COVID-19 vaccine development pipeline gears up

Status
Not open for further replies.
El ministro de Salud de la Nación, Ginés González García, supervisó hoy en el Hospital Posadas la aplicación de la segunda dosis de la vacuna Sputnik V contra la COVID-19 en el personal de salud que recibió la primera hace 21 días, plazo mínimo que debe haber entre dosis.
“We are accessing the vaccines according to the contracts we have signed. We have more than 51 million doses insured with a national vaccination program throughout the country for when the campaign goes to scale. ” Ginés González García
 
Last edited:
20 January 2021
Government intends to start vaccination against COVID-19 at the end of February
Initial doses of the vaccine against the new coronavirus would be enough for a "wide vaccination" throughout the health system.

The Pfizer-BioNTech vaccine will be the first to arrive in Uruguay. The government of Luis Lacalle Pou intends to start vaccinating at the end of February. The doses will arrive at the Carrasco International Airport from Europe, since the agreement with the BioNtech laboratory and the Uruguayan State establishes that the doses leave from Belgium, according to El País reported on Friday, January 15, based on official sources.

Pfizer-BioNTech will be the first to arrive in Uruguay but not the only one. At least three other vaccines from three laboratories are in "more than advanced" negotiations
....The great progress in the negotiations that made it possible to seal contracts with laboratories producing the vaccines, motivated the Executive Power to draft a decree that empowered the Secretary of the Presidency, Álvaro Delgado, and the Minister of Public Health, Daniel Salinas, to sign contracts for the purchase of vaccines on an "urgent" basis....

....The Russian "Sputnik V" and the Chinese "Sinovac" are part of the immunization "package" that the government negotiates for the Uruguayan population. The health authorities have another option to add doses to the country in addition to the three mentioned in this newspaper article.
 
 
The Cavalry is near.......
The technical report analyzed by the Government affirms that Sputnik V is very effective in those over 60 years of age and the ANMAT will support its application

The dossier sent by Moscow was translated and analyzed in record time, while the Health Ministry prepared an administrative resolution authorizing the use of the Russian vaccine in the main risk group in Argentina
 
20 January 2021
CABA: what will the operation be like to vaccinate people over 70 years old.

Health Minister Fernán Quirós assured that "everyone will have a nearby place to get vaccinated" and that all nursing homes have already been informed that the Sputnik V vaccines will be available for this population by the end of the month. The Minister of Health Fernán Quirós anticipated that once the first stage of vaccination against the coronavirus, intended for health workers, has been completed, the campaign for those over 70 years old will begin.

“We are going to open the registration for vaccination as the national government confirms the date and number of vaccines. We do not want to pre-register citizens who still do not know when the vaccination will correspond ”, he assured at a press conference. He also assured that "everyone will have a nearby place to get vaccinated" and that all nursing homes have already been informed that the Sputnik V vaccines will be available for that population by the end of the month. “We have set up a vaccination device that can go to nursing homes. We are going to deploy a strategy of territorial mechanisms to serve those over 70 years of age, ”said the minister.


Coronavirus in the CABA....
 
The Cavalry is near.......
The technical report analyzed by the Government affirms that Sputnik V is very effective in those over 60 years of age and the ANMAT will support its application

The dossier sent by Moscow was translated and analyzed in record time, while the Health Ministry prepared an administrative resolution authorizing the use of the Russian vaccine in the main risk group in Argentina

Can't even think the pressure the ANMAT must have been under to determine it's safe for over 60..! Could the ANMAT have determined otherwise ?
 
20 January 2021
The agency's reasons for approving the Russian vaccine....
What the ANMAT report says about the application of Sputnik V in people over 60.
As the Ministry of Health had advanced, the National Administration of Medicines, Food and Medical Technology (ANMAT) finally approved the use of Sputnik V in people over 60 years of age, after registering "an efficacy range of 91, 8% "for the age group in question. "Safety, immunogenicity and efficacy are within an acceptable margin," the agency emphasized in the document issued this Wednesday....
 
19 January 2021
What conditions must be met by those over 60 to be immunized. Coronavirus: the keys to the second stage of vaccination.
According to the Ministry of Health, the universe of people over 60 who can access voluntarily and free of charge is 7,375,000 people throughout the country. Among the main questions arise whether those who already had covid-19 should be vaccinated and what are the possible symptoms after vaccination....The universe of people over 60 years of age who can access voluntarily and free of charge -with the simple presentation of the DNI and without a medical order....Among them, the first priority step will be adults over 70 years of age (age group in which the fatality rate in Argentina increases from 2.7 to 18.3 percent and reaches 39.1% in those over 80 years of age).

....Should Older Adults Recovered From Covid-19 Get Vaccinated?
The Ministry of Health indicated that "all persons belonging to the target population will be able to access vaccination, regardless of having previously had the disease." In the portal of the Buenos Aires Ministry of Health, which launched the "Vacunate" pre-registration campaign, the specific case of those infected with Covid-19 who received plasma treatment is specified. "There are currently no data on the safety or efficacy of Covid-19 vaccination in people who have received monoclonal antibodies or convalescent plasma as part of treatment for Covid-19. Therefore, for the moment the recommendation is that vaccination be postponed for at least 90 days after treatment to avoid its interference in the immune response induced by the vaccine ", recommends the Health portfolio headed by Daniel Gollán.

Contraindications

Another point to attend to before approaching the vaccination points is to know if there are contraindications that prevent a person from receiving the vaccine. The Ministry of Health, based on the information available from the safety and efficacy studies, lists the following contraindications for the application of the first dose of Sputnik-V:
*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, which involve compromise of the general state.


Should preventive measures be maintained after the application of the vaccine?
The Ministry of Health emphasizes that, once the first dose has been applied, people should be alert to the appearance of some possible symptoms due to the application of the vaccine, which may be local (pain, swelling and increased temperature at the site of the injection) or general (chills, fever, arthralgia, myalgia, asthenia, malaise, headache). If you have any questions, you can call line 120.

Once that period has passed, vaccinated people cannot be considered immunized, that is, with the necessary antibodies to avoid getting Covid-19. "It is too early to know how long the protection conferred by the vaccine will last, and whether or not it will be long-term," warns the Ministry of Health and indicates among some of the factors the age of the vaccinated person, something relevant within the population risk of more than 60 years, to which are added underlying diseases, immune status and virus variability.

In any case, based on the studies carried out in recovered people, the health portfolio highlights that "most people who recover from COVID-19 develop an immune response that offers at least some protection against a new infection, although The intensity and duration of that protection has not yet been determined. "

On the other hand, the Ministry of Health warns that "the different vaccines against Covid-19 will not be interchangeable", therefore, the population that begins to be vaccinated with Sputnik-V must comply with the plan with the same vaccine for second dose. This is imperative in the case of the Gamaleya Institute vaccine, since the two doses have different components.

Finally, the care recommendations highlight that vaccinated people should continue to respect preventive measures - mask, hand washing, social distance - until scientific studies advance and prove the level of immunization of the vaccines and their duration.
 
20 January 2021
....India authorised two vaccines this month for emergency use at home, one licensed from Oxford University and AstraZeneca and another developed at home by Bharat Biotech in partnership with the state-run Indian Council of Medical Research. Both are manufactured locally.

However, Bharat Biotech on Tuesday warned people with weak immunity and other medical conditions including allergies, fever or a bleeding disorder to consult a doctor before getting the shot – and if possible avoid the vaccine. The company said those receiving vaccinations should disclose their medical condition, medicines they are taking and any history of allergies. It said severe allergic reactions among vaccine recipients may include difficulty breathing, swelling of the face and throat, rapid heartbeat, body rashes, dizziness and weakness.

The Bharat Biotech vaccine, called Covaxin, ran into controversy after the Indian government allowed its use without concrete data showing its effectiveness in preventing COVID-19. At least two other vaccines are expected to be authorised by India in the next few months.

India will initially ship only the AstraZeneca vaccine, made by the Serum Institute of India, the world’s biggest vaccine maker, which brands the shot as Covishield.
 
21 January 2021....By: Nora Bär, Scientific journalist and Editor of Science/Health for La Nacion.
Sputnik: the opinion of experts on the recommendation of the ANMAT to vaccinate those over 60 years.
Almost at the same time that the Russian Direct Investment Fund requested emergency approval for its Sputnik V vaccine before the European regulatory authority (EMA), yesterday at noon Anmat released a statement in which it reported that, "after analyzing the new information provided , it was established that it is within an acceptable margin of safety, immunogenicity and efficacy for the age group over 60 years "and recommends its use to the Ministry of Health of the Nation....

....As detailed by ANMAT, in its initial analysis of December last year it had already highlighted that the efficacy, immunogenicity and safety data for the total study population, between 18 and 87 years of age, reported an acceptable profile and that it had not recorded unexpected adverse events up to that point. But considering the number of subjects over 60 who should receive this vaccine, a new safety analysis was suggested to verify if, in a greater number of individuals, others emerged.

The manufacturer presented new documentation specifically on its effects in older persons who reported a "91.8% efficacy range"; "antibody formation in 98.1% on day 28 after vaccination" and a safety profile "that does not differ from that observed in the rest of the population".

Regarding the efficacy of the vaccine in this age group, the specialist, Ángela Gentile, Head of Epidemiology at the Ricardo Gutiérrez Children's Hospital and member of the National Commission for Vaccine Safety (Conaseva) explains that it is known that, as age increases, the immune response is lower. "The final result of phase 3, in this and in all vaccines, we will have by the middle of the year. Based on the data available, with two doses the efficacy seems very good - she emphasizes -. Surely when the studies are finished we will to have more adjusted data. If they exceed 90%, they are very good; remember that in the middle of last year the FDA had said that 50% or more efficiency was enough in a pandemic. "

"The additional information from Gamaleya indicates that with a universe of 2,144 over 60 years of age they had an efficacy of 91.8%; that is, analogous to the results presented by volunteers in general in the interim analysis presented on November 23, which indicated 91.4% "stresses the virologist from INTA, Humberto Debat." This is excellent news, because in general some reduction in efficacy is expected since the functioning of the immune system may decline with age. They do not indicate on the basis of what number of events was verified that efficacy, but the confidence interval and p-value (the probability that the results of a clinical trial are given by chance) look good. "

"In the additional reports sent by the Gamaleya Institute, the efficacy was very high, not only to prevent the disease, but also its serious forms," says the renowned vaccine expert Eduardo López, infectologist at the Ricardo Gutiérrez Children's Hospital. This is one of the most important benefits of all vaccines. The Oxford/AstraZeneca vaccine has a combined 70% efficacy in preventing contagion, but is greater in reducing severe forms. " According to the specialist, another important point of this immunization, unlike those developed with newer technologies, is that it had practically no adverse effects or caused serious allergies. The formation of specific antibodies against the coronavirus was registered in 98.1% of the volunteers on day 28 after vaccination.

For this reason, López emphasizes that it would be important that the doses be given in the sequence analyzed during the trial. "I would try to give them as close as possible to 21 days," he says, "as was studied. Especially considering that the national immunization strategy, as occurs in other countries, is to target older adults, who are more than seven million people "....

In addition to Russia, Argentina, Paraguay, Bolivia, Venezuela, Algeria and Serbia have already approved the Sputnik V vaccine, among others. As the clinical trial in those over 60 demonstrated an efficacy of more than 90%, this age group is now included in the vaccination guidelines of all countries.
 
Status
Not open for further replies.
Back
Top