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Business

Sanofi to help produce 100 million Pfizer/BioNTech vaccine doses

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The French company will aim to help supply more than 100 million doses of the vaccine this year from its German plant in Frankfurt, CEO Paul Hudson told Le Figaro newspaper on Tuesday.

Pfizer and its German partner BioNTech are, like other Covid-19 vaccine manufacturers such as AstraZeneca, struggling to meet the huge demand for shots that are the world’s best bet for overcoming the pandemic.

Last month, Sanofi and Britain’s GlaxoSmithKline said a Covid-19 vaccine they are jointly developing had showed an insufficient immune response in older people, delaying its launch to late this year.

The company has been under pressure since to seek ways of helping with Covid-19 vaccines devised by other drugmakers as the pandemic intensifies again in Europe and elsewhere.

“Since our main vaccine is a few months late, we asked ourselves how we could be of assistance now,” Hudson was quoted as saying.

Sanofi is also working on another Covid-19 vaccine candidate with U.S. firm Translate Bio which uses mRNA technology, similar to the approach of Pfizer/BioNTech. Phase I trials are expected to start this quarter.

Hudson confirmed in the interview that Sanofi remains committed to its two vaccines projects.

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Health

N.J. reports 3,694 new COVID cases, 21 more deaths. Vaccinations surpass 565K doses.

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New Jersey health officials on Monday reported another 3,694 confirmed cases of the coronavirus and 21 additional deaths as total vaccinations in the state surpassed 565,000.

The seven-day average for new confirmed positive test is 4,365, down 15% from a week ago, and down 5% from a month ago.

“We are averaging approximately 25,000 vaccinations per day,” Gov. Phil Murphy announced the update at his latest coronavirus briefing in Trenton. He noted that vaccine supplies from the federal government remains limited. “We know there is far more demand for vaccines.”

New Jersey launched a hotline on Monday morning to schedule vaccinations for those who are eligible – 855-568-0545. More than 58,000 calls were received by noon, health officials said.

“Right now very limited appointments are available,” said Health Commissioner Judith Persichilli.

Statewide hospitalizations for confirmed or suspected coronavirus cases increased to 3,238 as of Sunday night, but that’s still down 16% from a recent peak on Dec. 22.

The statewide rate of transmission decreased to 0.94, from 0.97. Any number above 1 means the outbreak is growing.

The positivity rate for tests on Thursday, the most recent day available, was 9.62% for 54,987 tests.

Health officials announced Friday that New Jersey has recorded its first two cases of the highly contagious COVID-19 variant first identified in the U.K.

New Jersey has now reported 598,660 confirmed COVID-19 cases in the nearly 11 months since its first positive test March 4. Another 68,291 cases from antibody tests have been reported, though those are considered probable and may overlap with the confirmed tests.

The state of 9 million residents has reported 20,972 deaths related to the virus in that time — 18,851 confirmed and 21 considered probable fatalities. New Jersey has reported 1,869 deaths in January.

Deaths from the coronavirus in New Jersey surpassed what is typically recorded for heart disease and cancer, the two leading killers year after year.

CORONAVIRUS RESOURCES: Live map tracker | Newsletter | Homepage

VACCINATIONS

There have been 565,401 coronavirus vaccine doses administered in New Jersey so far, according to the state’s dashboard. Of those, 492,260 were the first of two doses people will receive.

That’s out of nearly 1 million doses the state has received from the federal government, according to a running tally by the federal Centers for Disease Control.

All six of the state’s vaccine mega-sites have opened.

New Jersey has faced criticism for having a slower rollout than dozens of other states as it continues to deal with a second wave of the pandemic, according to data from the CDC.

Officials stress that the state is depending on the federal government for its supply and is receiving only 100,000 doses a week, though New Jersey has the capacity for 470,000 a day.

VACCINATIONS BY COUNTY:

  • ATLANTIC COUNTY – 17,581 doses
  • BERGEN COUNTY – 62,161 doses
  • BURLINGTON COUNTY – 28,387 doses
  • CAMDEN COUNTY – 33,107 doses
  • CAPE MAY COUNTY – 8,254 doses
  • CUMBERLAND COUNTY – 8,444 doses
  • ESSEX COUNTY – 44,887 doses
  • GLOUCESTER COUNTY – 20,255 doses
  • HUDSON COUNTY – 25,939 doses
  • HUNTERDON COUNTY – 8,575 doses
  • MERCER COUNTY – 14,046 doses
  • MIDDLESEX COUNTY – 41,798 doses
  • MONMOUTH COUNTY – 42,718 doses
  • MORRIS COUNTY – 39,910 doses
  • OCEAN COUNTY – 33,855 doses
  • PASSAIC COUNTY – 26,420 doses
  • SALEM COUNTY – 3,070 doses
  • SOMERSET COUNTY – 22,768 doses
  • SUSSEX COUNTY – 9,059 doses
  • UNION COUNTY – 27,318 doses
  • WARREN COUNTY – 5,612 doses
  • OUT OF STATE – 23,169 doses
  • UNKNOWN COUNTY – 18,068 doses

COUNTY-BY-COUNTY NUMBERS (sorted by most new cases)

  • Middlesex County: 57,137 confirmed cases (414 new), 1,651 confirmed deaths (217 probable)
  • Monmouth County: 42,611 confirmed cases (350 new), 1,107 confirmed deaths (104 probable)
  • Hudson County: 54,604 confirmed cases (343 new), 1,659 confirmed deaths (172 probable)
  • Ocean County: 42,613 confirmed cases (323 new), 1,513 confirmed deaths (90 probable)
  • Bergen County: 57,844 confirmed cases (309 new), 2,167 confirmed deaths (268 probable)
  • Essex County: 57,474 confirmed cases (309 new), 2,247 confirmed deaths (260 probable)
  • Camden County: 35,300 confirmed cases (205 new), 911 confirmed deaths (67 probable)
  • Union County: 43,358 confirmed cases (196 new), 1,457 confirmed deaths (189 probable)
  • Morris County: 26,200 confirmed cases (193 new), 833 confirmed deaths (202 probable)
  • Passaic County: 45,855 confirmed cases (174 new), 1,407 confirmed deaths (160 probable)
  • Burlington County: 26,987 confirmed cases (163 new), 628 confirmed deaths (51 probable)
  • Atlantic County: 16,438 confirmed cases (128 new), 427 confirmed deaths (23 probable)
  • Mercer County: 22,889 confirmed cases (114 new), 751 confirmed deaths (39 probable)
  • Gloucester County: 18,328 confirmed cases (101 new), 458 confirmed deaths (22 probable)
  • Somerset County: 15,719 confirmed cases (85 new), 631 confirmed deaths (93 probable)
  • Sussex County: 6,574 confirmed cases (73 new), 198 confirmed deaths (53 probable)
  • Cumberland County: 10,321 confirmed cases (72 new), 274 confirmed deaths (13 probable)
  • Hunterdon County: 5,117 confirmed cases (42 new), 92 confirmed deaths (54 probable)
  • Warren County: 5,219 confirmed cases (40 new), 179 confirmed deaths (15 probable)
  • Salem County: 3,746 confirmed cases (20 new), 122 confirmed deaths (9 probable)
  • Cape May County: 3,082 confirmed cases (18 new), 139 confirmed deaths (20 probable)

HOSPITALIZATIONS

The 3,238 patients hospitalized with confirmed (3,017) or suspected (221) COVID-19 cases across New Jersey’s 71 hospitals as of Sunday night were 17 more than the previous night.

That included 596 in critical or intensive care (five fewer than the previous night), with 390 on ventilators (nine more).

There were also 240 COVID-19 patients discharged Sunday, according to the state’s COVID-19 dashboard.

The governor has said any hospitalizations over 5,000 patients would likely trigger new rounds of restrictions. But the number of people being hospitalized has mostly ticked down slowly in recent days after hitting a more than seven-month high of 3,873 people on Dec. 22.

SCHOOL CASES

At least 597 students and staff in 121 school districts in New Jersey have caught COVID-19 through in-school outbreaks, according to the latest update from state health officials.

That’s an increase of 10 districts and 40 cases from the previous weekly report. There are now confirmed in-school outbreaks in all 21 counties, though the state does not identify the individual school districts.

Those numbers do not include students or staff believed to have been infected outside school or cases that can’t be confirmed as in-school outbreaks. Though the numbers keep rising every week, Murphy has said the school outbreak statistics remain below what state officials were expecting when schools reopened for in-person classes.

New Jersey defines school outbreaks as cases where contact tracers determined two or more students or school staff caught or transmitted COVID-19 in the classroom or during academic activities at school.

AGE BREAKDOWN

Broken down by age, those 30 to 49 years old make up the largest percentage of New Jersey residents who have caught the virus (31.2%), followed by those 50-64 (23.7%), 18-29 (19.3%), 65-79 (11.1%), 5-17 (7.5%), 80 and older (5.4%), and 0-4 (1.6%).

On average, the virus has been more deadly for older residents, especially those with preexisting conditions. Nearly half the state’s COVID-19 deaths have been among residents 80 and older (47%), followed by those 65-79 (33%), 50-64 (15.6%), 30-49 (4%), 18-29 (0.4%), 5-17 (0%), and 0-4 (0%).

At least 7,698 of the state’s COVID-19 deaths have been among residents and staff members at nursing homes and other long-term care facilities. That number has been rising again at a steeper rate in recent months, with deaths at the state’s nursing homes nearly tripling in December.

There are currently active outbreaks at 427 facilities, resulting in 6,994 active cases among residents and 7,675 among staffers.

GLOBAL NUMBERS

As of Monday afternoon, there have been more than 99.3 million positive COVID-19 tests across the world, according to a running tally by Johns Hopkins University. More than 2.13 million people have died from coronavirus-related complications.

The U.S. has reported the most cases, at more than 25.1 million, and the most deaths, at more than 419,000.

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Matt Arco may be reached at marco@njadvancemedia.com.

Brent Johnson may be reached at bjohnson@njadvancemedia.com.



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Health

Bay Area hospital won’t receive COVID vaccine after teachers given doses before frontliners, elderly

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On Thursday, teachers and staff at Los Gatos Union School District received a tantalizing offer in their emails: A COVID-19 vaccine ahead of schedule.

According to investigative news outlet San Jose Spotlight, Good Samaritan Hospital in Los Gatos offered district Superintendent Paul Johnson and staff the vaccine as a “gesture” of kindness after the district raised funds for a program to provide frontline workers meals.

“The COO of the hospital says we can access the appointments … and has cleared [Los Gatos schools] staff to sign up under the healthcare buttons,” a letter from Johnson to district staff read. Educators are part of Phase 1B in California and Santa Clara County, behind frontline staff, nursing home residents and those 65 and older.


Teachers, per the email, were told to impersonate healthcare workers — with the approval of COO Gary Purushotham, despite the threat of perjury — in order to obtain access to the vaccine. “Remember to register under healthcare initially,” Johnson’s note read.

The district did not immediately respond to a request for comment from SFGATE.

Now, Santa Clara County is withholding vaccines from the hospital after the offer was extended and an estimated 65 doses were offered to district teachers and staffers.

Per a letter from the county obtained by SFGATE, Dr. Marty Fenstersheib, the county’s COVID-19 vaccine officer, said that the hospital’s actions “are inconsistent with both the letter and spirit” of California’s vaccine protocol. It also created confusion, he alleged, “causing other educators to understandably but incorrectly expect” vaccinations.

Santa Clara County will provide second doses for those who received their initial shot at Good Samaritan. But “any additional doses,” he warned, will be withheld “unless and until Good Samaritan provides sufficient assurances it will follow state and county direction on vaccine eligibility.”

Good Samaritan currently has just over 6,500 first and second vaccine doses, according to a county dashboard.

Fenstersheib also suggested that the vaccine was offered as something of a quid pro quo, rewarding “employees of a school district that had provided fundraising that assisted Good Samaritan employees, rather than prioritizing older educators or those from areas of the county with high prevalence of COVID-19.”

(In a follow-up email sent to teachers obtained by Spotlight, Johnson, the superintendent, denied any allegations of quid pro quo.)

Good Samaritan CEO Joe DeSchryver, in an apology posted Saturday in which he said the hospital was “in error,” explained that the decision to expand their vaccine distribution past state and county recommendations was done in order “to avoid wasting supply that was already thawed.”

But by that point, Spotlight reported, the hospital barely had sufficient doses for hospital workers, other frontliners and individuals 75 years or older.

“We are committed to working with the county on a plan to assure we have clarity and are adhering to the state and county guidelines on vaccine eligibility, which we have done so prior to this incident,” DeSchryver added. “Additionally, we are reviewing our processes and systems to ensure this does not happen again.”

The hospital did not immediately respond to a request for comment from SFGATE.

As of Monday, California has dispensed over 2.3 million vaccines — 47% of its currently available doses.



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US

COVID NY Update: State runs out of COVID vaccine, using 2nd doses as 1st doses up to federal government, Cuomo says

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NEW YORK CITY (WABC) — Both New York City and New York state have run completely dry of covid vaccines with the next shipment not expected until early next week.

The news comes as more and more hospitals cancel vaccination appointments with no new appointments scheduled through Monday.

15 vaccine centers have also closed.

Gov. Andrew Cuomo is blaming the now-former Trump administration for opening up too many categories of eligibility, without increasing supply.

“It should have been opened as you had allocation. Anyway, that is not what we did, it’s not what they did. And now you have a period of confusion and anxiety because you’re trying to hit seven million people at 250,000 a week,” Cuomo said.

Another quarter-million doses will arrive in time for next week, but state officials say that’s far from enough.

Some have suggested using second doses, which are in storage, as first doses.

During a visit to a COVID-19 vaccine pop-up site at a NYCHA complex in Brooklyn Saturday, Cuomo said that would only be possible with collaboration from the federal government.

“The reason why the federal government has to agree is because they have to agree that they’re then going to send you enough second doses in the future. Otherwise, you want them giving people first dosages and then you don’t have a second dosage for them,” Cuomo said.

Health experts say administering the second dose of the vaccine within the timeframe outlined by federal guidelines is critical to ensuring long-term protection.

So far more than one million people in the state have gotten their first dose of the vaccine.

At a Friday briefing, Cuomo said deliveries of the week six allocations, about 250,400 doses, are on the way, but those deliveries “are delivered by the federal government by various means and they arrive at different times throughout the week.”

The state is able to administer about 80,000 doses per day and could easily do 100,000 per day, Cuomo said.

“The moment the vaccines arrive, our goal is to get them in arms as soon as possible. 250,400 doses per week is not enough,” Cuomo said.

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Health

Pfizer will now ship fewer COVID-19 vaccine vials to the US after scientists discovered extra doses in them

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Covid-19 vaccine vials. REUTERS/Dado Ruvic/Illustration

  • Pfizer will ship fewer COVID-19 vaccine vials to the US after extra doses were discovered.

  • The company has pushed the FDA to formally acknowledge the extra doses found in each vial.

  • Some pharmacists say they’re still struggling to extract the extra doses.

  • Visit Insider’s homepage for more stories.

Last month, pharmacists across the US found a pleasant surprise when they discovered that the vials of Pfizer’s COVID-19 vaccine contained extra doses.

As a result, Pfizer will now ship fewer vials of vaccine to the US to account for that, according to a New York Times report. The pharmaceutical company has committed to providing 200 million vaccine doses to the US by the end of July. The extra doses found in the initial allocations will now count toward that number.

Pfizer charges by the dose and for weeks has reportedly pushed officials at the US Food and Drug Administration to formally acknowledge that the vials contain six (and sometimes seven) doses, instead of five.

Earlier this month, the FDA obliged, changing the wording of the vaccine’s emergency use authorization, according to The Times. Pfizer officials argued the distinction was necessary, since the federal government’s contract required payment by the dose.

But some pharmacists say they’ve had challenges actually extracting those extra doses, because that process requires a special syringe.

“Now there’s more pressure to make sure that you get that sixth dose out,” Michael Ganio, the senior director for pharmacy practice and quality at the American Society of Health-System Pharmacists told The Times.

Pfizer’s chief executive, Dr. Albert Bourla, said that the extra sixth dose allows the company to extend its vaccine supply further. Pfizer had originally estimated it could manufacture 1.3 billion doses in 2021, but the discovery of the extra doses reportedly played a role in the company’s most recent estimate of two billion doses by the end of the year.

When pharmacists first discovered the extra doses, there was both excitement and confusion. Some even threw out the extra doses because they hadn’t been given permission to use them, according to the newspaper. But the FDA soon offered both permission and instruction for using the extra doses.

At the time, the extra doses seemed to suggest that instead of the 100 million doses Pfizer had originally promised the US by the end of March, the country could wind up with as many as 120 million, some good news amid the chaotic vaccine rollout, but Pfizer demanded that the extra doses instead be counted as part of its existing contract.

“Pfizer will make a lot of money from these vaccines, and the US government assumed a lot of the upfront risk in this case, so I’m not sure why Pfizer didn’t just continue to fill their supply as planned, even if it meant oversupplying a little,” Dr. Aaron S. Kesselheim, a professor of medicine at the Brigham and Women’s Hospital and Harvard Medical School told The Times.

After weeks of reported language dispute between Pfizer and the FDA, the agency formally changed the vaccine’s fact sheet to specify that six doses were included in each vial.

The number of Pfizer vaccines allocated to each state could be based on that new language starting as soon as next week, The Times reported.

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World

1,900 COVID vaccine doses ruined at Boston VA hospital after freezer accidentally unplugged

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Nearly 2,000 doses of a COVID-19 vaccine were spoiled at a Veterans Affairs hospital in Boston after a contractor accidentally unplugged a freezer, hospital officials announced Thursday. Staff at the Jamaica Plain VA Medical Center discovered on Tuesday that a freezer had failed, compromising 1,900 doses of the Moderna COVID-19 vaccine.

The plug to the freezer was found to be loose after a contractor accidentally unplugged it while cleaning, according to a statement from Kyle Toto, a spokesman for VA Boston Healthcare System. The freezer had been in a safe location and had an alarm system, he said.

Both Moderna and Pfizer-BioNTech’s vaccines require extremely cold temperatures for storage.  

“For the Moderna vaccine it’s 12 hours. Once it’s been at room temperature for longer than that you no longer can assure that it’s effective and so you can’t give the vaccine,” Dr. Paul Biddinger, the Medical Director for Emergency Preparedness at Mass General Brigham, told CBS Boston.

The system is investigating the cause of the incident and why the monitoring alarm system did not work. More doses are on the way, Toto said, and officials “do not foresee disruption” of the system’s vaccination effort.

Temperature issues have caused problems for vaccine rollouts in other states.

Nearly 12,000 Moderna doses that were being shipped to Michigan on Sunday were spoiled after getting too cold. In Wisconsin, a pharmacist faces charges after authorities say he deliberately ruined hundreds of doses by removing them from refrigeration for two nights.

The Moderna vaccine needs to be stored at regular freezer temperatures, but not the ultra-cold required for Pfizer-BioNTech’s shot.

CBS Boston reports Massachusetts Rep. Stephen Lynch said the doses have been moved to Brockton and West Roxbury while the cleanup operation is still ongoing.

“We simply believe it was an accident,” Lynch told reporters Friday. “Part of the contributing factor was the way these plugs operate. One of them is an offset, so it’s very difficult to pull out. But the one at the top of the freezer was a direct pull so the engineering staff here have corrected that. They’ve created a bracket, they’ve taken pictures of that plug and sent it around to all the other VA hospitals that have this thermo-scientific freezer so that in the event that might happen somewhere else.”

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Business

Texas doctor charged with stealing COVID-19 vaccine doses

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A Texas doctor has been charged with stealing nine doses of the coveted COVID-19 vaccine while working at a county vaccination site, prosecutors announced Thursday.

Dr. Hasan Gokal, who worked with the Harris County Public Health system, is accused of stealing a vial that contained the doses from a vaccination site in Humble on Dec. 29, Harris County District Attorney Kim Ogg said in a statement.

A week later, Gokal bragged about the theft to a co-worker, who then complained to his supervisors, Ogg said.

Gokal was later fired from his job.

Ogg said Gokal stole the doses to give them to his family and friends, leaving those who need a shot the most without one.

“He abused his position to place his friends and family in line in front of people who had gone through the lawful process to be there,” Ogg said of Gokal. “What he did was illegal and he’ll be held accountable under the law.”

Lawyer Paul Doyle defended his client arguing the vaccine would have expired anyway.

“Dr. Gokal is a dedicated public servant who ensured that COVID-19 vaccine dosages that would have otherwise expired went into the arms of people who met the criteria for receiving it,” Doyle said in a statement to KHOU11.

“Harris County would have preferred Dr. Gokal let the vaccines go to waste and are attempting to disparage this man’s reputation in the process to support this policy. We look forward to our day in court to right this wrong,” the lawyer continued.

Gokal faces up to a year in jail and a $4,000 fine.

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