#20446
Re: Novavax (NVAX): Un Nuevo Comienzo
Vía IV, respuesta del tga Australia. Ahora tiene más sentido lo del otro día.
NVAX registró el 29 oct y el 8 de nov cambió algunos datos referentes a la calidad de producción. El 10 del tga hizo muchas (u específicas) preguntas acerca de los datos y están esperando la respuesta de la empresa.
NVAX registró en WHO el 4 de noviembre, puede que de los datos de ahí actualizara otras aplicaciones.
TGA está de los últimos en la lista, así que no sé cuánto tardarán en contestar y por supuesto si está todo como debe (que sería lo suyo pero nunca se sabe).
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NVAX registró el 29 oct y el 8 de nov cambió algunos datos referentes a la calidad de producción. El 10 del tga hizo muchas (u específicas) preguntas acerca de los datos y están esperando la respuesta de la empresa.
NVAX registró en WHO el 4 de noviembre, puede que de los datos de ahí actualizara otras aplicaciones.
TGA está de los últimos en la lista, así que no sé cuánto tardarán en contestar y por supuesto si está todo como debe (que sería lo suyo pero nunca se sabe).
--
Australian Novovax discussion group
Email received this morning re Novavax and TGA from Professor John Skerritt's office and have included the first parts specifically relating to Novavax: My warmest wishes to you all...
Thank you for your email concerning the Novavax COVID-19 vaccine.
On 29 October 2021 the TGA received the submission for the Novavax COVID-19 vaccine, however Novavax subsequently withdrew elements of that submission and replaced it with new parts of the submission relating to product quality on 8 November. Our team immediately reviewed the new data and on 10 November 2021 responded to Novavax as we had a number of significant and specific questions around the data. We await their response.
We are in very regular contact with Novavax but the timeframes for responding to TGA’s questions are now in their hands and not ours. The timeframes of any final approval very much depend on how quickly and how completely the applicant responds to the questions that regulators such as the TGA have on their submission. Be assured that immediately we receive the required responses from Novavax we will review the responses and if the responses are adequate progress the application with the utmost urgency.
The TGA can only make a regulatory decision once the complete information on the safety, efficacy (how well it works) and manufacturing quality of the vaccine has been provided by the company. We undertake a rigorous evaluation process to ensure all COVID-19 vaccines meet stringent safety and efficacy guidelines and comply with exacting manufacturing and production standards. As part of this process sponsors are required to submit a comprehensive dossier, including clinical trial data, non-clinical toxicology studies, and chemistry, risk management and manufacturing information.
At this point, the Novavax COVID-19 vaccine has not received regulatory approval in any developed country world-wide. This means that we will not be able to use completed reviews from other comparable regulators such as the UK or Canada to facilitate the TGA’s review.
Thank you for your email concerning the Novavax COVID-19 vaccine.
On 29 October 2021 the TGA received the submission for the Novavax COVID-19 vaccine, however Novavax subsequently withdrew elements of that submission and replaced it with new parts of the submission relating to product quality on 8 November. Our team immediately reviewed the new data and on 10 November 2021 responded to Novavax as we had a number of significant and specific questions around the data. We await their response.
We are in very regular contact with Novavax but the timeframes for responding to TGA’s questions are now in their hands and not ours. The timeframes of any final approval very much depend on how quickly and how completely the applicant responds to the questions that regulators such as the TGA have on their submission. Be assured that immediately we receive the required responses from Novavax we will review the responses and if the responses are adequate progress the application with the utmost urgency.
The TGA can only make a regulatory decision once the complete information on the safety, efficacy (how well it works) and manufacturing quality of the vaccine has been provided by the company. We undertake a rigorous evaluation process to ensure all COVID-19 vaccines meet stringent safety and efficacy guidelines and comply with exacting manufacturing and production standards. As part of this process sponsors are required to submit a comprehensive dossier, including clinical trial data, non-clinical toxicology studies, and chemistry, risk management and manufacturing information.
At this point, the Novavax COVID-19 vaccine has not received regulatory approval in any developed country world-wide. This means that we will not be able to use completed reviews from other comparable regulators such as the UK or Canada to facilitate the TGA’s review.
