Categories
Science

Catalent announces launch of private offering of $475 million of senior unsecured notes due 2029

SOMERSET, N.J. — (BUSINESS WIRE) — Catalent, Inc. (“Catalent”) (NYSE: CTLT), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that its wholly owned subsidiary, Catalent Pharma Solutions, Inc. (the “Operating Subsidiary”), intends to offer, subject to market and other conditions, $475 million in aggregate principal amount of senior unsecured notes due 2029 (the “Notes”) in a private offering (the “Private Offering”) that is exempt from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”).

The Operating Subsidiary intends to use the net proceeds from the Private Offering to (i) redeem in full its 4.875% senior notes due 2026 (the “2026 Notes”), plus any accrued and unpaid interest thereon, (ii) pay related fees and expenses, and (iii) provide cash on its balance sheet for general corporate purposes, including capital expenditures.

The Notes will be guaranteed by all of the wholly owned U.S. subsidiaries of the Operating Subsidiary that guarantee its senior secured credit facilities. The Notes will not be guaranteed by PTS Intermediate Holdings, LLC or Catalent, the direct and indirect parent companies of the Operating Subsidiary.

The Notes will be offered and sold to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act and to certain non-U.S. persons outside the United States pursuant to Regulation S under the Securities Act.

The Notes have not been and will not be registered under the Securities Act or applicable state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any of the Notes or any other securities described above and shall not constitute an offer, solicitation or sale in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful. This press release does not constitute a notice of redemption under the Indenture, or an offer to tender for, or purchase, any of the 2026 Notes or any other security.

There can be no assurance that the Operating Subsidiary will (i) consummate the Private Offering on favorable terms or at all or (ii) redeem the 2026 Notes.

About Catalent

Catalent, Inc. (NYSE: CTLT), an S&P 500® Company, is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 14,000 people, including over 2,400 scientists and technicians, at more than 40 facilities across four continents, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com.

Forward-Looking Statement Notice

This release contains both historical and forward-looking statements, including statements regarding the Private Offering and plans, projections and estimates regarding the use of proceeds from the Private Offering. All statements other than statements of historical fact, are, or may be deemed to be, forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally can be identified because they relate to the topics set forth above or by the use of statements that include phrases such as “believe,” “expect,” “anticipate,” “intend,” “estimate,” “plan,” “project,” “foresee,” “likely,” “may,” “will,” “would,” or other words or phrases with similar meanings. Similarly, statements that describe Catalent’s objectives, plans, or goals are, or may be, forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Catalent’s expectations and projections. Some of the factors that could cause actual results to differ include, but are not limited to, the following: the current or future effects of the COVID-19 pandemic on Catalent’s and its clients’ businesses; participation in a highly competitive market and increased competition that may adversely affect Catalent’s business; demand for Catalent’s offerings, which depends in part on Catalent’s customers’ research and development and the clinical and market success of their products; product and other liability risks that could adversely affect Catalent’s results of operations, financial condition, liquidity and cash flows; failure to comply with existing and future regulatory requirements; failure to provide quality offerings to customers could have an adverse effect on Catalent’s business and subject it to regulatory actions and costly litigation; problems providing the highly exacting and complex services or support required; global economic, political and regulatory risks to the operations of Catalent; inability to enhance existing or introduce new technology or service offerings in a timely manner; inadequate patents, copyrights, trademarks and other forms of intellectual property protections; fluctuations in the costs, availability, and suitability of the components of the products Catalent manufactures, including active pharmaceutical ingredients, excipients, purchased components and raw materials; changes in market access or healthcare reimbursement in the United States or internationally; fluctuations in the exchange rate of the U.S. dollar against other currencies, including as a result of the U.K.’s exit from the European Union; adverse tax, legislative or regulatory initiatives or challenges or adjustments to Catalent’s tax positions; loss of key personnel; risks generally associated with information systems; inability to complete any future acquisitions or other transactions that may complement or expand Catalent’s business or divest of non-strategic businesses or assets and difficulties in successfully integrating acquired businesses and realizing anticipated benefits of such acquisitions; risks associated with timely and successfully completing, and correctly anticipating the future demand predicted for, capital expansion projects at existing or any acquired facilities, offerings and customers’ products that may infringe on the intellectual property rights of third parties; environmental, health and safety laws and regulations, which could increase costs and restrict operations; labor and employment laws and regulations or labor difficulties, which could increase costs or result in operational disruptions; additional cash contributions required to fund Catalent’s existing pension plans; substantial leverage resulting in the limited ability of Catalent to raise additional capital to fund operations and react to changes in the economy or in the industry; and exposure to interest-rate risk to the extent of Catalent’s variable-rate debt preventing Catalent from meeting its obligations under its indebtedness. For a more detailed discussion of these and other factors, see the information under the caption “Risk Factors” in Catalent’s Annual Report on Form 10-K for the fiscal year ended June 30, 2020, filed August 31, 2020. All forward-looking statements speak only as of the date of this release or as of the date they are made, and Catalent does not undertake to update any forward-looking statement as a result of new information or future events or developments except to the extent required by law.

Contacts

Catalent, Inc.

Investor Contact:

Paul Surdez, 732-537-6325

investors@catalent.com

Categories
Environment Science Technology

The Webb Telescope, NASA’s Golden Surfer, is almost ready, again

After decades of fits and starts, the multibillion dollar successor to the Hubble telescope is expected to launch as soon as this fall.

 

— NYT: Top Stories

Categories
Science

Legend Biotech announces BCMA CAR-T Therapy Cilta-cel accepted for accelerated assessment in Europe for the treatment of relapsed and/or refractory multiple myeloma

SOMERSET, N.J. — (BUSINESS WIRE) — Legend Biotech Corporation (NASDAQ: LEGN) (“Legend Biotech”), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has accepted a request for an accelerated assessment of the Marketing Authorisation Application (MAA) for the investigational B-cell maturation antigen (BCMA) targeted chimeric antigen receptor T-cell (CAR-T) therapy ciltacabtagene autoleucel (cilta-cel).

The request was made by Legend’s collaborator, Janssen Biotech, Inc. (Janssen). An accelerated assessment of the MAA is granted by the CHMP when a medicinal product is expected to be of major public health interest and therapeutic innovation.1

The MAA, which is targeted for submission in the first half of 2021, is based on results from the pivotal Phase 1b/2 CARTITUDE-1 study which evaluated the efficacy and safety of cilta-cel in the treatment of patients with relapsed and/or refractory multiple myeloma. Results from the study were presented (Abstract #177) at the 62nd American Society of Hematology Annual Meeting last month.2

“The acceptance of the request for an accelerated assessment is an important testament for the potential use of cilta-cel in treating patients with multiple myeloma,” said Ying Huang, PhD, CEO and CFO of Legend Biotech. “Together with our collaborator Janssen, we look forward to working with the EMA as we advance this treatment option toward market and provide new hope for patients.”

The accelerated assessment milestone in Europe follows the December 2020 announcement of initiation of a rolling submission of the Biologics License Application for cilta-cel to the U.S. Food and Drug Administration (FDA). Cilta-cel previously received a PRIority MEdicines (PRiME) designation from the European Commission in April 2019.

About CARTITUDE-1

CARTITUDE-1 (NCT03548207) is an ongoing Phase 1b/2, open-label, multicenter study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory multiple myeloma, 99 percent of whom were refractory to the last line of treatment; 88 percent of whom were triple-class refractory (to at least 1 immunomodulatory drug [IMiD], 1 proteasome inhibitor [PI] and 1 anti-CD38 antibody).3

The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). The Phase 2 portion further evaluated the efficacy of cilta-cel with overall response rate as the primary endpoint. 3

About Ciltacabtagene autoleucel (cilta-cel)

Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 outside of China and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed and/or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel.

In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.4 Although treatment may result in remission, unfortunately, patients will most likely relapse. 5 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.6 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy.7,8 While some patients with multiple myeloma have no symptoms until later stages of the disease, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.9 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options.10

About Legend Biotech

Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of over 800 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover, develop, and manufacture cutting edge cell therapies for patients in need.

We are engaged in a strategic collaboration to develop and commercialize our lead product candidate, ciltacabtagene autoleucel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. This candidate is currently being studied in registrational clinical trials.

To learn more about Legend Biotech, visit us on LinkedIn, or on Twitter @LegendBiotech or at www.legendbiotech.com.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s clinical efforts, its partnership with Janssen, and the regulatory submissions and reviews relating to cilta-cel, including the EMA’s accelerated assessment of the MAA for cilta-cel. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the factors discussed in the “Risk Factors” section of the prospectus filed with the Securities and Exchange Commission on June 8, 2020. Any forward-looking statements contained in this press release speak only as of the date hereof, and Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

1 EMA. Accelerated Assessment. Available at: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/accelerated-assessment. Accessed January 2021.

2Madduri, D et al. CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel, a B-Cell Maturation Antigen–Directed Chimeric Antigen Receptor T Cell Therapy, in Relapsed/Refractory Multiple Myeloma. Abstract #177. Oral Presentation. Presented at 2020 American Society of Hematology Annual Meeting

3CARTITUDE-1 (NCT03548207). Available: https://clinicaltrials.gov/ct2/show/NCT03548207. Accessed January 2021.

4 American Society of Clinical Oncology. Multiple myeloma: introduction. Available at: https://www.cancer.net/cancer-types/multiple-myeloma/introduction. Accessed January 2021.

5 Abdi J, Chen G, Chang H, et al. Drug resistance in multiple myeloma: latest findings and new concepts on molecular mechanisms. Oncotarget. 2013;4:2186–2207.

6 National Cancer Institute. NCI dictionary of cancer terms: relapsed. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=45866. Accessed January 2021.

7 National Cancer Institute. NCI dictionary of cancer terms: refractory. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=350245. Accessed January 2021.

8 Richardson P, Mitsiades C, Schlossman R, et al. The treatment of relapsed and refractory multiple myeloma. Hematology Am Soc Hematol Educ Program. 2007:317-23.

9 American Cancer Society. Multiple myeloma: early detection, diagnosis and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Accessed January 2021

10 Kumar SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012;26:149-57.

Contacts

For Media and Investor Relations inquiries:
Jessie Yeung, Head of Corporate Finance and Investor Relations, Legend Biotech

jessie.yeung@legendbiotech.com or investor@legendbiotech.com

Surabhi Verma, Manager of Investor Relations and Corporate Communications, Legend Biotech USA Inc.

Surabhi.Verma@legendbiotech.com or media@legendbiotech.com

For Medical Affairs inquiries:
Tonia Nesheiwat, Executive Director, Medical Affairs, Legend Biotech

tonia.nesheiwat@legendbiotech.com or medicalinformation@legendbiotech.com

Categories
Science

The Latest: France’s Sanofi to help make rival vaccine

FILE – In this photo Nov.30, 2020 file photo the logo of French drug maker Sanofi is picture at the company’s headquarters, in Paris. French drug maker Sanofi said Wednesday it will help manufacture 125 million doses of the coronavirus vaccine developed by rivals Pfizer and BioNTech, while its own vaccine candidate faces delays. (AP Photo/Thibault Camus, File)

PARIS — French drug maker Sanofi says it will help manufacture 125 million doses of the coronavirus vaccine developed by rivals Pfizer and BioNTech, while its own vaccine candidate faces delays.

Germany-based BioNTech will initially produce the vaccines at Sanofi facilities in Frankfurt, starting in the summer, according to a Sanofi statement Wednesday. The company did not reveal financial details of the agreement.

The French government has been pressing Sanofi to use its facilities to help make rival vaccines, given high demand and problems with supplies of the few vaccines that are already available.

Sanofi and British partner GlaxoSmithKline will start a new phase-2 trial of their COVID-19 vaccine next month, Sanofi said. The two companies said last month that their vaccine won’t be ready until late 2021 because the shot’s effectiveness in older people needed to be improved.

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THE VIRUS OUTBREAK:

— U.S. boosting vaccine deliveries amid complaints of shortages

— U.K. becomes first country in Europe to pass 100,000 coronavirus deaths

— U.S president says he’s ‘bringing back the pros’ for virus briefings

— IOC, Tokyo Olympics to unveil rule book for beating pandemic

— Follow all of AP’s pandemic coverage at https://apnews.com/hub/coronavirus-pandemic, https://apnews.com/hub/coronavirus-vaccine and https://apnews.com/UnderstandingtheOutbreak

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HERE’S WHAT ELSE IS HAPPENING:

BEIJING — China has given more than 22 million coronavirus vaccine shots to date as it carries out a drive ahead of next month’s Lunar New Year holiday, health authorities said Wednesday.

The effort, which began six weeks ago, targets key groups such as medical and transport workers and has accelerated vaccinations in China. About 1.6 million doses had been given over several months before the campaign began.

“The carrying out of vaccination has been ongoing in a steady and orderly manner,” Zeng Yixin, vice chairman of the National Health Commission Said at a news conference.

He said that 22.76 million doses had been administered as of Tuesday. It’s not clear how many people that represents since the vaccine is given in two doses, and some may have received their second shot.

China, which largely stopped the spread of the virus last spring, has seen fresh outbreaks this winter in four northern provinces. About 1,800 new cases have been reported since mid-December, including two deaths.

Authorities are strongly discouraging people from traveling during the Lunar New Year holiday, a time when Chinese traditionally return to their hometowns for family gatherings.

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NEW DELHI — India has vaccinated 2 million health workers in less than two weeks and recorded 12,689 new coronavirus positive cases in the past 24 hours, a sharp decline from a peak level of nearly 100,000 in mid-September.

The health Ministry said the daily new cases had fallen below 10,000 on Tuesday with 9,102 cases. The daily new positive cases were 9,304 on June 4 last year.

India’s fatalities dropped to 137 in the past 24 hours from a peak level of 1,089 daily deaths in September. India’s total positive cases since the start of the epidemic have reached 10.6 million, the second highest after the United States with 25.43 million cases.

India started inoculating health workers on Jan. 16 in what is likely the world’s largest COVID-19 vaccination campaign.

India is home to the world’s largest vaccine makers. Authorities hope to give shots to 300 million people. The recipients include 30 million doctors, nurses and other front-line workers.

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SEOUL, South Korea — South Korea has reported new 559 cases of the coronavirus, its highest daily increase in 10 days, as health workers scrambled to slow transmissions at religious facilities, which have been a major source of infections throughout the pandemic.

The figures released by the Korea Disease Control and Prevention Agency on Wednesday brought the national caseload to 76,429, including 1,378 deaths.

The agency said 112 of the new cases came from the southwestern city of Gwangju where more than 100 infections have so far been linked to a missionary training school. An affiliated facility in the central city of Daejeon has been linked to more 170 infections.

Nearly 300 of the new cases came from the Seoul metropolitan area, home to half of the country’s 51 million people, where infections have been tied to various places, including churches, restaurants, schools and offices.

—-

JUNEAU, Alaska — Alaska has detected the state’s first known case of the coronavirus variant identified last year in the United Kingdom, officials said Tuesday.

The infected person is an Anchorage resident who had traveled to a state where the variant had already been detected, the Alaska health department said. The person first experienced symptoms on Dec. 17, was tested three days later and received a positive result on Dec. 22.

The resident lived with another person in Anchorage, who also became ill. Both isolated and have since recovered, officials said.

It was not yet clear if the second person also was infected with the variant.

Dr. Joe McLaughlin, the state epidemiologist, said in a news release that the discovery of the variant is not surprising because viruses “constantly change through mutation.”

He said this is one of several “variants that has been carefully tracked because it appears to spread more easily and quickly than other strains of the virus.”

Dr. Anne Zink, Alaska’s chief medical officer, said it is likely the variant will be detected again soon.

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BOSTON — In his annual State of the Commonwealth address, Republican Gov. Charlie Baker defended his vaccine distribution plan, which some have criticized for being confusing and too narrowly focused at first.

Baker said the state is prepared to distribute and administer all the vaccine shots delivered by the federal government and is rapidly expanding the number of vaccination sites.

“Vaccinating 4 million adults in Massachusetts as the doses are allocated by the federal government is not going to be easy. But be assured that we will make every effort to get this done as quickly and efficiently as possible,” he said. “We can only move as fast as the federal government delivers the vaccines.”

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SEATTLE – Washington Gov. Jay Inslee on Tuesday touted big improvements in distributing the COVID-19 vaccines, but he also urged residents to remain vigilant as new, more contagious variants of the disease spread in the state.

Inslee said more than 36,000 doses were administered in Washington on Sunday and 39,000 on Monday — a big jump from about 16,000 a week earlier, and on the way toward the state’s goal of 45,000 per day.

The number of vaccines actually administered could be even higher, given lags in reporting, but as of Monday more than 500,000 doses had been administered statewide, with four mass vaccination sites due to open this week.

President Joe Biden announced Tuesday the federal government is boosting vaccine supplies to the states by 16% over the next three weeks, giving states more certainty about upcoming deliveries than the one-week notice the Trump administration had been providing.

— Associated Press

Categories
Science

Six stars, six eclipses: ‘The fact that it exists blows my mind’

A handful of other six-star systems have been discovered, but this one is unique.

 

— NYT: Top Stories

Categories
Science

Hospital workers start to ‘turn against each other’ to get vaccine

“I am so disappointed and saddened that this happened,” a New York hospital executive wrote to his staff after workers who did not have priority cut the line for the vaccine.

— NYT: Top Stories

Categories
Science

The new Covid variant in the UK: Questions and answers

A newly identified variant of the SARS-CoV-2 virus appears to be more contagious than established ones. But it is not any deadlier, nor does it evade the current vaccines.

— NYT: Top Stories

Categories
Science

What you can do post-vaccine, and when

Particularly in the early months of vaccination, many activities should wait, experts say — and plan to keep your masks.

— NYT: Top Stories

Categories
Science

Feds passed up chance to lock in more Pfizer vaccine doses

President Donald Trump speaks after awarding the Presidential Medal of Freedom, the highest civilian honor, to Olympic gold medalist and former University of Iowa wrestling coach Dan Gable in the Oval Office of the White House, Monday, Dec. 7, 2020, in Washington. (AP Photo/Patrick Semansky)

 

WASHINGTON (AP) — The Trump administration opted last summer not to lock in a chance to buy millions of additional doses of one of the leading coronavirus vaccine contenders, a decision that could delay the delivery of a second batch of doses until manufacturer Pfizer fulfills other international contracts.

The revelation, confirmed Monday by people familiar with the matter, came a day before President Donald Trump aimed to take credit for the speedy development of forthcoming coronavirus vaccines at a White House summit Tuesday.

Pfizer’s vaccine is expected to be endorsed by a panel of Food and Drug Administration advisers as soon as this week, with delivery of 100 million doses — enough for 50 million Americans — expected in coming months.

Under its contract with Pfizer, the Trump administration committed to buy an initial 100 million doses, with an option to purchase as many as five times more.

This summer, the White House opted not to lock in an additional 100 million doses for delivery in the second quarter of 2021, according to people who spoke about the matter on condition of anonymity because they were not authorized to discuss it publicly.

Days ahead of the vaccine’s expected approval, the administration is reversing course, but it is not clear that Pfizer, which has since made commitments to other countries, will be able to meet the latest request on the same timeline.

The Pfizer vaccine is one of two on track for emergency FDA authorization this month, the other coming from drugmaker Moderna.

The Trump administration insisted late Monday that between those two vaccines and others in the pipeline, the U.S. will be able to accommodate any American who wants to be vaccinated by the end of the second quarter of 2021.

The administration’s decision not to lock in additional Pfizer purchases last summer was first reported by The New York Times. Health and Human Services Secretary Alex Azar told NBC the administration is “continuing to work across manufacturers to expand the availability of releasable, of FDA-approved vaccine as quickly as possible. … We do still have that option for an additional 500 million doses.”

Seeking to tamp down public skepticism over the vaccine and secure a key component of Trump’s legacy, Tuesday’s summit will highlight the administration’s plans to distribute and administer the vaccine. But officials from President-elect Joe Biden’s transition team, which will oversee the bulk of the largest vaccination program in the nation’s history once he takes office Jan. 20, were not invited.

The “Operation Warp Speed” summit will feature Trump, Vice President Mike Pence and a host of government experts, state leaders and business executives, as the White House looks to explain that the vaccine is safe and lay out the administration’s plans to bring it to the American people.

Senior administration officials provided details on the summit on Monday. An official with the Biden transition confirmed no invitation was extended.

Officials from the pharmaceutical companies developing the vaccines also were not expected to attend, despite receiving invitations, according to people familiar with the matter. Some expressed concerns about the event contributing to the politicization of the vaccine development process and potentially further inhibiting public confidence in the drugs.

Trump is set to kick off the event with remarks aiming to “celebrate” vaccine development, according to an official who previewed the event. Trump also will sign an executive order to prioritize Americans for coronavirus vaccines procured by the federal government. A second official said the order would restrict the U.S. government from donating doses to other nations until there is excess supply to meet domestic demand. Both officials spoke on condition of anonymity to discuss plans for the summit.

It was not immediately clear what, if any, impact the order would have on other nations’ abilities to access the vaccines. Canadian Prime Minister Justin Trudeau announced Monday he expects his country to receive about 250,000 doses of a vaccine from Pfizer by the end of the year.

The Food and Drug Administration’s panel of outside vaccine experts is to meet Thursday to conduct a final review of the Pfizer drug, and it will meet later this month on a vaccine developed by Moderna. The FDA is not required to follow the panel’s advice, though it usually does. Agency decisions on the two drugs are expected within days of each meeting. Both have been determined to be 95% effective against the virus that causes COVID-19. Plans call for distributing and then administering about 40 million doses of the two companies’ vaccines by the end of the year — with the first doses shipping within hours of FDA clearance.

Biden said Friday that “there’s no detailed plan that we’ve seen” for how to get the vaccines out of containers, into syringes and then into people’s arms.

Trump administration officials insist that such plans have been developed, with the bulk of the work falling to states and municipal governments to ensure their most vulnerable populations are vaccinated first. The administration says it has leveraged partnerships with manufacturers, distributers and health care providers, so that outside of settings like veterans’ hospitals, “it is highly unlikely that a single federal employee will touch a dose of vaccine before it goes into your arm.”

In all, about 50,000 vaccination sites are enrolled in the government’s distribution system, the officials said.

Each of the forthcoming vaccines has unique logistical challenges related to distribution and administration. The Pfizer vaccine must be transported at super-cooled temperatures, and comes in batches of 975 doses. Each vial contains 5 doses, requiring careful plannning. The administration has prepared detailed videos for providers on how to safely prepare and administer doses, to be posted after the FDA issues its emergency use authorization.

One such plan is to be announced Tuesday: Pharmacy chains CVS and Walgreens have stood up a “mobile vaccination service” ready to vaccinate people in every nursing home and long-term care facility in the country. The roughly 3 million residents of those facilities are among the most vulnerable for COVID-19 and have been placed at the front of the line to access the vaccine, along with more than 20 million healthcare workers. So far 80-85% of the facilities have signed on to the service, the officials said.

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AP writers Jonathan Lemire in Wilmington, Delaware, and Linda Johnson in Trenton, New Jersey, contributed to this report.

— Associated Press

Categories
Science

Jupiter and Saturn are about to do something not seen for nearly 800 years

The two largest planets in the Solar System, Jupiter and Saturn have fascinated astronomers for hundreds of years. But the two gas giants will do something next month not seen since the Middle Ages — they will look like a double planet.

 

— FOX News