COVID-19 vaccine development pipeline gears up

[gracielle]

¿Cuándo llega mi turno para vacunarme? ¿Qué efectos son esperables? ¿Se aplicarán en chicos?

¿Cuándo llega mi turno para vacunarme? ¿Qué efectos son esperables? ¿Se aplicarán en chicos?

www.lanacion.com.ar

27 January 2027
Guide of Vaccines....The answers to all your questions about vaccination against coronavirus.
....Questions multiply and information does not always reach citizens clearly. LA NACION prepared an interactive guide with answers to the most frequent questions about vaccination....

 

[gracielle]

Inmunidad en camino: quiénes integran el grupo privilegiado de argentinos que están recibiendo la vacuna de Pfizer

Son los que participaron del ensayo de la firma en la Argentina. Los que recibieron placebo están siendo llamados para recibir la vacuna en el Hospital Militar. Coronavirus en Argentina: confirman otras 182 muertes y 10.843 nuevos casos en las últimas 24 horas País por país: en vivo el mapa de...

www.clarin.com

27 January 2021....behind paywall.
Coronavirus: Immunity on the way: who is part of the privileged group of Argentines who are receiving the Pfizer vaccine. They are the ones who participated in the trial of the firm in Argentina. Those who received placebo are being called in to receive the vaccine at the Military Hospital.

The pharmaceutical company is "opening the envelopes", first of all, to those who belong to the risk groups of Covid-19. They inform them whether during the study they received two doses of the vaccine or, conversely, two doses of placebo. If they didn't get the immunization, they can go to the hospital and get it. In a statement sent to all participants, Pfizer clarified that those who do not belong to the risk groups will have the same opportunity to be invited to receive the vaccine, if they previously received placebo....

....How was the clinical trial. Some 6,000 Argentines between the ages of 18 and 85 were selected to participate in the clinical trial, from 20,000 volunteers registered in an online form. The study - coordinated by researcher Fernando Polack - provides for the follow-up of patients for two years with scheduled meetings at the Military Hospital. In total, each participant will make about six visits. Only half of the participants received the vaccine. The other half got a placebo, which is a substance without therapeutic action. This is a “double-blind” study, since neither doctors nor patients know who gets what. That gives the test more objectivity. Volunteers do not receive money. They are covered with exclusive medical insurance, something they sign together with the consent. And they can leave the study whenever they want.

To carry out this program, more than 700 people work in medical care, daily consultations and transfers of volunteers from home to the Military Hospital and vice versa. They received special training for this study.

 

[jeff1234]

Is there a way to register to be vaccinated with the Pfizer vaccine?

 

[gracielle]

Is there a way to register to be vaccinated with the Pfizer vaccine?

NO....currently Pfizer has not signed a contract with ARG to provide their vaccine here. The main reason being that Pfizer requires of any purchasing country to utilize DHL as their aircrafts are prepared to handle the temperature required to transport their vaccine.

 

[gracielle]

Sputnik V: el avión de Aerolíneas Argentinas traerá menos de la mitad de las dosis prometidas por Rusia

Sputnik V: el avión de Aerolíneas Argentinas traerá menos de la mitad de las dosis prometidas por Rusia

www.lanacion.com.ar

27 January 2021
Sputnik V: Aerolineas Argentinas plane will bring less than half of the doses promised by Russia. The plane will load 220,000 doses of the vaccine in Moscow today and not 600,000, as had been initially reported. Source: Télam

The delayed third flight of Aerolineas Argentinas to the Russian Federation in search of more Sputnik V vaccines will arrive this afternoon in Moscow. In the midst of versions, the shipment that will return to Buenos Aires tomorrow will not finally be 600,000 doses, as had been announced, but 220,000; that is, less than half of what had been agreed just a few days ago with the government of Vladimir Putin. The Gamaleya Institute itself took responsibility, with the plane in Russian territory, of the "delays" in the provision of vaccines, but assured that Argentina "will continue to receive" the agreed doses.

"There are 220 thousand on this flight and they guarantee a permanent flow, flights will continue to come and go," they confirmed today to LA NACION sources very close to President Alberto Fernández. The Ministry of Health specified hours later that it was about 110,000 first doses, and another 110,000 of the second antidote...

...."The vaccines are there, but delivery is being delayed. But they will arrive shortly," they commented yesterday from the delegation accompanying President Alberto Fernández on his state visit to Chile. After a day of uncertainty, the flight departed from Ezeiza last night, but doubt remains about the content that will arrive in Buenos Aires. "We will know when the crew gets there," another source familiar with the operation told LA NACION....

 

[gracielle]

Johnson & Johnson Covid vaccine results 'next week': CFO

Johnson & Johnson expects to report results from the eagerly-anticipated clinical trial of its COVID-19 vaccine next week, the US pharmaceutical's chief financial officer told CNBC Tuesday.

medicalxpress.com

 

[artisans]

It's interesting the significant difference in tone and detail in reporting between Pagina12 versus La Nacion & Infobae
Russia guaranteed the supply of Sputnik V to Argentina
The definition comes at a time of global tension due to the high demand for vaccines
The Russian Fund for Direct Investment and the Gamaleya Center highlighted the "solid alliance" they established with the country. They specified that that is why the vaccine "will continue to receive" more than the difficulties that its large-scale production presents and possible delays. Tomorrow more doses arrive from Moscow.
During the last days, some media wanted to attribute the delays in the arrival of the Russian vaccine to "Argentine logistical problems . " However, this Wednesday the head of the RDIF explained that "vaccine production has many components and if there are problems with one, everything is delayed," acknowledging that the delays are the responsibility of Russian production.
This situation is being repeated with the different vaccines of the world: while Pfizer argued that the delays in the delivery of doses are due to the fact that it is expanding its plant in Belgium, Oxford-AstraZeneca announced that it will only start supplying the doses in mid-February. .

Rusia garantizó el suministro de las Sputnik V a la Argentina | La definición llega en un momento de tensión mundial por la alta demanda de las vacunas

El Fondo Ruso de Inversión Directa y el Centro Gamaleya destacaron la “sólida alianza” que establecieron con el país. Precisaron que por eso “seguirá recibiendo” la vacuna más de las dificultades que presenta su producción a gran escala y posibles retr...

www.pagina12.com.ar

 

[gracielle]

Sputnik V: Cuál fue el rol de la empresa rusa que participó en la compra de las 50 millones de dosis

Se trata de una sociedad creada para vender la vacuna; también fue parte de las negociaciones un laboratorio argentino

www.lanacion.com.ar

PART 1:
27 January 2021....by Fabiola Czubaj, Iván Ruiz and Delfina Arambillet with the collaboration of Ricardo Brom.
Sputnik V: What was the role of the Russian company that participated in the purchase of the 50 million doses.
It is a company created to sell the vaccine; an Argentine laboratory was also part of the negotiations.

The negotiations between Argentina and Russia for the purchase and distribution of the vaccine for the new coronavirus had two companies as privileged witnesses. A Russian company, created to sell the Sputnik V vaccine, appeared as an intermediary between the government of that country and the Ministry of Health of the Nation, according to the contract data confirmed by LA NACION. And another company, this one Argentine, sat at the negotiating table, having previously lifted a call by creditors, and requested the ANMAT to register the product for its commercialization.

The official contract reveals the intermediation of a Russian company. For Argentina, the signature of Minister Ginés González García appears. By the seller, Human Vaccines LLC, a limited liability firm with no declared employees or business background that was registered last year in the Russian register of companies Egrul and is managed by the corporate center of the Russian Direct Investment Fund (RDIF, for its acronym in English). This arises from the information that the ruling party shared in Congress about this confidential contract and that was confirmed by the RDIF. Also, the company is mentioned in the opinion of the General Directorate of Legal Affairs of the Ministry of Health on December 23, as revealed by LA NACION.



Translation from Russian of the registration of the Human Vaccine signature in the Unified State Register of Legal Entities of Russia.

The contract was signed with the Russian company for the provision of 20 million doses - with the possibility of expanding to 30 million - of the product developed by the Gamaleya National Research Center for Epidemiology and Microbiology. It was not strictly an agreement "between States", as officials, legislators and spokesmen of the ruling party tend to agree to justify the confidentiality of its content. As representative of Human Vaccines LLC signed Alexander Chistyakov, a businessman with no experience in the healthcare sector. He is currently President of RusPetro Ltd, an oil and geological development company. From Moscow, a source close to the negotiation specified that Chistyakov's signing of the contract "is just a technicality", since although he is a high-ranking employee, he is not the one who makes the decisions at the firm. LA NACION tried to contact the businessman through his corporate account and received no response.

The team of the online newspaper Meduza, from Russia, which covers vaccination in that country, explained about the operation of the companies in accordance with local legislation that Human Vaccine is a subsidiary of the RDIF with no business declared with the Russian state or assigned personnel. "Alexander Chistyakov is a high-ranking employee of the RDIF (he is the CEO of the Corporate Center that owns Human Vaccine) and, according to fund sources, participated in the signing of the contract in one of the steps of the transaction," they indicated from that medium.

The Gamaleya National Research Center for Epidemiology and Microbiology, which developed the vaccine, depends on the Ministry of Health of the Russian Federation and the RDIF was appointed to distribute the production of Sputnik V by different companies inside and outside the country. In order to sign international contracts, the RDIF created a company. The Argentine purchase was closed through that company domiciled in Moscow, as indicated by the copy of its official registration. This agreement is considered "reserved" in the vaccine approval file in the country.

Among the data of the contract that the ruling party provided in the Chamber of Deputies, the United Kingdom appears as the jurisdiction chosen between the parties for the resolution of any conflict that may be prosecuted. Two sources with access to the contract without erasures affirmed that the State will pay US$10.00 per dose or component. Thus, Argentina should disburse at least $200 million dollars.

“You can establish some kind of confidentiality during the negotiation, that is reasonable, but then the citizen has to know how much the State is spending, especially in this case that we are talking about public health. The data on the cost of the vaccine must be public so that it is possible to know if it is being bought well or not. Under a confidentiality clause, absolutely everything cannot be hidden, ”said Pablo Secchi, executive director of the Poder Ciudadano Foundation.

What the Government did report are the costs of the second trip to Russia, key for the local approval of Sputnik V. The delegation, which was commanded by the Secretary for Access to Health, Carla Vizzotti, this time included four agents from the ANMAT: Emilia Ojeda Zachara, María Margarita Esnaola, Inés Rizzo and Graciela Testa. Each one, according to ANMAT, received about US$2,800 to cover travel expenses and accommodation. The change of the Air France tickets to business class should have been a relief with more than 18 hours of flight with a stopover between Buenos Aires and Moscow.

Side agreements....The signing of a contract that allows the landing of Sputnik V in Argentina opened parallel negotiations, which included two trips to Russia and meetings of officials with businessmen. When Minister González García had not yet signed the current contract with the Russians, the local laboratory HLB Pharma Group assured in October before Justice that it had signed an agreement for the purchase and distribution of 50 million doses of the vaccine for Argentina and other countries in the region through a joint venture with the corporate center of the Russian Direct Investment Fund (RDIF, for its acronym in English).

The note presented to the Commercial Justice, which this newspaper accessed, sought that the firm, which pre-registered in May last year as a State supplier of drugs and hospital supplies, cancel a debt of almost $8 million in a preventive contest. Once the numbers were in order, they could enter the Sputnik V business that included, in addition to the exclusive representation of the product in the country, its production in Argentina. HLB Pharma was one step away from closing its preventive call, but the contract between the local company and the RDIF was finally never signed, they acknowledged from the company before the consultation by LA NACION.

A week ago, after a meeting with deputies from the ruling party, González García spoke of a figure similar to what the private laboratory was negotiating to import. "We have a vaccination plan in place, contracts signed for more than 51 million doses and open negotiations with suppliers to immunize our population." He had also anticipated it at the end of last December.

Two sources with access to the official contract without erasures assured this newspaper that HLB Pharma Group was not mentioned in the document, although it was a witness to those negotiations. That agreement, signed last December, speaks of the acquisition of 20 million doses.

Days before the Argentine laboratory formally presented its vaccine registration request to ANMAT, its commercial representatives held three meetings with different officials, according to the official records obtained by this medium. The first was with ANMAT officials, on October 9. Authorities from the National Institute of Medicines (Iname) of the regulatory agency attended. The second meeting, on October 23, was joined by officials from the Secretariat for Access to Health, led by Carla Vizzotti, who participated in two missions to Russia. The last meeting was on October 28, as it was learned through a request for access to public information (see chronology).

 

[gracielle]

Sputnik V: Cuál fue el rol de la empresa rusa que participó en la compra de las 50 millones de dosis

Se trata de una sociedad creada para vender la vacuna; también fue parte de las negociaciones un laboratorio argentino

www.lanacion.com.ar

PART 2:
27 January 2021....by Fabiola Czubaj, Iván Ruiz and Delfina Arambillet with the collaboration of Ricardo Brom.

After the first meeting with the officials, a representative from HLB Pharma accompanied in October the first Argentine delegation in Russia made up of Vizzotti, the advisers Cecilia Nicolini (Presidency of the Nation) and Raquel Méndez (Province of Buenos Aires), and Mariana de Dios, commercial director of Traditum SA, a firm dedicated to validation systems of health benefits and electronic prescriptions, among other services, for governments, prepaid or social works.

Consulted by LA NACION in this regard, the national Ministry of Health did not make any statements. From HLB Pharma, meanwhile, they indicated that they await judicial approval of the agreement with their creditors, they confirmed that they coincided with the Argentine delegation in one of three trips to Russia to agree on the commercialization of the vaccine in the country, but that the pre-agreement they had with representatives of the RDIF was not signed.

"Our plan was not to be government intermediaries," sources from the firm told LA NACION. In September, they added, the Government “changed its mind” and became interested in Sputnik V. “We feel mistreated and humiliated by Argentine officials. They treated us very badly. The government decided to run out of business. During the first trip to Russia, they used our know-how to open the negotiations, they asked us for information and then they decided that we could not sell the vaccine ”, they accused. In the Anmat, the application for registration of Sputnik V.

"Our plan was not to be government intermediaries," sources from the firm told LA NACION. In September, they added, the Government “changed its mind” and became interested in Sputnik V. “We feel mistreated and humiliated by Argentine officials. They treated us very badly. The government decided to run out of business. During the first trip to Russia, they used our know-how to open the negotiations, they asked us for information and then they decided that we could not sell the vaccine ”, they accused. In the Anmat, the application for registration of Sputnik V.

"Our plan was not to be government intermediaries," sources from the firm told LA NACION. In September, they added, the Government “changed its mind” and became interested in Sputnik V. “We feel mistreated and humiliated by Argentine officials. They treated us very badly. The government decided to push us aside from the business. During the first trip to Russia, they used our know-how to open the negotiations, they asked us for information and then they decided that we could not sell the vaccine ”, they accused. In the ANMAT, the application for registration of Sputnik V.

This presence of HLB Pharma in the negotiation generated requests for information from Congress to the Executive.

“It is not yet clear what is the role of HLB Pharma in the provision of vaccines for Argentina. The Government does not respond to different aspects that were required of this company and, on the other hand, admits that the technology transfer that will be included in the contract signed by the Ministry of Health will be in charge of "the signatory laboratories." And, as far as we know, the laboratory that signed an agreement with the Russian company is HLB Pharma ”, replied Deputy Graciela Ocaña, former Minister of Health, about the information they are analyzing in the Chamber of Deputies.

 

[gracielle]

El avión de Aerolíneas Argentinas que vuelve de Rusia también traerá 20 mil dosis de Sputnik V para Bolivia

Se suman a las 220 mil dosis que trae para Argentina.

www.clarin.com

27 January 2021
Immunization campaign: The Aerolineas Argentinas plane that returns from Russia will also bring 20 thousand doses of Sputnik V to Bolivia. They are added to the 220 thousand doses that it brings to Argentina.

The Aerolineas Argentinas plane that will arrive in the country from Russia in the next few hours will bring 20,000 doses of Sputnik V to Bolivia, in addition to the 220,000 that arrive in Argentina. Aerolineas Argentinas flight AR1063, which transports the third batch of Sputnik V vaccines from Moscow, took off this Wednesday at 18 (Argentine time) from Sheremetyevo International Airport and is scheduled to land in Ezeiza this Thursday after noon.

The AA flight comes with fewer doses than planned, since it was estimated that 600,000 doses would be transferred from Russia to Buenos Aires.

Meanwhile, the days of January are running out for Russia to complete the delivery of 5 million doses of the Sputnik V vaccine against the coronavirus that, as officially reported in the Government, Moscow promised by contract. The Russian Direct Investment Fund (RDIF) and the National Center for Epidemiology and Microbiology of Gamaleya acknowledged this Wednesday that there will be delays of up to three weeks in the delivery of the doses. As they specified through a statement, only from April there will be significant increases in production to meet the demands of the vaccine from Latin America. In the text they indicate that "they are expanding the capacity to produce more doses of Sputnik V due to the high demand for the Russian vaccine in Latin America" and that they are working on improving "the facilities located outside Russia to guarantee supply to Argentina and the rest of the region ".

The Executive admitted this week that there is a delay with the delivery of the vaccines produced by the Gamaleya Center, but they were optimistic.
"We are confident that the contract will be fulfilled and that this bottleneck in vaccine production will end when mass manufacturing begins in the coming weeks in India and Korea," Casa Rosada officials told Clarín.

The Aerolineas Argentinas Airbus 330-200 had landed in Moscow at 1:08 p.m. in Argentina, after a 16-hour flight, after taking off on Tuesday night at 9:10 p.m. from Ministro Pistarini International Airport to make the third flight that the company with a national flag carries out to Russian territory to transport vaccines.