72.6 F
New York
Monday, May 17, 2021

Pfizer-BioNTech Plans to Expand Conditional Marketing Authorization of COMIRNATY

Must read

Oaktree [NASDAQ: OCSL] Announces Pricing of Underwritten Public Offering

Oaktree Specialty Lending Corporation disclosed that it has set the price of an underwritten public offering of $350.0 million aggregate principal amount of...

Black.one Introduces Cryptocurrency Exchange Venture with $10B in Funding

Black.one has disclosed Tuesday that it has launched Bullish Global. Bullish Global is a subsidiary of Black.one. It is a new blockchain-based cryptocurrency exchange...

Pfizer-BioNTech COVID-19 Vaccine Gets FA Approval for Emergency Use in Adolescents

Pfizer Inc. and BioNTech SE disclosed that its COVID-19 vaccine has got the FDA approval for its COVID-19 vaccine. After the approval,...

Soliton [NASDAQ: SOLY] to be Acquired by Allergan Aesthetics

Soliton, Inc. disclosed Monday that it has inked an agreement with Allergen Aesthetics. As per the agreement, Allergen Aesthetics will buy Soliton. Allergen...

Pfizer Inc. [NYSE: PFE] and BioNTech SE [NASDAQ: BNTX] disclosed that it has decided to submit a change to the Conditional Marketing Authorization (CMA) in the EU to the EMA for the Pfizer-BioNTech vaccine COMIRNATY (BNT162b2) to ask for a delay of the suggestion for use in adolescents 12 to 15 years of age.

It has been disclosed that if the modified version of CMA will be authorized by EMA then it will be valid in all the 27 member states of the EU. Furthermore, the firms have already filed a related application to the U.S. FDA for the EUA. Moreover, it is planning to ask for further changes with other regulatory agencies around the world.

Additionally, it has been uncovered by the firms that their submission is dependent on the pivotal Phase III clinical study. The Phase III study has registered 2,260 applicants aged 12 to 15 years. Earlier on March 31, 2021, the firms have revealed the results of the study. The outcome of the study indicated the 100% potency in volunteers with or without before SARS-CoV-2 infection and vigorous antibody responses.

Furthermore, the volunteers have also easily tolerated the vaccine. The firm has decided to monitor the volunteers for safety for an extra two years after their second dose. The Pfizer-BioNTech’s vaccine is based on BioNTech patented mRNA technology. It was established by both BioNTech and Pfizer. Moreover, BioNTech is the possessor of MA in the EU. It also holds emergency use authorizations or equivalent in the UK, Canada, and the US.

More articles

Latest article

Elon Musk’s SpaceX to Roll Out Dogecoin-Backed Satellite to the Moon in 2022

Elon Musk’s SpaceX has decided to recognize Dogecoin as payment to roll out its “DOGE-1 Mission to the Moon”. The mission is going to...

SBI CEO Yoshitaka Kitao Reveals Ripple to Go Public after its Legal Battle with the SEC is Over

CEO of Japanese financial services company SBI Holdings, Yoshitaka Kitao disclosed that Ripple has opted for an option to go public once its legal...

Coinbase Pro Announces it will be Listing Internet Computer’s ICP

Coinbase Pro cryptocurrency exchange has disclosed that it has decided to list ICP once it goes live. ICP is the governance token of the...

WISeKey [NASDAQ: WKEY] Gets Investment to finance its TrustNFT.IO NFT Platform

WISeKey International Holding AG disclosed Friday that it has inked a term-sheet to enter into an unsecured short-term loan and the issuance and...

Moderna [NASDAQ: MRNA] Inks Supply Agreement with Switzerland

Moderna, Inc. disclosed that it has inked a supply agreement on Thursday with the Swiss Federal Government. As per the agreement, Moderna Inc...

TeraBlock Will Have its Own BSCPad IDO Soon

TeraBlock which is a project making a platform for automated cryptocurrency portfolio management disclosed that it is preparing for an initial DEX offering (IDO)...

Why Chiasma [NASDAQ: CHMA] Stock is Skyrocketed?

Shares of Chiasma, Inc. surged 46.48% during the trading session of Wednesday. Chiasma has disclosed the financial results for the Q1 completed March...

NeoGenomics [NASDAQ: NEO] Announces Acquisition of Inivata Ltd

NeoGenomics, Inc. revealed Wednesday that it has decided to purchase Inivata Ltd. Inivata will grow into a liquid biopsy-centered division together with increasing...