RNA vaccines

OCUGEN ALERT: Bragar Eagel & Squire, P.C. is Investigating Ocugen, Inc. on Behalf of Ocugen Stockholders and Encourages Investors to Contact the Firm

Saturday, June 12, 2021 - 3:00am

Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Ocugen, Inc. (NASDAQ: OCGN) on behalf of Ocugen stockholders.

Key Points: 
  • Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Ocugen, Inc. (NASDAQ: OCGN) on behalf of Ocugen stockholders.
  • Our investigation concerns whether Ocugen has violated the federal securities laws and/or engaged in other unlawful business practices.
  • On May 26, 2021, Ocugen announced that it planned to submit to the FDA an Emergency Use Authorization (EUA) application for COVAXIN, a COVID-19 vaccine, in June 2021.
  • Shares of Ocugen fell by more than 24% in intraday trading on the same day, based on this news.

COVID-19 Vaccine Drug Substance Manufactured by Emergent BioSolutions Authorized as Part of Johnson & Johnson’s Emergency Use Authorization

Friday, June 11, 2021 - 9:35pm

We are pleased that these initial doses of the Johnson & Johnson COVID-19 vaccine will be available to protect millions of people from this deadly disease, said Robert G. Kramer, president and chief executive officer of Emergent.

Key Points: 
  • We are pleased that these initial doses of the Johnson & Johnson COVID-19 vaccine will be available to protect millions of people from this deadly disease, said Robert G. Kramer, president and chief executive officer of Emergent.
  • We look forward to working with the FDA and Johnson & Johnson toward the release of additional batches and resuming production at our Bayview facility.
  • Emergent is actively addressing issues identified by the FDA at its Bayview facility and plans to resume manufacturing of the Johnson & Johnson COVID-19 vaccine drug substance after Emergent, Johnson & Johnson, and FDA are confident that the steps taken have remedied shortcomings.
  • Since mid-2020, Emergent has harnessed its capabilities to rapidly build and scale up capacity to manufacture bulk drug substance for Johnson & Johnsons COVID-19 vaccine.

New study to monitor COVID-19 illness and vaccine safety, effectiveness in children and youth in Canada

Friday, June 11, 2021 - 3:34pm

Continued surveillance for any vaccine is an important component of ensuring the safety and effectiveness of all vaccines for the general population.

Key Points: 
  • Continued surveillance for any vaccine is an important component of ensuring the safety and effectiveness of all vaccines for the general population.
  • This research study is complemented by ongoing safety monitoring by the Public Health Agency of Canada, Health Canada, and multiple public health organizations.
  • This study, which began on June 1, will build upon the information gathered in our research teams Canadian Paediatric Surveillance Program COVID-19 Study ( CPSP COVID-19 Study ).
  • The Vaccine Surveillance Reference Group (VSRG) supports the monitoring of the safety and effectiveness of COVID-19 vaccines in Canada.

Moderna and Tabuk Pharmaceuticals Partner to Commercialize Moderna’s COVID-19 Vaccine in Saudi Arabia

Friday, June 11, 2021 - 1:30pm

Under the terms of this agreement, Tabuk Pharmaceuticals will hold the marketing authorization for the Moderna COVID-19 vaccine in Saudi Arabia.

Key Points: 
  • Under the terms of this agreement, Tabuk Pharmaceuticals will hold the marketing authorization for the Moderna COVID-19 vaccine in Saudi Arabia.
  • We appreciate the collaboration of Tabuk Pharmaceuticals in this new partnership in Saudi Arabia, said Stphane Bancel, Chief Executive Officer of Moderna.
  • We welcome the opportunity to work with Tabuk Pharmaceuticals to bring the Moderna COVID-19 and potentially other Moderna mRNA products to Saudi Arabia in the future, said Corinne Le Goff, Pharm.D., M.B.A., Chief Commercial Officer of Moderna.
  • Established in Saudi Arabia in 1994, Tabuk Pharmaceuticals is a leading regional pharmaceutical in the Middle East and North Africa (MENA).

Moderna Files for Emergency Use Authorization for its COVID-19 Vaccine in Adolescents in the United States

Thursday, June 10, 2021 - 1:00pm

We are pleased to announce that we have submitted for an emergency use authorization for our COVID-19 vaccine with the FDA for use in adolescents in the United States, said Stphane Bancel, Chief Executive Officer of Moderna.

Key Points: 
  • We are pleased to announce that we have submitted for an emergency use authorization for our COVID-19 vaccine with the FDA for use in adolescents in the United States, said Stphane Bancel, Chief Executive Officer of Moderna.
  • We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents.
  • Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine.
  • Individuals who have received one dose of Moderna COVID-19 Vaccine should receive a second dose of Moderna COVID-19 Vaccine to complete the vaccination series.

Calyx Supports over 100 COVID-19 Vaccine Authorizations

Thursday, June 10, 2021 - 12:55pm

To date, over 100 COVID-19 vaccine authorizations have been granted by worldwide regulatory bodies based on clinical trial data submitted via Calyx's proven Regulatory Information Management (RIM) system.

Key Points: 
  • To date, over 100 COVID-19 vaccine authorizations have been granted by worldwide regulatory bodies based on clinical trial data submitted via Calyx's proven Regulatory Information Management (RIM) system.
  • Global pharmaceutical companies repeatedly rely on Calyx RIM for critical regulatory submissions.
  • "We are so proud of the role Calyx has played in the world's fight against the COVID-19 pandemic," said Gavin Nichols, CEO of Calyx.
  • For the COVID-19 vaccine authorizations, Calyx's expert regulatory teams provided dedicated, on-call 24x7 support to ensure optimal efficiency throughout the rolling reviews of these compressed publishing windows.

Calyx Supports over 100 COVID-19 Vaccine Authorizations

Thursday, June 10, 2021 - 12:55pm

To date, over 100 COVID-19 vaccine authorizations have been granted by worldwide regulatory bodies based on clinical trial data submitted via Calyx's proven Regulatory Information Management (RIM) system.

Key Points: 
  • To date, over 100 COVID-19 vaccine authorizations have been granted by worldwide regulatory bodies based on clinical trial data submitted via Calyx's proven Regulatory Information Management (RIM) system.
  • "We are so proud of the role Calyx has played in the world's fight against the COVID-19 pandemic," said Gavin Nichols, CEO of Calyx.
  • For the COVID-19 vaccine authorizations, Calyx's expert regulatory teams provided dedicated, on-call 24x7 support to ensure optimal efficiency throughout the rolling reviews of these compressed publishing windows.
  • Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably.

Statement from the Chief Public Health Officer of Canada on June 8, 2021

Tuesday, June 8, 2021 - 7:14pm

At the same time, the Public Health Agency of Canada is providing Canadians with regular updates on COVID-19 vaccines administered , vaccination coverage and ongoing monitoring of vaccine safety across the country.

Key Points: 
  • At the same time, the Public Health Agency of Canada is providing Canadians with regular updates on COVID-19 vaccines administered , vaccination coverage and ongoing monitoring of vaccine safety across the country.
  • They also tell us, together with results of serological studies, that a large majority of Canadians remain susceptible to COVID-19 .
  • As immunity is still building up across the population, public health measures and individual precautions are crucial for COVID-19 control.
  • Working together, Health Canada , the Public Health Agency of Canada , the National Advisory Committee on Immunization , Canada's Chief Medical Officers of Health and other health professionals across the country are closely monitoring vaccine safety , effectiveness and optimal use to adapt approaches.

Icosavax Initiates Phase 1/2 Trial of COVID-19 VLP Vaccine Candidate

Tuesday, June 8, 2021 - 2:00pm

We are pleased to be working with Seqirus to evaluate MF59 in combination with IVX-411, our COVID-19 VLP vaccine candidate.

Key Points: 
  • We are pleased to be working with Seqirus to evaluate MF59 in combination with IVX-411, our COVID-19 VLP vaccine candidate.
  • The Phase 1/2 clinical trial is a randomized, observer-blinded, placebo-controlled trial designed to evaluate the safety and immunogenicity of adjuvanted and unadjuvanted IVX-411.
  • The Phase 2 part of the trial will enroll SARS-CoV-2 seropositive adults who have completed a vaccine regimen using a licensed COVID-19 vaccine.
  • Icosavax is advancing VLP vaccine candidates against respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and SARS-CoV-2 (COVID-19).

AGC Biologics’ Heidelberg Facility to Further Supply Plasmid DNA for COVID-19 Vaccine

Monday, June 7, 2021 - 3:06pm

Seattle, June 07, 2021 (GLOBE NEWSWIRE) -- AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has announced its partnership with BioNTech SE (Nasdaq BNTX) to further supply Plasmid DNA (pDNA) starting material for the Pfizer-BioNTech COVID-19 vaccine, at AGCs Heidelberg, Germany facility.

Key Points: 
  • Seattle, June 07, 2021 (GLOBE NEWSWIRE) -- AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has announced its partnership with BioNTech SE (Nasdaq BNTX) to further supply Plasmid DNA (pDNA) starting material for the Pfizer-BioNTech COVID-19 vaccine, at AGCs Heidelberg, Germany facility.
  • AGC Biologics will manufacture and supply BioNTech with pDNA starting material, an essential component of BioNTechs mRNA-based vaccine manufacturing process.
  • The team at Heidelberg is enthusiastically embracing this important project with BioNTech, says AGC Biologics General Manager, Heidelberg, Dieter Kramer.
  • AGC Biologics Heidelberg facility has over 20 years of experience delivering a very wide range of microbial programs for our customers.