COVID-19 vaccine development pipeline gears up

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Vacunas contra el Covid-19. Cuáles llegarán a la Argentina y qué resultados se esperan

Vacunas contra el Covid-19. Cuáles llegarán a la Argentina y qué resultados se esperan

www.lanacion.com.ar

2 December 2020
....During the application operation in Argentina, which is estimated to begin in January, the first to receive the vaccine will be those over 60 years of age, health, security and defense personnel, teachers and the population with pre-existing diseases that may aggravate the evolution of Covid-19.

The Argentine government signed an agreement to purchase the one developed by the University of Oxford and is holding advanced talks to acquire the Russian one, the one from Pfizer and the one from Johnson & Johnson. In addition to the negotiations with the different countries, the Alberto Fernández administration joined the Covax mechanism, led by the World Health Organization and paid an advance to obtain nine million vaccines....

....Based on the vaccines that the WHO indicates as the most auspicious, LA NACION shows in detail the characteristics of each one, from the effectiveness to the reported price. Beyond the official value, each country can open negotiations with the companies in charge of vaccines when reserving them....

 

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Streamed live on 2 December 2020...
Russia's Health Minister, Mikhail Murashko, provides details on the Sputnik V at the United Nations. Sputnik V is the world's first registered COVID-19 vaccine by Russia, registering 95-percent efficacy, according to a second interim analysis of clinical trial data on November 24.

 

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Coronavirus: tras la aprobación en Inglaterra, Pfizer presentó el pedido de autorización en la Anmat

Coronavirus: tras la aprobación en Inglaterra, Pfizer presentó el pedido de autorización en la Anmat

www.lanacion.com.ar

2 December 2020
A few hours after the authorities of the United Kingdom gave the green light to the pharmaceutical company Pfizer and BioNTech, the laboratories presented the request to the National Administration of Medicines, Food and Medical Technology (ANMAT) for approval in Argentina.

As LA NACION learned from official sources, the vaccine, which reported 95% effectiveness among the volunteers who were inoculated, began today the formal process to obtain an emergency approval and begin to be applied in the country.

It is the third vaccine against the SARS-CoV-2 virus that began the approval process in the country....The other two vaccines that are being analyzed by the ANMAT...AstraZeneca and Sputnik V....

Sources accustomed to the approval processes of drugs and vaccines before the ANMAT consulted by LA NACION explained: "Normally it is expected to have the results of Phase 3 to start this process or that it is approved by the Office of Drugs and Food (FDA) or the European Medicines Agency (EMA) ". "This is an exceptional situation, so there are many things that we do not know. Until now, the ANMAT never approved something on its own, without prior approval by some larger entity such as the World Health Organization, the FDA or the EMA" , they detailed.

 

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Coronavirus: tras la aprobación en Inglaterra, Pfizer presentó el pedido de autorización en la Anmat

Coronavirus: tras la aprobación en Inglaterra, Pfizer presentó el pedido de autorización en la Anmat

www.lanacion.com.ar

2 December 2020
A few hours after the authorities of the United Kingdom gave the green light to the pharmaceutical company Pfizer and BioNTech, the laboratories presented the request to the National Administration of Medicines, Food and Medical Technology (ANMAT) for approval in Argentina.

As LA NACION learned from official sources, the vaccine, which reported 95% effectiveness among the volunteers who were inoculated, began today the formal process to obtain an emergency approval and begin to be applied in the country.

It is the third vaccine against the SARS-CoV-2 virus that began the approval process in the country....The other two vaccines that are being analyzed by the ANMAT...AstraZeneca and Sputnik V....

Sources accustomed to the approval processes of drugs and vaccines before the ANMAT consulted by LA NACION explained: "Normally it is expected to have the results of Phase 3 to start this process or that it is approved by the Office of Drugs and Food (FDA) or the European Medicines Agency (EMA) ". "This is an exceptional situation, so there are many things that we do not know. Until now, the ANMAT never approved something on its own, without prior approval by some larger entity such as the World Health Organization, the FDA or the EMA" , they detailed.

Too many vaccines, dates, groups to receive it. A chart would be helpful.

 

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Too many vaccines, dates, groups to receive it. A chart would be helpful.

The ANMAT normally is expected to have the results of Phase 3 to begin the process of approval, or for the vaccine to be approved by the Food and Drug Office (FDA) or the European Medicines Agency (EMA). The process of approval has yet to start in ARG. So far there are only 3 vaccines in the running.

Vacunas para SARS-CoV-2 con documentación en proceso de presentación para su registro

ANMAT pone a disposición la lista de titulares que han comenzado a presentar documentación para el registro de la vacuna para SARS-CoV-2.

www.argentina.gob.ar

Posted on Wednesday, December 02, 2020
ANMAT Updated list of product holders that have begun to submit the necessary documentation for the registration of their vaccine for SARS-CoV-2:

PFIZER SRL, name: SARS-COV-2 RNA VACCINE....Start date of documentation submission: December 02, 2020

HLB Pharma Group, name: SPUTNIK V
Start date for submission of documentation: November 02, 2020

Astra Zéneca SA, name AZD-1222
Documentation submission start date: October 05, 2020

As far as "groups to receive it"....let us wait until the gov't officially announces it has the vaccine(s) in hand and the actual number of dose obtained on the first round. On November 24, the gov't stated "initially there will be 12,063,000 people vaccinated, which includes those over 60 and essential personnel from different areas". In my opinion, those figures are overconfident. I don't believe they will have that many dose at the start of the campaign. Some believe "250,000 or perhaps at best 500,000".

 

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Vacuna Sputnik V: Rusia asegura que se podría producir en la Argentina

Lo ratificaron autoridades de la empresa a cargo del desarrollo. Se trata de la vacuna más barata presentada hasta ahora.

www.ambito.com

2 December 2020
....The Russian government announced on Wednesday the official launch of the Sputnik V vaccine and confirmed that Argentina will be able to participate in the production locally, as confirmed by the Russian authorities during an exhibition at the United Nations....

....the one who confirmed Argentina's participation in the production of the vaccine was the general director of the Russian Direct Investment Fund (RDIF), Kirill Dmitriev, the company in charge of its development....The possibility of participating in the production process will guarantee Argentina to reduce costs and increase access to the vaccine....

 

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Alberto Fernández: “Vamos a poder vacunar a 300.000 personas antes de fin de año”

El presidente Alberto Fernández confirmó este jueves que el Gobierno nacional tiene previsto vacunar a 300.000 personas contra el coronavirus antes de fin de año con la vacuna rusa.

www.airedesantafe.com.ar

3 December 2020 at 11:35am
....President Alberto Fernández revealed this Thursday that the national government will sign "this week" the contract with Russia to receive the 'Sputnik V' vaccines and announced that it is expected to "vaccinate 300,000 people before the end of the year."
....“I have already read the last contract and it is ready to be signed. We will do it between today, tomorrow or the day after, "said the President....
....Meanwhile, he confirmed that "5 million people will be vaccinated during January and another 5 million in February."....

....Regarding the vaccination campaign, the President said that Argentines “must do an epic during the summer, trying first to vaccinate those who are most at risk, health personnel, security personnel, teachers, people over 60 years of age and those with prevalent diseases, "which would be" about 13 million people."

Finally, he specified that "in March we will receive the vaccine from AstraZeneca and Oxford" and added: "We hope to also receive the one from Pfizer."

 

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Coronavirus: Hackers targeted Covid vaccine supply 'cold chain'

IBM says organisations involved in moving coronavirus vaccines at chilled temperatures were targeted.

www.bbc.com

 

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UPDATE: 3 December 2020 at 4:23pm

Ginés puso en duda la vacunación a 300 mil personas antes de fin de año

El ministro de Salud contradijo al presidente y dijo que no cree que se llegue a tiempo para la fecha que había estimado esta mañana Alberto Fernández.

www.perfil.com

The Minister of Health, Gines Gonzalez Garcia, questioned the assertion that the Government can vaccinate "300,000 persons
before the end of the year" with the Russian vaccine Sputnik V, as stated this morning by the President Alberto Fernandez....
A couple of hours later, Gonzalez Garcia was asked about the announcement, but the Minister made it clear that he does not believe that it will arrive in time for the date that the President estimated. "The work has been going for months, how we bring the vaccine, how it comes....and such things. The logistical challenge is very great. Furthermore, we want it to be simultaneous and equitable," explained the health official. "There is an idea of having vaccines before the end of the year. Obviously if we have vaccines there is that chance", he stressed. The President is busy, worried, obsessed and that makes us want to start vaccination quickly," concluded Gonzalez Garcia....

 

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La conexión local de la vacuna rusa Sputnik V: qué laboratorios podrían producirla en la Argentina

Algunos de los desafíos cruciales en la fabricación de las vacunas contra el COVID-19 que enfrentan hoy los laboratorios, giran alrededor de evaluar la producción en distintos puntos del globo, y apuntar a los organismos de control local -mientras se expiden los dos sellos más importante del...

www.infobae.com

3 December 2020
....What laboratory has the capacity in Argentina to produce the Russian Sputnik V vaccine? And what is needed to produce vaccines of these characteristics?
....In dialogue with Infobae Fernando Lobos, director of the biotechnology company Sinergium Biotech explained, "to produce a vaccine like the Russian one, bioreactors of five hundred, thousand or two thousand liters of stainless steel or disposable technology are needed. And some process of purification with filters or chromatography. It is a fairly standard facility for the production of proteins in bioreactors ”....

"In Argentina, the Insud Group has these technologies available in one of the group companies, mAbxcience, which, as we already know, is the local laboratory in charge of producing the fundamental reagent for the Oxford-AstraZeneca vaccine for the entire region, technology similar to the Russian vaccine ”....There are other laboratories in Argentina that have the availability of scientific resources, biotechnology transfer and facilities such as Biosidus; o Gema Biotech, located in the province of Santa Fe, and which is also dedicated to the production of monoclonal antibodies.

Then we will have to think about the stage of formulation and filling of the Sputnik V vaccine, which in the Argentine case could be done in the biotech Sinergium or HLB Pharma, which still seems to keep the registration of the Russian vaccine before the ANMAT.
About the HLB Pharma laboratory - which raised so much controversy, even from the national authorities - as Infobae learned, in the documentation presented to the ANMAT on the Sputnik V vaccine, it still appears with the Russian vaccine registry. And although it is likely that it will be left out of the commercialization of the 25 million doses of the Russian vaccine against the coronavirus that Argentina reserved, it cannot be ruled out that it could participate in some process of finishing the product....