Emergent : QC Systems Detected Single Failed Covid-19 Vaccine Batch

Johnson & Johnson Covid-19 vaccine contract manufacturer Emergent BioSolutions Inc. said its quality checks had worked, detecting a batch of vaccines that didn't meet standards.

"Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process," the company said in a statement Thursday.

Emergent BioSolutions didn't specify the number of doses affected or what had happened, but The Wall Street Journal, citing anonymous sources, reported that the batch was contaminated.

One of those people, The Journal reported, estimated the error at the Baltimore plant affected approximately 15 million doses of the vaccine's main ingredient.

J&J, which also didn't discuss what had happened, said it would be able to make enough doses to meet production targets for the U.S. in the coming months. J&J's plant in the Netherlands has been making the main ingredient for the initial U.S. supply of its vaccine, including the nearly four million doses that were distributed immediately after it was authorized in late February.

Emergent also makes at the same plant the main ingredient for AstraZeneca PLC's Covid-19 vaccine, which hasn't been authorized for use in the U.S.

https://www.marketscreener.com/quote/stock/EMERGENT-BIOSOLUTIONS-INC-36547/news/Emergent-BioSolutions-nbsp-Quality-Control-Systems-Worked-to-Detect-Single-Covid-19-Vaccine-Batch-32867177/

FDA Probes Cause of Failed Johnson & Johnson Covid-19 Vaccine Batch

 The Food and Drug Administration is investigating what caused a batch of the active ingredient for Johnson & Johnson's Covid-19 vaccine to be scrapped for failing to meet quality standards at a contract manufacturing plant, according to a person familiar with the matter.

The FDA may send an inspection team to assess the situation at the Baltimore plant operated by contractor Emergent BioSolutions Inc., the person said.

The regulatory scrutiny follows J&J's disclosure Wednesday that a batch of the main ingredient for its Covid-19 vaccine manufactured at the Emergent plant didn't meet standards. The batch didn't reach the vial-filling and finishing stage, and no doses from it were distributed.

J&J says the quality lapse didn't affect vaccine doses that have been distributed in the U.S. since the vaccine was authorized in late February, and the company still has enough supply to meet near-term commitments. J&J also makes the main ingredient for the vaccine at its own plant in the Netherlands.

Emergent BioSolutions, of Gaithersburg, Md., said in a statement Thursday that it isolated the batch of vaccine ingredients because it didn't meet specifications and quality standards. Emergent said it would dispose of the batch properly.

The company said that discarding a batch is disappointing but occasionally happens during the complex vaccine manufacturing process.

The White House said Thursday it didn't expect the issue to affect the promised U.S. supply of J&J's vaccine. J&J expects to deliver about 100 million doses for use in the U.S. by midyear, under the terms of a $1 billion purchase agreement with the federal government.

"We have been assured that they expect to meet those deadlines," White House press secretary Jen Psaki said at a briefing.

Ms. Psaki said "the issue was identified as part of rigorous quality control system checks," and the Department of Health and Human Services notified the White House late last week.

Asked if the White House should have revealed the problem publicly earlier, Ms. Psaki said the plant hasn't yet been FDA-approved. "This is probably the process of working as it should," she said. Drug plants can manufacture ingredients for a drug or vaccine but finished products can't be released until the FDA authorizes them.

J&J's vaccine is the third to be authorized in the U.S., after shots from Pfizer Inc. with its partner BioNTech SE, and Moderna Inc. Health authorities have been counting on the arrival of the single-shot J&J vaccine to boost the overall supply of shots and to simplify vaccinations because it doesn't require a second dose.

Emergent said that it was confident in its ability to meet FDA requirements.

Emergent makes the main ingredient for AstraZeneca PLC's Covid-19 vaccine at the same plant, though that vaccine isn't authorized for use in the U.S. An AstraZeneca spokeswoman said the company was "aware of the reports regarding the facility and we understand Emergent is investigating the matter."

Emergent Chief Executive Robert Kramer told CNBC Thursday "it wasn't the case where an ingredient from one vaccine contaminated or impacted the other." He said the J&J batch didn't meet quality specifications but he didn't elaborate on what happened.

Vaccine manufacturing experts say the issues at the Emergent plant have to be addressed, but the detection of the problem before doses from the batch were released was an encouraging sign.

"It's definitely alarming but it also shows that this is a system that eventually works," said Tinglong Dai, associate professor of operations management and business analytics at Johns Hopkins University's Carey Business School, who has researched the vaccine supply chain. "I have high confidence in the error detection part."

J&J said it was sending additional experts in manufacturing, technical operations and quality to be on-site at Emergent to oversee all manufacturing of the J&J vaccine there.

https://www.marketscreener.com/quote/stock/JOHNSON-JOHNSON-4832/news/FDA-Probes-Cause-of-Failed-Johnson-Johnson-Covid-19-Vaccine-Batch-32867447/

China Sinovac: Reached 2B doses annual capacity for COVID-19 vaccine

 

China's Sinovac Biotech said on Friday its third production plant for its COVID-19 vaccine was ready and had started manufacturing procedures for bulk vaccine ingredient, doubling its annual capacity to 2 billion doses.

A Sinovac spokesman said the third facility, in Beijing, had started cultivating cells where the coronavirus would be grown, a procedure that could take a relatively long time.

Sinovac did not say when it will actually produce 2 billion doses of the vaccine.

More than 200 million doses of Sinovac's vaccine named CoronaVac have been delivered globally, up from 160 million doses announced on March 22.

The firm said it estimated over 100 million doses have been administered worldwide.

https://www.marketscreener.com/quote/stock/SINOVAC-BIOTECH-LTD-5714593/news/Sinovac-Biotech-nbsp-China-Sinovac-says-it-reached-two-billion-doses-annual-capacity-for-COVID-19-32868005/

Opposition grows against UK vaccine passports

 More than 70 British lawmakers have signalled their opposition to the introduction of so-called vaccine passports that the government is considering bringing in to help to open the economy as it starts lifting COVID-19 lockdown restrictions.

The government is reviewing the idea of asking people to show proof of a COVID-19 vaccination to access crowded spaces such as pubs or sports events, with Prime Minister Boris Johnson having already said that a certificate is likely to be needed for international travel.

The Daily Telegraph newspaper reported on Saturday that trials of COVID passports would begin within weeks during pilots at major sports events and possibly a music awards ceremony in the next two months to assess their impact.

On Friday Johnson said that a combination of immunity factors - if people have had the disease, a vaccination or had a COVID-19 test - would give businesses confidence.

“So those three things working together will, I think, be useful for us as we as we go forward,” Johnson said.

But there has been mounting concern from some in his own Conservative Party, as well as opposition lawmakers and civil rights groups, about the prospect of vaccine certificates.

“We oppose the divisive and discriminatory use of COVID status certification to deny individuals access to general services, businesses or jobs,” said a statement signed by a group of more than 70 lawmakers from across the political spectrum.

Under the government’s planned “roadmap” out of the pandemic, pubs will be allowed to serve people outdoors later this month, with a further easing of restrictions in mid-May before all measures are lifted near the end of June.

Johnson suggested last month that some pubs might require customers to produce vaccine certificates. Culture minister Oliver Dowden, meanwhile, has said that such certificates could help get more people into theatres.

No decision has yet been made and Johnson has instructed senior minister Michael Gove to review the possible role of certificates, saying there are deep and complex ethical issues to explore. Gove is due to report back shortly.

More than 31 million Britons have already received their first vaccine dose in the fastest inoculation programme in Europe.

https://www.reuters.com/article/us-health-coronavirus-britain-vaccinepas/opposition-grows-against-uk-vaccine-passports-idUSKBN2BP0H1

Fauci: U.S. may not need AstraZeneca COVID-19 vaccine

 The United States may not need AstraZeneca’s COVID-19 vaccine, even if it wins U.S. regulatory approval, Anthony Fauci, the nation’s top infectious disease doctor told Reuters on Thursday.

The vaccine, once hailed as another milestone in the fight against the COVID-19 pandemic, has been dogged by questions since late last year, even as it has been authorized for use by dozens of countries, not including United States.

Fauci, director of the National Institute of Allergy and Infectious Diseases and chief medical adviser to the White House, said the United States has enough contracts with other vaccine makers to vaccinate its entire population, and possibly enough for booster shots in the fall.

Asked whether the United States will use the AstraZeneca vaccine doses, he said, “That’s still up in the air. My general feeling is that given the contractual relationships that we have with a number of companies, that we have enough vaccine to fulfill all of our needs without invoking AstraZeneca.”

Late last year, the drugmaker and Oxford University published data from an earlier trial with two different efficacy readings as a result of a dosing error. Then in March, more than a dozen countries temporarily suspended the use of AstraZeneca’s vaccine after reports linked it to a rare blood clotting disorder.

Also in March, a U.S. health agency said data from the company gave an incomplete picture of its efficacy. Days later AstraZeneca published results showing diminished, though still strong, efficacy.

Fauci said that “If you look at the numbers (of doses) that we’re going to be getting, the amount that you can get from J&J, from Novavax from Moderna if we contract for more, it is likely that we can handle any boost that we need, but I can’t say definitely for sure.”

https://www.reuters.com/article/us-health-coronavirus-astrazeneca-exclus/exclusive-fauci-says-u-s-may-not-need-astrazeneca-covid-19-vaccine-idUSKBN2BO6XS

Aveanna Health files for $100M IPO

 We are a leading, diversified home care platform focused on providing care to medically complex, high-cost patient populations. We directly address the most pressing challenges facing the U.S. healthcare system by providing safe, high-quality care in the home, the lower cost care setting preferred by patients. Our patient-centered care delivery platform is designed to improve the quality of care our patients receive, which allows them to remain in their homes and minimizes the overutilization of high-cost care settings such as hospitals. Our clinical model is led by our caregivers, primarily skilled nurses, who provide specialized care to address the complex needs of each patient we serve across the full range of patient populations: newborns, children, adults and seniors. We have invested significantly in our platform to bring together best-in-class talent at all levels of the organization and support such talent with industry leading training, clinical programs, infrastructure and technology-enabled systems, which are increasingly essential in an evolving healthcare industry. We believe our platform creates sustainable competitive advantages that support our ability to continue driving rapid growth, both organically and through acquisitions, and positions us as the partner of choice for the patients we serve.

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IPO File Date	04/01/2021
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Offer Shares (mm)	n/a
Deal Size ($mm)	$100
Lock-Up Date	IPO Pro Only
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Headquarters	Atlanta, GA
Founded	2016
Employees	42,000
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Home Oxygen Program Helped COVID Pneumonia Patients

 Few COVID-19 patients in Los Angeles with pneumonia discharged on a practice of home oxygen use died or had to be readmitted to the hospital within 30 days, researchers found.

Among 621 patients discharged from either the hospital or the emergency department, the all-cause mortality rate was 1.3% (95% CI 0.6%-2.5%) and the 30-day all-cause hospital readmission rate was 8.5% (95% CI 6.2%-10.7%), reported Brad Spellberg, MD, of Los Angeles County/University of Southern California Medical Center, and colleagues, writing in JAMA Network Open.

They developed the SAFE @ HOME O2 Expected Practice, which stated that clinically stable patients with COVID-19 pneumonia requiring at least 3 L per minute of nasal cannula oxygen to achieve at least 92% oxygen saturation should be discharged to be treated in an ambulatory setting. Patients were dispensed the necessary equipment for home monitoring, such as a pulse oximeter, oxygen tank, and concentrator.

This practice also required patients discharged with oxygen to be called by a nurse, with physician support if necessary, within the first 12-18 hours after discharge. Calls were performed daily, 7 days a week, until patients showed that they understood both how to use the equipment and the indications for return care.

Spellberg and colleagues examined data from 621 patients with COVID-19 pneumonia from March 20 to August 19, 2020. Patients received either inpatient or emergency department care at two large urban medical centers, and were discharged with home oxygen.

Participants' median age was 51, two-thirds were men, and three-quarters were discharged from inpatient admissions. About three-quarters were insured by Medicaid, and about 85% spoke Spanish. Median follow-up was 26 days.

No patients died at home or during transport to acute care.

In addition, while a formal cohort analysis was not performed, hospital mortality for readmitted patients after a trial of home oxygen was "consistent with overall observed hospital mortality" for patients without a preceding or subsequent trial of home oxygen (15% vs 14%, respectively), the researchers said.

Limitations to the data, the team noted, include the observational nature and limited generalizability, as comparable data on acute care duration and patients not discharged and not requiring home oxygen was unavailable.

The authors concluded that this program "may be considered part of a strategy to ensure right care, right place, and right time for patients with COVID-19 pneumonia, and to preserve acute care access during the pandemic," and that the results underscore the program's safety.

Disclosures

The authors disclosed no conflicts of interest.

Primary Source

JAMA Network Open

Source Reference: Banerjee J, et al "Mortality and Readmission Rates Among Patients With COVID-19 After Discharge From Acute Care Setting With Supplemental Oxygen" JAMA Netw Open 2021; DOI: 10.1001/jamanetworkopen.2021.3990.

https://www.medpagetoday.com/infectiousdisease/covid19/91903