of another COVID-19 treatment, the anti-inflammatory drug baricitinib, to be used in combination with a drug already used to treat severely ill, hospitalized patients.

The Food and Drug Administration on Thursday cleared the new use for Eli Lilly’s pill baricitinib plus remdesivir for hospitalized adults and children two years and older requiring oxygen or ventilation therapy.

Remdesivir is the first and only drug approved by FDA to treat COVID-19. The emergency clearance for baricitinib acts as a preliminary approval until more data is available showing the drug works for COVID-19.

The FDA said the drug combination appeared to reduce recovery time in hospitalized patients, compared to patients who received only remdesivir.

The agency said ongoing research will be needed to confirm the benefit.

Indianapolis-based Lilly already sells baricitinib as Olumiant to treat rheumatoid arthritis, the less common form of arthritis that occurs when the immune system attacks joints, causing inflammation. An overactive immune system also can lead to serious problems in coronavirus patients.

The FDA based its decision on a 1,000-patient study in which patients were randomly assigned to receive the drug combination– baricitinib plus remdesivir– or remdesivir plus a placebo.

———

BATON ROUGE, La. — Gov. John Bel Edwards sounded the alarm about the latest spike in Louisiana’s virus cases, saying at a grim news conference Thursday: “Make no mistake. Louisiana is in the third surge of this pandemic.”

The Democratic governor worried people will gather as usual in packed houses for the upcoming Thanksgiving holiday.

“If you’re planning on a Thanksgiving that looks like previous Thanksgivings, where you bring extended family and friends around a common dinner table, you’re making a mistake … We ought to love our loved ones enough to not want to expose them to the dangers of COVID,” Edwards said.

Edwards said he doesn’t intend to return Louisiana to a stay-at-home order but is willing to consider adding more restrictions. He and public health experts are warily watching the number of patients hospitalized with the COVID-19 disease caused by the coronavirus.

Hospitals aren’t overwhelmed yet, but Edwards has cautioned the current trajectory raises that risk. Joining him at Thursday’s briefing was Dr. Christopher Thomas, who works in the COVID-19 unit of Our Lady of the Lake Regional Medical Center in Baton Rouge.

Thomas described overworked hospital staff, some who have left the profession amid the pandemic. He said Louisiana can’t request additional health care workers from other states — like it did to help hospitals in previous surges — because nearly all states are struggling with overwhelmed resources.

———

WASHINGTON — Infection disease expert Dr. Anthony Fauci says “wants to settle” concerns about a coronavirus vaccine as he returns to the White House podium for the first time in months.

Fauci says the Food and Drug Administration will thoroughly study the data before it approves any emergency use of a vaccine and he wants to “put to rest any concept that this was rushed in an inappropriate way. This is really solid.”

Fauci says that while “help is on the way” with a vaccine, it’s time for the American people to wear a mask, avoid crowds and do things as much as possible outdoors rather than indoors.

Fauci is speaking as members of the White House coronavirus task force address concerns about a surge in positive COVID-19 cases around the country, leading to a spike in hospitalizations and more deaths.

———

COLUMBUS, Ohio – Republican Gov. Mike DeWine was unsuccessful in convincing lawmakers to not pass legislation that would limit the powers of his administration and health officials as the virus’ spread across Ohio reached new peaks.

The governor promised to veto the bill, saying he has a “moral obligation” to do so. The House would need 60 votes to override a governor’s veto.

DeWine also designated one of the state’s most populous areas, Franklin County, home to Columbus, as a purple zone on the state’s color-coded alert system.

The designation is the highest on the state’s system and indicates the area was flagged for hitting six indicators, including sustained increases in cases and in coronavirus-related hospital admissions.

———

BRUSSELS — The European Union’s top official said Thursday that two COVID-19 vaccines could receive conditional market authorization as early as the second half of December.

Speaking after a meeting of EU leaders, European Commission president Ursula von der Leyen said the vaccines developed by Moderna and Pfizer, which created its serum with German drugmaker BioNTech, could be approved by the end of the year by the European Medicines Agency (EMA) “if all proceeds now without any problem.” Von der Leyen added “this is the very first step to be able to be on the market.”

Von der Leyen said the EMA is in constant contact with the FDA to synchronize the assessment of the vaccines. The European commission has sealed deals with several pharmaceutical companies including BioNTech and Pfizer to buy millions of doses of vaccines on behalf of all EU Member States. Von der Leyen said earlier this week the commission hopes a deal with Moderna will be soon finalized.

———

ST. PETERSBURG, Fla. — Florida reported more than 9,000 new daily coronavirus cases Thursday and at least 81 more deaths.

The numbers were released from the Florida Department of Health. Nearly 2,000 of the new cases were in Miami-Dade County, which has been the state’s biggest hotspot since March.

Over the past week, Florida averaged more than 7,080 newly reported cases per day, an increase from about 2,250 at the start of October.

The seven-day average of reported deaths is about 64, up from 54 a week earlier. That compares to a peak of 185 in early August. At least 18,030 people have died of COVID-19 in Florida since March.

Republican Gov. Ron DeSantis issued a video statement Thursday, the first time he’s publicly discussed the pandemic in a few weeks. He said he’s met with Trump administration officials and hospital CEOs regarding a vaccine, and that Florida has already bought 5 million needles, syringes and alcohol swabs that will be used to administer the vaccines.

Potential vaccines are still in the trial phase and have not been approved. They must be safe and effective before approval for use by the U.S. Food and Drug Administration.

———

WASHINGTON — Vice President Mike Pence is offering an upbeat assessment of the status of the coronavirus in the U.S., despite a surge in cases, hospitalizations and more than a quarter of a million deaths.

Pence says President Donald Trump directed that Thursday’s briefing be held.

Pence is making his first appearance at the White House podium in many weeks in his role as head of the White House coronavirus task force.

Trump, himself, has been silent on the recent spread of the virus after falsely saying during the campaign that “we are rounding the turn” and that the virus would be little discussed after the Nov. 3 election.

Pence says America “has never been more prepared to combat this virus than we are today.”

———

CONCORD, N.H. — With the coronavirus pandemic intensifying, New Hampshire on Thursday joined three dozen other states in enacting a statewide mask mandate.

Republican Gov. Chris Sununu issued an executive order requiring masks to be worn in public spaces, indoors or outside, when social distancing isn’t possible.

Previously, masks were required for certain people, including restaurant and retail workers with direct interaction with customers and those attending gatherings of more than 100 people.

Sununu had resisted calls for a statewide mandate, even as surrounding states enacted similar measures. But said on Thursday that it was appropriate given a recent surge in cases, hospitalizations and outbreaks.

More than 15,000 people have been diagnosed with COVID-19 in New Hampshire since the start of the pandemic, including 529 new cases announced Thursday. Two new deaths were announced, bringing the total to 506.

———

PROVIDENCE, R.I. — Rhode Island’s governor says the state’s economy will go on a “two-week pause” the day after Thanksgiving in an effort to slow soaring coronavirus infection rates.

Democratic Gov. Gina Raimondo says some businesses will be required to close and capacity at restaurants and houses of worship will be reduced starting Nov. 30. She says officials will reevaluate COVID-19 caseloads on Dec. 13, and if they haven’t eased, what she described as “a full state lockdown” will follow.

Raimondo also asked people to celebrate Thanksgiving only with members in their immediate household — even if that’s just dinner for one or a couple.

Rhode Island has reported nearly 47,000 confirmed cases and just under 1,300 deaths. Raimondo says hospitals are at 97% capacity.

———

LUBBOCK, Texas — Republican Gov. Greg Abbott is ruling out another shutdown in Texas as cases soar and thousands of additional medical workers are rushed to overworked hospitals struggling to keep up.

Abbott said Thursday there is an “overestimation” of what shutdowns achieve and claimed that local leaders asking for stricter measures weren’t doing enough to enforce rules already in place. Abbott imposed a partial shutdown in Texas this summer during a similar surge but now says lockdowns don’t work, pointing to spread outside workplaces and businesses.

Abbott’s stance comes as other governors across the U.S. are retreating to lockdown measures as cases rise nationwide. The virus is blamed for more than 20,000 deaths in Texas, the second-most in the nation, and Texas hospitals are on the brink of surpassing 8,000 virus patients for the first time since summer.

Texas has deployed more than 5,400 additional medical staff, including doctors and nurse, to overworked hospitals across Texas — more than at any point in the pandemic.

———

BATON ROUGE, La. — The White House’s coronavirus advisers are urging Louisiana to step up its restrictions to combat the spread of COVID-19, as the number of hospitalized virus patients in the state edged higher Thursday amid a third wave of infections.

Democratic Gov. John Bel Edwards continued to sound the alarm about the latest spike in virus cases, worrying that people won’t take precautions and will gather as usual in packed houses for Thanksgiving.

In its weekly report to states, the White House coronavirus task force said Louisiana’s efforts are currently “inadequate” and “must be increased.”

Hospitalizations reached 929 on Thursday, and have jumped by 250 over the last week and by 43 overnight, according to the Louisiana Department of Health. Hospitals aren’t overwhelmed yet, but Edwards has cautioned the current trajectory raises that risk. At least 5,951 people in Louisiana have died of COVID-19 since the pandemic began.

———

OMAHA, Neb. — A prominent Nebraska infectious disease expert sounded the alarm Thursday about the state’s surging coronavirus cases and called for a statewide mask mandate, a step Republican Gov. Pete Ricketts has repeatedly refused to take.

Dr. James Lawler, an infectious disease specialist at the University of Nebraska Medical Center, said the pandemic has reached its most dangerous point since it began and described the recent increase in virus hospitalizations as unsustainable.

Nebraska hospitals are straining to cope with the spike in coronavirus patients, and officials are urging the public to wear masks and take other precautionary steps to slow the spread of the disease. The virus has been surging in Nebraska, with more than five times as many COVID-19 hospitalizations as of Wednesday than the 185 it had two months ago.

———

DES MOINES, Iowa — Gov. Kim Reynolds announced she will provide $14 million in federal funds to Iowa’s long-term care centers to help them manage new outbreaks of the coronavirus at the facilities.

The federal virus relief money Reynolds announced Thursday will pay for additional testing and staffing at the long-term care centers, and it comes at a time when she said another 20 facilities are dealing with COVID-19 outbreaks. That means about a quarter of the state’s care homes now have outbreaks.

Infections at care centers can be especially devastating because older people are especially at risk of becoming seriously ill or dying of COVID-19. Reynolds noted that 74% of the people now being treated in hospitals for the virus are older than 60.

Iowa has had about 199,000 confirmed COVID-19 cases, including about 2,100 deaths since the pandemic started in March, officials said. In the last seven days, one of every 109 people in Iowa was diagnosed with COVID-19. Iowa has the nation’s third-highest number of new virus cases per capita in the past 14 days, according to data from Johns Hopkins University.

———

NEW YORK — The nation’s top public health agency is urging Americans not to travel for Thanksgiving.

The Centers for Disease Control and Prevention on Thursday recommended spending the holiday with people in the same household. The advice comes as coronavirus infections, hospitalizations, and deaths are surging across the country.

The CDC’s Dr. Erin Sauber-Schatz cited more than 1 million new cases in the U.S. in the past week for the new guidance.

The CDC says hosting families should take added precautions if they include returning college students, military service members or others in a gathering. That means keeping 6 feet apart, wearing masks and one person serving the food. It recommends eating outdoors, if possible.

CDC scientists believe about 40% of infected people don’t have obvious symptoms but can still spread the virus.

The U.S. leads the world with 11.6 million cases and 251,000 deaths from the coronavirus.

———

MILAN — Italy registered 36,176 new coronavirus cases on Thursday.

The Health Ministry Statistics says more than 250,000 tests were conducted, for a positivity rate of more than 14%.

There were 653 confirmed deaths, a slight decrease from more than 700 in recent days.

Infections continued to rise two weeks into a partial lockdown on hard-hit regions and a nationwide curfew. Officials are particularly concerned about hospitals, which added 106 new patients to reach 33,610. More than half of the country’s hospital beds are dedicated to treating COVID-19 patients.

Italy has reported 1.2 million cases and the confirmed death toll stands at 47,870, second to Britain in Europe.

———

MADRID — Spain is making slow progress to contain a resurgence of the coronavirus pandemic.

Health authorities say the 14-day cumulative number of COVID-19 cases per 100,000 people stands at 436. A week ago, it was 504.

Emergency response chief Fernando Simón says the rate “is falling, but the numbers are still very high.”

He said COVID-19 patients are taking more than 30% of ICU beds, far lower than the peak levels seen last spring.

The Spanish Health Ministry reports 1.54 million total confirmed cases and nearly 42,300 deaths.



Source link

Leave a Response