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Pfizer to close Durham and Morrisville, North Carolina facilities amid major restructuring effort

In a strategic initiative to streamline operations, Pfizer said it would close facilities in Durham and Morrisville, North Carolina. The company aims to cut at least $3.5 billion in costs.

The company now employs more than 80,000 people worldwide, with roughly 4,000 based in North Carolina.

The closures will not affect Pfizer’s two largest facilities in North Carolina — Sanford and Rocky Mount. The Rocky Mount facility, which specializes in producing injectable medicines for hospitals, employs approximately 3,200 people and has recently resumed operations after a tornado damaged it in July. The Durham Clinical Manufacturing Facility, on the other hand, opened in December 2021. The company initially planned for the facility to create 50 jobs and relocate 40 employees from Chapel Hill. The exact number of people employed at the facility at the time of the announcement remains unclear.

The company has lowered its full-year revenue guidance to $58.0 to $61.…

Pfizer and BioNTech secure FDA nod for omicron-adapted COVID-19 booster for kids under 5

COVID-19 vaccine developers Pfizer (NYSE:PFE) and its partner BioNTech (Nasdaq:BNTX) have won emergency use authorization (EUA) for a single booster dose of their omicron BA.4/BA.5-adapted bivalent COVID-19 booster for kids between 6 months and 4 years of age.

The booster can be administered at least two months after completing the primary vaccination series with three doses of the original Pfizer-BioNTech COVID-19 vaccine. Additionally, FDA has authorized the bivalent vaccine for use as the third dose in a primary series for the same age group. The agency, however, has not yet authorized a fourth booster dose.

Trial data Supports bivalent vaccine safety and efficacy

The EUA is based on data from substudies within the companies’ Phase 1/2/3 trial (NCT05543616) evaluating the safety, tolerability and immunogenicity of a fourth bivalent vaccine dose in 300 children aged 6 months to 4 years. A subset of 60 study participants within the same age group demonst…

FDA greenlights 786,000 additional monkeypox vaccine doses

[Photo by Artem Podrez from Pexels]

FDA has signed off on a supplement to the biologics license for Bavarian Nordic’s (OTCMKTS:BVNRY) Jynneos vaccine, which is indicated for both monkeypox and smallpox. The move will make an additional 786,000 doses of vaccine available for use in the U.S.

The extra doses are available following an FDA expedited inspection and approval of Bavarian Nordic’s fill-and-finish capabilities.

HHS is moving to ship the doses to states and jurisdictions as soon as it can, according to the U.S. Department of Health and Human Services Secretary Xavier Becerra.

Becerra indicated that the federal government would continue to ramp up the distribution of further monkeypox vaccine doses in the near future.

The U.S. has been working to procure 5.5 million monkeypox vaccine doses for 2023.

The country had distributed more than 300,000 vaccine doses in July.

“We …

Amazon partners with Fred Hutchinson Cancer on cancer vaccine trial

Amazon (Nasdaq:AMZN) and the Fred Hutchinson Cancer Research Center are working together on a Phase 1 FDA-approved clinical study that will investigate a personalized neo-antigen peptide vaccine for melanoma and certain types of breast cancer.

According to a listing on clinicaltrials.gov, the study aims to recruit 20 participants.

Amazon will offer scientific and machine learning capabilities in the alliance with the Seattle-based Fred Hutchinson Cancer Research Center.

In particular, the Phase 1 study will focus on patients with stage IIIC-IV melanoma or hormone-receptor-positive HER2 negative breast cancer. In addition, patients’ cancer in the trial must either be metastatic or refractory.

Patients in the study will receive a weekly intramuscular injection of poly ICLC in weeks when no vaccine is administered. Poly ICLC is an immunostimulant composed of polyinosinic-polycytidylic acid, carboxymethylcellulose and polylysine.

Two weeks afte…

HHS makes 144,000 more doses of Jynneos monkeypox vaccine available

The U.S. Department of Health and Human Services (HHS) has said it would make available an additional 144,000 doses of the Jynneos vaccine doses available to states and jurisdictions.

Bavarian Nordic A/S (OMX:BAVA) is the manufacturer of the vaccine.

Jynneos won FDA approval for both smallpox and monkeypox in 2019.

There have been approximately 700 confirmed monkeypox cases in the U.S., according to the CDC.

HHS said it would begin shipping the most recent doses from the Strategic National Stockpile (SNS) on July 11.

“We are using every tool we have to increase and accelerate Jynneos vaccine availability in jurisdictions that need them the most,” said Steve Adams, Director of the Strategic National Stockpile, in a statement. “In less than ten days, we’ve made available 200,000 Jynneos vaccine doses in communities where transmission has been the highest and with high-risk populations, and significantly scaled testing availability and conveni…

Pfizer invests $95 million in vaccine firm Valneva

After struggling to find support for its inactivated whole-virus COVID-19 vaccine candidate VLA2001, French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) has received a €90.5 ($95) million investment from Pfizer (NYSE:PFE), which amounts to 8.1% of the company’s share capital at a price of €9.49 per share.

The Saint-Herblain, France–based company plans on using the funding to support a planned Phase 3 study involving the Lyme disease vaccine candidate VLA15. Pfizer will lead the Phase 3 study, scheduling it for the third quarter of 2022.

In February, Valneva and Pfizer announced positive data from a Phase 2 study of the VLA15 vaccine. The data suggested that a three-dose primary series of the vaccine promised to offer a robust immune response.

In related news, the European Medicines Agency recently recommended authorizing Valneva’s VLA2001 COVID-19 vaccine for individuals between 18 and 50.

After the vaccine won regulatory approval …

U.S. secures option to purchase millions of monkeypox vaccine doses from Bavarian Nordic

As monkeypox cases are investigated in North America and Europe, Bavarian Nordic A/S (OMX:BAVA) has secured a contract worth potentially $119 million with Biomedical Advanced Research and Development Authority (BARDA) to convert bulk vaccine into freeze-dried doses of Jynneos vaccine.

Jynneos was FDA approved for both smallpox and monkeypox in 2019.

Smallpox and monkeypox are broadly similar with the latter causing lymph nodes swelling while the former does not. Smallpox and monkeypox are broadly similar with the latter causing lymph nodes swelling while the former does not. Monkeypox also tends to be milder.

BARDA has additional options to convert up to roughly 13 million freeze-dried doses of the Jynneos vaccine that would likely be manufactured in 2024 and 2025.

BAVA shares have surged in recent days. Today, it rose 18.4% to 216.60 DKK. In the past five days, the stock has increased 63.6%.

Monkeypox remains extremely rare in the U.S., CD…

Moderna’s first bivalent COVID-19 vaccine booster candidate shows promise

Moderna’s (NYSE:MRNA) bivalent booster COVID-19 vaccine candidate, mRNA-1273.211, bested its first-generation mRNA-1273 vaccine in a Phase 2/3 study.

The study compared the neutralizing antibody levels generated from both vaccine boosters. The mRNA-1273.211 vaccine booster candidate offered superior performance against all variants of concern, including omicron.

Get the full story from our sister site, Drug Discovery & Development.

GSK halts Phase 3 RSV maternal vaccine candidate program

GlaxoSmithKline plc (LSE/NYSE:GSK) has announced that it has chosen to stop enrollment and vaccination of studies testing its respiratory syncytial virus (RSV) maternal vaccine candidate in women.

The company had announced a voluntary pause of the trials NCT04605159, NCT04980391 and NCT05229068 on February 18.

GSK did not elaborate on the reason for halting the trials.

GSK’s AReSVi 006 Phase 3 trial (NCT04886596) for RSV older adults 60 years and older is ongoing.

GSK shares were down 2.25% to $41.72 in mid-day trading.

Vaccine makers have attempted in vain to create a vaccine for RSV, which CDC links to 14,000 deaths in adults aged 65 years or older annually.

Several companies have RSV vaccine candidates, including Moderna (NASDAQ:MRNA) and Janssen (NYSE:JNJ).

Moderna and Pfizer look forward to fourth dose of COVID-19 vaccine

Photo by Artem Podrez from Pexels

As COVID-19 case counts surge worldwide, executives at Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) have voiced support for additional doses of their COVID-19 vaccines.

Moderna CEO Stéphane Bancel predicted that a fourth dose would be necessary by the fall as the protection of vaccine-induced antibodies fades.

In late December, Pfizer’s chief scientific officer Dr. Mikael Dolsten said a fourth dose could be necessary in the U.S. by spring.

Pfizer executives predicted that the COVID-19 wouldn’t become endemic across the world until 2024, according to Reuters. But, that said, the emergence of variants and global vaccination could influence the trajectory of the pandemic.

Several countries are considering moving forward with providing fourth doses of COVID-19 vaccine. Israel, Canada and Chile have already begun doling out fourth doses to some individuals. In t…

Pfizer and BioNTech win EUA for booster for individuals 16 and older

Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) have received emergency use authorization for BNT162b2 mRNA COVID-19 vaccine for individuals at least 16 years old.

To coincide with the announcement, CDC Director Dr. Rochelle Walensky recommended that everyone 16 and older receive a booster. “Although we don’t have all the answers on the Omicron variant, initial data suggests that COVID-19 boosters help broaden and strengthen the protection against Omicron and other variants,” Walensky said. Recipients need to wait at least six months after completing the primary vaccination series.

The Pfizer-BioNTech is now the only COVID-19 vaccine to win authorization for adolescents between 16 and 17.

“Today’s decision by the FDA to further expand the Emergency Use Authorization of a booster dose of our COVID-19 vaccine is a critical milestone as we continue to stay vigilant in addressing the virus,” said Albert Bourla, Pfizer CEO, in a press release.<…

FDA hits pause on reviewing Moderna COVID-19 vaccine for adolescents

The FDA has decided to postpone deciding whether to extend emergency use authorization of Moderna’s (NSDQ:MRNA) COVID-19 vaccine.

Some regulators have concluded that the risk of myocarditis is higher in recipients of the Moderna vaccine than the Pfizer-BioNTech vaccine.

Japan recently authorized men 30 and under who received an initial dose of the Moderna vaccine to receive a second dose of the Pfizer-BioNTech vaccine. Japanese authorities also recommended requiring a four-week interval between the first and second doses in this subpopulation — the same as the 28-day interval Moderna recommended for the second dose.

Get the full story from our sister site, Drug Discovery & Development.