WHO seeks 'additional clarifications' from Bharat Biotech for Covaxin

The World Health Organisation (WHO) on Tuesday said "additional clarifications" are needed from Bharat Biotech regarding its Covid-19 vaccine 'Covaxin' for a final "risk-benefit assessment" before recommending the vaccine for emergency use.

"The Technical Advisory Group for Emergency Use Listing (TAG-EUL) is an independent advisory group that provides recommendations to WHO on whether a Covid 19 vaccine can be listed for emergency use under the EUL procedure," the WHO statement report said.

"The TAG met today (October 26, 2021) and decided that additional clarifications from the manufacturer are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine," the WHO said.

The WHO said it expects to receive these clarifications from Bharat Biotech by the end of this week.

"The TAG expects to receive these clarifications from the manufacturer by the end of this week, and aims to reconvene for the final risk-benefit assessment on Wednesday, November 3," the WHO said.

Last week, the WHO had said it is expecting one "additional piece" of information from Bharat Biotech regarding Covaxin. The WHO said there needs to be a thorough evaluation to ensure vaccines are safe and "cannot cut corners" before it is recommended for emergency use.

"We are aware that many people are waiting for WHO's recommendation for Covaxin to be included in the #Covid-19 Emergency Use Listing, but we cannot cut corners - before recommending a product for emergency use, we must evaluate it thoroughly to make sure it is safe and effective," the WHO said in a tweet on October 18.

Hyderabad-based Bharat Biotech, which has developed Covaxin, submitted EOI (Expression of Interest) to the WHO on April 19 for the vaccine's Emergency Use Listing (EUL).

India's first indigenous Covid-19 vaccine, Covaxin, demonstrated 77.8 per cent efficacy in its Phase 3 clinical trial.

In June, Bharat Biotech said it concluded the final analysis of Covaxin efficacy from Phase 3 trials. The Covaxin jab has been approved in 14 countries and 70 million doses have been distributed overseas, Bharat Biotech told WHO.

Bharat Biotech's Covaxin and AstraZeneca and Oxford University's Covishield are the two widely used vaccines in India.

The WHO has so far approved Covid-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna, and Sinopharm for emergency use.

https://www.indiatoday.in/coronavirus-outbreak/story/who-emergency-approval-covaxin-bharat-biotech-final-assessment-1869786-2021-10-27

Review of India's Covaxin Shot Underway: WHO

 A World Health Organization technical advisory group was reviewing data on India's Covaxin shot against COVID-19 on Tuesday with a decision on its emergency use listing likely soon, a spokesperson said.

"If all is in place and all goes well and if the committee is satisfied, we would expect a recommendation within the next 24 hours or so," Margaret Harris told journalists at a U.N. press briefing.

Millions of Indians have taken the shot produced by Bharat Biotech but many have been unable to travel pending the WHO approval.

https://www.usnews.com/news/world/articles/2021-10-26/review-of-indias-covaxin-shot-underway-who-says

Raytheon will lose 'several thousand' workers due to COVID-19 vaccine mandate - CEO

 Raytheon Technologies' top boss warned on Tuesday the U.S. aerospace and defense firm will lose 'several thousand' employees who refused to take COVID-19 vaccines, as it prepares to meet the Biden administrations Jan. 1 deadline for immunization.

"We will lose several thousand people," Raytheon Chief Executive Greg Hayes said in a CNBC interview on Tuesday, adding that staff hiring was underway. The company has a total of 125,000 U.S. employees.

Raytheon, the maker of Tomahawk missiles, last month said it will require all U.S. employees to be fully vaccinated by mid-December, after the Biden administration mandated immunization for nearly all federal employees and contractors, in a bid to increase vaccination coverage in the country.

Many companies, such as Boeing Co which hold U.S. government contracts, have announced vaccination mandates since then.

Separately, Hayes also said he expects Biden's vaccine mandate to cause "some disruption" in the supply chain in a post-earnings conference call with analysts.

https://finance.yahoo.com/news/raytheon-lose-several-thousand-workers-141022081.html

Federal employees group sues Biden over vaccine mandate

 More than 50 federal employees from across the U.S. government have banded together to sue the Biden administration over coronavirus vaccine mandates, according to court documents.

The Washington-based Federal Practice Group filed the complaint against President Joe Biden and top agency officials in the U.S. District Court for the District of Columbia on Oct. 19 on behalf of the dozens of federal workers and submitted an amended version on Oct. 20.

The Department of Homeland Security has 20 employees listed in the lawsuit, more than any other federal department or independent agency. All federal workers face a Nov. 22 deadline to be fully vaccinated, which is considered complete two weeks after the second dose of the Pfizer-BioNTech or Moderna vaccines, or one dose of the Johnson & Johnson shot.

“In rushing to force COVID-19 vaccinations on the federal workforce, the President’s edicts violate longstanding statutory prohibitions against inoculations with unlicensed vaccines, as well as the individual rights of government employees and contractors under the Rehabilitation Act and the Americans with Disabilities Act,” the complaint states. “Accordingly, plaintiffs who are representative of nearly every Federal Agency respectfully request relief from this Court in the form of injunctive relief stopping this illegal and unnecessarily broad and wide-ranging program.”

Feds for Medical Freedom, a coalition organizing federal workers and behind the lawsuit, asked the court to block Biden's policy from taking effect next month.

"On the basis that the mandates, as written and being implemented, are unlawful, federal employees are asking the judicial system to issue an order that prevents the mass firings of dedicated public servants," Feds for Medical Freedom wrote on its website.

The lawsuit states that the Biden administration violated federal workers' rights on three levels.

First, it says that Biden’s early September executive orders that employees receive full doses of the vaccine or face termination does not allow for a case-by-case review and employer accommodations and requires the government itself unlawfully inquire about each person’s medical history.

Second, the complaint states that firing employees on a perceived disability is illegal.

"Communicable diseases are considered disabilities. Through the issuance of these mandates, it is presumed that an unvaccinated individual at some point will contract COVID-19, a communicable disease," the complaint states.

It also cites the natural immunity that unvaccinated federal employees may have gotten through infection.

"The internet is replete with multiple studies confirming the lasting immunity to COVID-19 experienced by individuals who have previously contracted COVID-19. One notable one is from the Cleveland Clinic, which found that individuals previously infected with COVID-19 did not suffer reinfection, and that ultimately, Individuals who have had SARS-CoV-2 infection are unlikely to benefit from COVID-19 vaccination," the complaint states.

Third, it says Biden’s action goes against the informed consent principles of the Food, Drug, and Cosmetic Act, which states that all U.S. citizens have the right to accept or refuse medicines authorized under “emergency use” without having to worry about losing their job.

https://news.yahoo.com/coalition-federal-employees-sues-biden-232800342.html

Medpace rises after forecasting guidance ahead of expectations

 

• Medpace Holdings (NASDAQ:MEDP) is trading higher after posting a solid beat in its Q3 2021 financials. The company also projects its 2022 revenue to exceed the current Street forecasts.
• The topline has expanded ~28% YoY to $295.6M, indicating a backlog conversion rate of 17.0%, while net new business awards jumped ~29% YoY to $408.0M. Backlog as of September 30 stood at $1.8B, implying ~29% YoY growth from the prior-year period.
• Despite a 34% YoY rise in total direct costs, the GAAP net income grew ~17% YoY to $48.6M as EBITDA for the quarter increased ~16% YoY to $60.1M.
• The cash and equivalents at the end of the quarter stood at $398.4M indicating a ~43% rise from 2020 year-end.
• The company has raised the full year 2021 guidance to ~$1.14B – $1.15B from ~$1.11B – $1.15B projected three months ago.
• Medpace (MEDP) also expects its 2022 revenue and EBITDA to reach ~$1.40B – $1.46B and $262M – $278M, respectively. The consensus estimates for the company indicate $1.38B in revenue for 2022.

https://newsfilter.io/a/112e076e12656bf0d33687f0dad8811e

Sanders draws red lines on Medicare expansion, drug pricing plan in spending bill

 Senate Budget Committee Chairman Bernie Sanders (I-Vt.) said on Tuesday that a deal on President Biden’s spending bill must expand Medicare and include a plan to lower the cost of prescription drugs.

“Bottom line is that any reconciliation bill must include serious negotiations on the part of Medicare with the pharmaceutical industry, lower the cost of prescription drugs. That's what the American people want,” Sanders said. 

He added that a “serious reconciliation bill must include expanding Medicare to cover dental, hearing aids and eyeglasses.”

Sanders’s decision to draw red lines, while speaking with reporters on Capitol Hill, underscores the headache facing Democratic leadership as they try to reach a deal that can unify their various factions.  

Sanders warned in a tweet over the weekend that the Medicare expansion provision couldn’t be dropped. But Sen. Joe Manchin (D-W.Va.), speaking to reporters on Monday, reiterated he doesn’t support expanding Medicare amid concerns about the program's solvency. 

“My big concern right now is the 2026 deadline [for] Medicare insolvency and if no one’s concerned about that, I’ve got people — that’s a lifeline. Medicare and Social Security is a lifeline for people back in West Virginia, most people around the country,” Manchin warned.

“You’ve got to stabilize that first before you look at basically expansion. So if we’re not being fiscally responsible, that’s a concern,” he added.

Sanders declined to comment on Monday about Manchin’s comments. 

President Biden has warned that getting a deal that includes expanding Medicare to cover hearing, vision and dental would be a “reach.”

In addition to potentially dropping Sanders’ plan to expand the benefits covered by Medicare, negotiators are discussing limiting Medicare’s power to negotiate lower prices for only a handful of drugs, instead of the broad spectrum of medications that Sanders wanted covered.

The broader plan is opposed by a group of moderates including Sen. Kyrsten Sinema (D-Ariz.). 

https://thehill.com/policy/healthcare/578468-sanders-serious-spending-bill-must-include-medicare-expansion-drug-pricing

BioNTech to start building mRNA vaccine manufacturing plant in Africa in mid-2022

 BioNTech will construct a facility to make its mRNA vaccines in Africa in mid-2022 to scale up production of its COVID-19 jab for a continent that has been largely left behind in the global rollout of vaccines. Planning for the facility has been finalized and “initial assets” have been ordered, the German biotech said Tuesday.

That timing sets the Pfizer partner up to potentially beat out Moderna in building the first mRNA vaccine manufacturing site on the continent.

Moderna said it plans to pump $500 million into such a facility in Africa, but timing and location were kept under wraps earlier this month. "Mid-2022" is quite vague but at least puts pressure on the company to stick to a publicly disclosed time frame.

A caveat for BioNTech, though: it didn't reveal the precise location nor size of investment in its announcement. A hint might be in its partners on the plan: the Rwandan government and the Institut Pasteur de Dakar in Senegal. 

Most of Africa’s 50-plus countries have not inoculated more than 10% of their populations, because the continent does not have end-to-end mRNA vaccine manufacturing capabilities. The World Health Organization (WHO) and international bodies have called for increased resources on the continent, and some groups have requested Moderna and Pfizer license their mRNA technology to democratize the vaccine rollout. Pfizer is predicted to reel in $54.5 billion next year for its BioNTech-partnered jab, according to a report last week.

Construction of the plant will be important in the ongoing effort to get the world vaccinated against SARS-CoV-2, which continues to devastate many parts of the world, especially the Global South.

Once fully operational, the plant is expected to produce 50 million vaccine doses per year. That figure will rise to the “several hundreds of millions” after further manufacturing lines and sites are added to the continent, BioNTech said. To help contextualize those figures, the continent is home to more than 1.3 billion people.

The initial production estimate is a "pittance," the People's Vaccine Alliance said in response to the news. 

“Offering to only start building a facility in Africa in the middle of next year that will then at some point produce just 50 million doses – enough for just 2 percent of the continent’s population – is pittance when just one of their factories in Germany produces more than that each month," said Anna Marriott, policy lead for the group, in a statement.

The German biotech will initially staff, own and operate the plant. The company will eventually transfer the manufacturing capabilities to local partners. BioNTech is working with the Rwanda Development Board and Institut Pasteur de Dakar in Senegal to build up human resources and systems so “partners can take over ownership and operational duties,” the company said in a statement. Rwanda's government and the institute will boost the continent's fill and finish capacities to fulfill the local end-to-end process, BioNTech said.

The plan is the result of a meeting among BioNTech executives, Rwanda Minister of Health Dr. Daniel Ngamije, Senegal Minister of Foreign Affairs Aïssata Tall Sall, Director-General of Rwanda Biomedical Centre Dr. Sabin Nsanzimana and Directeur-General of Institut Pasteur de Dakar Dr. Amadou Alpha Sall earlier this fall. The nonprofit kENUP Foundation initiated the meeting.

BioNTech is also working on a malaria vaccine through a project with the foundation.

WHO’s regional director for Africa, Dr. Matshidiso Moeti, called the future facility a “life-saver” and “game-changer” for the continent.

“This is also crucial for transferring knowledge and know-how, bringing in new jobs and skills and ultimately strengthening Africa’s health security. WHO is ready to work with countries to step up their commitment to vaccine manufacturing,” Moeti said in a statement. Moeti was among WHO leaders in August who called for distribution of vaccines to the unvaccinated before wealthy countries dole out booster doses, saying "as some richer countries hoard vaccines, they make a mockery of vaccine equity.”

The FDA gave the green light for a booster dose of BioNTech's vaccine for certain populations in the U.S. last week, and the Centers for Disease Control and Prevention subsequently said people can mix and match their additional shot.

BioNTech and Pfizer are also in discussions about expanding their partnership with Biovac, a Cape Town-based vaccine manufacturer, the German company said Tuesday. The parties came together in July under a collaboration in which drug substance from Europe will be delivered to Biovac’s South Africa facility to handle fill-finish duties and eventually distribute 100 million doses of the vaccine to the African Union annually.

https://www.fiercepharma.com/manufacturing/biontech-to-build-mrna-vaccine-manufacturing-plant-africa-mid-2022-plans-finalized