COVID-19 vaccine development pipeline gears up

[gracielle]

Los Ni-Ni de la pandemia: 15 millones de argentinos ni esenciales ni de riesgo quedarían sin vacunarse contra el Covid

Tienen entre 18 y 60 años, y ninguna enfermedad de base. Los expertos admiten que muy probablemente para ellos no habrá vacunas al menos este año. Fondo COVAX: cuáles son y cuándo llegarán los otros 9 millones de vacunas que anunció el Gobierno

www.clarin.com

Published on 23 January 2021....behind a paywall.
The Ni-Ni of the pandemic: 15 million Argentines neither essential nor at risk would remain without being vaccinated against Covid. They are between 18 and 60 years old, and have no underlying disease. Experts admit that there will most likely be no vaccines for them at least this year.
The national government promised to vaccinate against the coronavirus, during this year, more than 25 million people over 18 years of age with 51,431,000 million doses that will be supplied twice.

The Ministry of Health has insured 22.4 million doses from the AstraZeneca company; 20 million from the Russian Sputnik V vaccine; and 9 million from the Covax plan. It is also in negotiations with the firms Pfizer, Jannssen, Sinovac, Sinopharm, Moderna and CanSino. The information comes from a document that was distributed in the last hours to the members of the Health Commission of the Chamber of Deputies. The text indicates that the more than 50 million doses will be distributed in an order of priority. Some 821,394 doses will be destined for health workers; 7,414,866 for people aged 60 or over (167,936 in the 5,173 residences for the elderly); 493,727 for members of the armed and security forces; 4,063,968 for patients between 18 and 59 years old with comorbidities. In addition, the plan includes 1,417,310 members of the education personnel (primary, secondary and tertiary) and 266,034 for essential personnel of the State, such as university teachers and others.

So who won't get it? The official site Argentina.gob.ar proposes contraindications for the application to those under 18 years of age (due to the lack of data on efficacy and safety in this age group) and to pregnant or lactating women (because it has not been studied its efficacy and safety during this period). It is also not indicated for people with hypersensitivity to any component of a vaccine or to a vaccine that contains similar components; history of severe allergic reactions; serious acute diseases (infectious and non-infectious) or exacerbation of chronic diseases that involve compromise of the general state.

Then there are what we could call “Ni-Ni”. We are talking about people who are not essential (not doctors, teachers, or police) and who do not belong to any risk group. They are between 18 and 60 years old, and have no underlying disease. It is estimated that there are about 15 million Argentines. The technical guidelines for the National Vaccination Campaign against Covid-19 - released in December by the Ministry of Health - puts them in seventh place in the order of priorities. And it describes them as: "Other strategic populations defined by jurisdictions and dose availability." They too are supposed to be - some day - immunized. Because, as reported in this campaign, it seeks to "vaccinate 100% of the target population in a staggered and progressive manner, in accordance with the gradual and increasing availability of the resource and the prioritization of risk."

Consulted by Clarín, the pediatrician and epidemiologist Norberto Giglio says he is "optimistic" that this group will have access to vaccines, although he assumes that "we do not know the amount of vaccines we will have throughout 2021." "As we know, staggered goals are being pursued. In the short term, it is keeping essential personnel active to help people in need. In the long term, achieving herd immunity," he says. According to Giglio, no one knows exactly what is the "magic" number that guarantees herd immunity, either by recovered patients with long-lasting immunity or by vaccinated people. And he says that some experts, such as Dr. Anthony Fauci, have warned that control of the disease may require immunity rates of between 70 and 90% of the population.

The problem is when this seventh group will receive the vaccine. Or, at least, when will 70% of that target population do so, which could serve to achieve herd immunity? “It is virtually impossible to arrive in terms that are less than one year. I really see it very difficult, "said the former Minister of National Health, Adolfo Rubinstein, in an interview with Clarín. Meanwhile, the expectation grows. A survey that covered 47 countries - and that in Argentina was carried out by Voices! - concluded that our country is above the global average, with 79% of people saying that they would receive the vaccine if it were considered safe and effective. Among those willing to apply it, there is a higher proportion of men (85% vs 73% women) and young people between 18 and 29 years old (87%). But this last group is, precisely, among the least prioritized to obtain it.

For those who have the intrigue, a calculator created on the Omni Calculator platform allows estimating, according to the profile of each person, when they would get the jab in Argentina.

 

[gracielle]

Entusiasmado con la campaña de vacunación, el ministro González García no piensa en renunciar

A pesar de las internas políticas y sucesivas desautorizaciones, Ginés no se inmutó y sigue adelante. La semana próxima viaja con el Presidente a Chile, donde fue embajador

www.infobae.com

24 January 2021....Opinion by Silvia Mercado.
Excited about the vaccination campaign, Minister González García does not think of resigning. Despite the internal policies and successive disavowals, Ginés was unmoved and continues to move forward. The next week he travels with the President to Chile, where he used to be the ambassador....
....The Argentine Government has a National Vaccination Plan against the pandemic that is validated by independent experts, international organizations, responsible for all the jurisdictions of the country, from all ministries, officials, trainers and volunteers committed and perfectly consolidated with this challenge that does not have precedents in the history of the country. But instead of going out to communicate it with pride and passion, it is debated in countless internal policies and so opposed diagnoses about how to get the country out of the abyss. What comes to attention is the still relative tolerance of the population.

 

[lunar]

Cristina Kirchner recibió la primera dosis de la vacuna rusa contra el coronavirus

La vicepresidenta se vacunó en el Hospital Presidente Perón de Avellaneda. Se la aplicó el viceministro de Salud bonaerense, Nicolás Kreplak.

www.clarin.com

Cristina got vaccinated by Sputnik V.

 

[gracielle]

A la espera de los vuelos de las vacunas | Mañana confirmarían el cronograma

El vuelo a Rusia para retirar las vacunas comprometidas por contrato no saldrá este domingo y el cronograma recién se va a confirmar el lunes. Las autoridades del Ministerio de Salud y las de Aerolíneas Argentinas están esperando el visto bueno de Mosc...

www.pagina12.com.ar

25 January 2021
Tomorrow they would confirm the schedule. Waiting for vaccine flights.
The flight to Russia to withdraw the vaccines committed by contract will not leave this Sunday and the schedule will only be confirmed on Monday. The authorities of the Ministry of Health and those of Aerolineas Argentinas are waiting for the approval of Moscow, which, as Pagina/12 anticipated, has already reported that the vaccines will be available as stated in the contract: four million from dose 1 and one million from dose 1, dose 2 before the end of the month. The Direct Investment Fund of Russia (RDIF), which handles Gamaleya's vaccines, promised on Monday to confirm the final schedule and with this the flight program will be made....
....Aerolineas Argentinas is waiting for the definitive schedule because several flights are needed to fetch five million vaccines. Moreover, it was also necessary to get the approval of the unions because it will involve numerous trips, outside the usual routes. The head of the Pilots Association, Pablo Biró, has already signed the authorization and the company is awaiting the schedule that comes from Russia. In Moscow they say they will confirm everything this Monday.

 

[gracielle]

Mexican president's COVID-19 revelation fuels criticism of pandemic response

The Mexican president's announcement he had COVID-19 just a few hours after taking a commercial flight unleashed renewed criticism of his handling of the pandemic, which has left the country with the fourth-highest death toll worldwide.

www.reuters.com

Russia to supply Mexico with 24 million COVID-19 vaccines, president says

Russia will supply Mexico with 24 million doses of the Sputnik V COVID-19 vaccine over the next two months, Mexican President Andres Manuel Lopez Obrador said after a phone call on Monday with Russian counterpart Vladimir Putin.

www.reuters.com

 

[gracielle]

Covid: France, Germany and Austria say goodbye to cloth masks

Stop to cloth masks. At least in closed places and where social distancing is less manageable. France, Germany and Austria are deciding it, but also in Italy there are the “strong recommendat…

www.italy24news.com

 

[artisans]

The flight to Moscow was postponed to bring a new shipment of the Russian vaccine against the coronavirus
It will not come out this Monday as planned. Official sources confirmed that no confirmation came from Russia. For now there is no new date

Otra vez se postergó el vuelo a Moscú para traer un nuevo cargamento de la vacuna rusa contra el coronavirus

No saldrá este lunes como estaba previsto. Fuentes oficiales confirmaron que no llegó la confirmación desde Rusia. Por ahora no hay una nueva fecha

www.infobae.com

As Gracielle noted earlier, logistics. It appears Russia isn't ready to ship yet, the Aerolineas Argentina planes have a capacity of 400,000 which may be expanded to 600,000. And so on. We're now in the meat grinder of production and delivery and distribution. Like waiting for Santa on Christmas eve.

 

[gracielle]

Germany to use new antibody-based coronavirus drug – DW – 01/24/2021

Health Minister Jens Spahn has said the government has purchased a new drug to help fight COVID-19 amid a vaccine shortage. Germany will be the first EU nation to use the medicine, which was also given to Donald Trump.

www.dw.com

 

[gracielle]

Johnson & Johnson COVID-19 Vaccine: What You Need to Know

Learn how the Johnson & Johnson COVID-19 vaccine works, how safe and effective it is, and who can get it when.

www.verywellhealth.com

Data show COVID-19 vaccine from Johnson & Johnson spurs immune response - UPI.com

A one-shot COVID-19 vaccine developed by Johnson & Johnson is safe and generates an immune response to block the novel coronavirus that causes the disease, according to results of an early-stage clinical trial.

www.upi.com

UPDATE: 21 January 2021

Potential 'game-changer': Hopes high for Johnson & Johnson COVID vaccine if authorized

Results are expected soon for Johnson & Johnson's experimental COVID vaccine. Its single dose and simple storage make it much easier to use.

www.usatoday.com

 

[gracielle]

PART 1:

Vacuna Sputnik V: tachaduras, el borrador ruso y otras sorpresas en un expediente guardado bajo siete llaves

Vacuna Sputnik V: tachaduras, el borrador ruso y otras sorpresas en un expediente guardado bajo siete llaves

www.lanacion.com.ar

26 January 2021....by Fabiola Czubaj and Pablo Fernández Blanco.
Sputnik V vaccine: erasures, the Russian draft and other surprises in a file kept under seven keys.
Surrounded by workers in a climate that is familiar to him, in the heat of the end of the year and with the good news of being applying the first doses of the coronavirus vaccine in the country, Ginés González García was sincere. "The President [Alberto Fernández] is nervous because the papers are not arriving," he said in a corridor of the Posadas Hospital. He was referring to information from clinical trials on Sputnik V needed for use in people over 60, something that was finally approved last week.

The "papers", as the Minister of Health said, were both a problem and a priority for the Argentine government in its race to secure a vaccine in the midst of a pandemic. To such an extent that they led to controversial situations and questioned decisions. LA NACION reviewed at least 10 unknown documents so far and corroborated the existence of other papers that are handled with the confidentiality of matters that affect national security.

The specific file with the information on the purchase of the vaccine is confidential. As LA NACION was able to verify, between December 3 and 12, only seven officials had had access, including Minister Ginés González García and the Secretary for Access to Health....LA NACION's investigation revealed several oddities. Among them, that the first official document for the approval of the Russian vaccine was based on a press release and not on a scientific report. In addition, the procedures were carried out in record time for the public administration, with intervals of a few hours and with little advance of the arrival of the first flight with the vaccine from Russia. At that time, highly complex issues were signed and only seven officials have access to the most sensitive papers, an exception in the handling of government procurement procedures.

The documents reviewed show the existence of contracts with many non-visible pages - some of them even suggest that the Argentine government itself did not find out all the details from Russia - phrases that cast doubt on information from that country and the accelerated progress of local processing without waiting for Argentine officials to arrive from Moscow. On December 23, while images arrived of how the first vaccines were loaded in the so-called Operation Moscow, at least five documents were approved and exchanged between the Ministry of Health and the ANMAT, including the opinion of the Directorate of Legal Affairs. Credit: Presidency.

On December 18, some of the statements from the members of the official delegation that returned on the Aerolineas Argentinas flight with the first shipment of 300,000 doses arrived from Russia. Around the same time, the national director of Communicable Disease Control, Juan Manuel Castelli, signed a technical report on the efficacy of the vaccine. It was based on information for the press and negotiations were still ongoing.
"On December 14, 2020, the press report made by the Gamaleya National Research Center for Epidemiology and Microbiology was received in conjunction with the Ministry of Health of the Federation and the Direct Investment Fund of Russia," the document begins. Six paragraphs later, he looks at a piece of information about the first known results of the trial: "It claims to have been carried out on 22,714 volunteers," he says.

Confidential: State procedures related to the purchase of Sputnik V are secret, despite the fact that a regulation of the Ministry of Health requires greater publicity. This report is used as scientific validation of another document in the file. It is a presentation by Khabriev Ramil Usmanovich, member of the Russian Academy of Science, on December 17, one day before the text signed by Castelli. That work was attached to the file in a PowerPoint file. "If the approval is made by an agency that prequalifies for Argentina, such as the US FDA, or those of the UN, it can advance in a more expeditious way. But when the active principle has not yet been approved by agencies that prequalify, there has to be a different procedure, with more detailed documentation, "explains former Health Minister Adolfo Rubinstein, who despite criticism does not believe that the Russian vaccine is less effective than the others. "The only data available so far is Gamaleya's press report. The Pfizer, Moderna and AstraZeneca vaccines were published in scientific journals, they had peer criticism, and there is more information. This is the congenital weakness of the Sputnik vaccine".

Five days after the first report, the acceleration of the state bureaucracy to pass Sputnik V reached a record for the public administration. On December 23, while images arrived of how the first vaccines were loaded on the plane of the so-called Operation Moscow, at least five documents were approved and exchanged between the Ministry of Health and the ANMAT, including the opinion of the Directorate of Legal Affairs of the González García portfolio in favor of the approval of the product. The process did not take more than an hour and a half. Everything happened between 11.11pm and 12.46am on the day before Christmas Eve. See Copy of Official communique....On December 18, the members of the official delegation made statements in Russia. Around the same time, the national director of Communicable Disease Control, Juan Manuel Castelli, signed a technical report on the efficacy of the vaccine. The documents are a preliminary technical report from ANMAT on the results of the vaccine according to Gamaleya; a report from the National Institute of Medicines (Iname) that replicates the information in the preliminary report; a report from the Directorate of Evaluation and Registration of Medicines, also from ANMAT, a technical report on the regulatory profile and, finally, the legal opinion that gives the go-ahead to the Government for the approval of Sputnik V.

The first of the documents already explains that, until the arrival of the vaccine in the country, those over 60 exposed to the product under investigation had been only 1029 and it was recommended to wait for more information. The second document throws up another peculiarity. The Directorate for the Evaluation and Registration of Medicines is based on the analysis of a draft sent by Russia on an intermediate study of the product that is even subject to review by the Ministry of Health of that country. Documentation of good production practices with certifications from Russian authorities is also incorporated. There are no European or other country validations. The documentation that LA NACION reviewed shows another novelty. A Risk Management Plan (PGR) is in force, something that until now no one reported. This "will allow the monitoring of the safety and efficacy of the product, with special attention to the possible pharmacovigilance reports that could be presented on adverse effects." Its details are not public either.

The bureaucratic race on the 23rd, hours after the flight with the first doses landed in Ezeiza, ends with the signing by Claudia Beatriz Rivero, general director of Legal Affairs of the Ministry of Health. The lawyer recalls that the agreement in that portfolio and the company in charge of selling the vaccine, Limited Liability Company Human Vaccine, is reserved. On Wednesday, January 20, an extension of the technical report of the Limeres regulatory profile that recommends the use of the vaccine in people over 60 says: "From the synopsis of the report of the study of safety, tolerability and immunogenicity in people over 60 years it was reported that, of the total of the volunteers included in this study, 97% had some type of comorbidity at the time of selection, mainly arterial hypertension, diabetes and/or dyslipidemia ". And the text continues: "Of the 109 subjects exposed to the two components of the vaccine (age range 60 to 85 years), a single serious adverse event not related to the vaccine was observed."....

See Part 2 on page 57 of this thread....