RNA vaccines

U.S. Government Purchases Additional 200 Million Doses of Moderna’s COVID-19 Vaccine

Retrieved on: 
Wednesday, June 16, 2021

Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the U.S. government has purchased an additional 200 million doses of Modernas COVID-19 vaccine, including the option to purchase other COVID-19 vaccine candidates from Modernas pipeline.

Key Points: 
  • Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the U.S. government has purchased an additional 200 million doses of Modernas COVID-19 vaccine, including the option to purchase other COVID-19 vaccine candidates from Modernas pipeline.
  • As of June 14, Moderna has supplied 217 million released doses of the vaccine to the U.S. government.
  • The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein.
  • Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Moderna COVID-19 Vaccine.

Direct Relief Facilitates Donations of 1.75 Million COVID-19 Vaccine Doses to Mexico, Belize, Bolivia and Paraguay

Retrieved on: 
Tuesday, June 15, 2021

The deliveries include 1.35 million doses from the U.S. to Mexico and a total of 400,000 doses from Mexico to Belize, Bolivia and Paraguay.

Key Points: 
  • The deliveries include 1.35 million doses from the U.S. to Mexico and a total of 400,000 doses from Mexico to Belize, Bolivia and Paraguay.
  • A FedEx flight arrived today at Toluca International Airport near Mexico City with 1.35 million doses of Johnson & Johnson's single-dose COVID-19 vaccine.
  • The U.S. government sent the vaccine to Mexico with support from Direct Relief, which arranged to fly the doses from the U.S. to Mexico via its longstanding relationship with FedEx.
  • Since January 2020, Direct Relief has provided 38 million doses of temperature-sensitive medication requiring refrigerated shipping to 60 countries.

Moderna and Magenta Partner to Distribute Moderna’s COVID-19 Vaccine and Updated Variant Booster Candidates in United Arab Emirates

Retrieved on: 
Tuesday, June 15, 2021

We welcome the opportunity to work alongside Magenta for the distribution of our vaccine in the UAE, said Corinne Le Goff, Pharm.D., M.B.A., Chief Commercial Officer of Moderna.

Key Points: 
  • We welcome the opportunity to work alongside Magenta for the distribution of our vaccine in the UAE, said Corinne Le Goff, Pharm.D., M.B.A., Chief Commercial Officer of Moderna.
  • Magenta is fully committed to supporting the efforts of the government of the United Arab Emirates in its monumental efforts to contain the pandemic, said Dr. Zahid Al Sabti, Managing Director of Magenta Investments.
  • I am delighted to see Magenta entering this strategic partnership with Moderna and contributing to the ongoing battle against the pandemic.
  • On May 12, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation.

Moderna Submits Authorization Application for its COVID-19 Vaccine in Adolescents in Switzerland

Retrieved on: 
Monday, June 14, 2021

We are pleased to announce that we have submitted an authorization application for our COVID-19 vaccine with Swissmedic for use in adolescents in Switzerland, said Stphane Bancel, Chief Executive Officer of Moderna.

Key Points: 
  • We are pleased to announce that we have submitted an authorization application for our COVID-19 vaccine with Swissmedic for use in adolescents in Switzerland, 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.
  • In the study, no cases of COVID-19 were observed in participants who had received two doses of the Moderna COVID-19 vaccine using the primary definition.
  • The vaccine efficacy in the nearly 2,500 adolescents who received the Moderna COVID-19 vaccine was observed to be 100% when using the same case definition as in the Phase 3 COVE study in adults.

Global WholeHealth Partners Corp. (GWHP-OTC) Acquires Rights to Distribute & Sell Johnson & Johnson COVID-19 Vaccine

Retrieved on: 
Monday, June 14, 2021

The Company has recently filed an 8K stating that: Effective June 9, 2021, Global WholeHealth Partners Corporation (the Company) was granted the rights from Nunzia Pharmaceutical Inc. (Nunzia) to distribute and sell the Johnson & Johnson COVID-19 Vaccine (Vaccine).

Key Points: 
  • The Company has recently filed an 8K stating that: Effective June 9, 2021, Global WholeHealth Partners Corporation (the Company) was granted the rights from Nunzia Pharmaceutical Inc. (Nunzia) to distribute and sell the Johnson & Johnson COVID-19 Vaccine (Vaccine).
  • As of April 20, 2021, Johnson & Johnsons Covid-19 vaccine contributed $100 million to J&Js sales growth in the latest quarter.
  • [1] J&J said its pharmaceutical business, which developed the single-shot Covid-19 vaccine, generated $12.19 billion in revenue, a 9.6% year-over-year increase.
  • Investors and security holders are urged to read these documents free of charge on the SEC's web site at http://www.sec.gov .

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

Retrieved on: 
Saturday, June 12, 2021

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

Retrieved on: 
Friday, June 11, 2021

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

Retrieved on: 
Friday, June 11, 2021

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

Retrieved on: 
Friday, June 11, 2021

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

Retrieved on: 
Thursday, June 10, 2021

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.