COVID-19 vaccine development pipeline gears up

[gracielle]

Pfizer, Moderna both trying for 3rd dose booster shots to combat virus variants

Pfizer CEO echoes Netanyahu, UK authorities in saying strains of coronavirus likely to remain around indefinitely

www.timesofisrael.com

 

[gracielle]

Millones de dosis de la “vacuna latinoamericana” de AstraZeneca, demoradas por falta de envases

Los principios activos enviados a México desde la Argentina esperan en el laboratorio que se normalice la entrega de filtros, bolsas estériles y viales

www.lanacion.com.ar

25 February 2021....Enric González and Elías Camhaji....© EL PAIS, SL.
Millions of doses of AstraZeneca's “Latin American vaccine”, delayed due to lack of packaging. The active ingredients sent to Mexico from Argentina are waiting in the laboratory for the delivery of filters, sterile bags and vials to normalize.

MEXICO CITY.- Latin America has tens of millions of AstraZeneca vaccines stored in warehouses. An Argentine laboratory is manufacturing 18 million doses every month. But at the moment they cannot be used due to lack of basic supplies such as filters, sterile bags, vials or biological excipients in the Mexican laboratory in charge of finishing the product. The “Latin American vaccine” against Covid-19, produced in a Buenos Aires factory owned by Argentine businessman Hugo Sigman and financed by the foundation of the Mexican magnate Carlos Slim, has been held back by a global shortage problem. Sigman believes that we will have to keep waiting until April.

Pharmaceutical giant AstraZeneca gave up almost a year ago to make a profit from its vaccine for the duration of the pandemic and, through the Bill Gates Foundation, looked for philanthropists to bear the high costs of production. In Latin America he met Carlos Slim, one of the richest men in the world. Slim agreed on the condition that the vaccine be manufactured on the mainland. AstraZeneca decided that the active ingredient would be manufactured at mAbxience, a modern Argentine facility belonging to the Insud group, property of the husband/wife team, the physician Hugo Sigman and the biochemist, Silvia Gold. The basic product would then be sent to Mexican laboratories, Liomont, which would take care of finishing and packaging it for AstraZeneca to carry out distribution. But the plan has collided with a planetary shortage of products as basic as saline solutions, vials and syringes. Schott, the world's largest vial manufacturer, warned as early as June that it could not cope with orders for hundreds of millions of bottles. The following month, AstraZeneca CEO Pascal Soriot admitted that the problem was not "making the vaccine itself, but filling the vials," because there weren't enough on the market.

The mAbxience laboratory began manufacturing on schedule and on January 20 exported the equivalent of six million vaccines to Mexico. On February 2, it exported another six million doses. Right now mAbxience produces at a rate of 18 million doses each month and in April it will reach 25 million doses per month. This material remains paralyzed, in the Mexican laboratories of Liomont and in Argentina, waiting for the shortage of vials to be resolved. A Liomont spokesperson assured that the necessary supplies were already "guaranteed" and that the packaging would begin "soon". "The first batches will be packed next week," said Martha Delgado, Mexico's undersecretary of Multilateral Affairs. However, packaged doses will have to wait three to four weeks for regulatory authorities to verify their stability, sterility, and dosage. "These times cannot be shortened because they are biological processes," explained the official. "Once the first batches have been verified, the release of the following will be faster," he added.

To alleviate the delay, AstraZeneca offered to export part of the production of its factory in India to Argentina and Mexico. According to Hugo Sigman, 580,000 doses have already arrived from this source and another 580,000 will arrive in March. He also found another temporary solution. As the AstraZeneca vaccine is not yet authorized in the United States (the green light is expected for April), the multinational's US factory, with no shortage problems, will be in charge of carrying out Liomont's task for a few weeks. "We have already sent the equivalent of 6,400,000 doses from Argentina to the United States and next week another 6,400,000 will be released," Sigman said.

This is a frustrating situation. Liomont, whose plant is one of the largest in Latin America (1.6 million square meters), had to undertake an adaptation process at its facilities to have the necessary technology and prepare for mass production. "Liomont has excellent laboratories and has done everything that had to be done, but it has run into a planetary problem that Europe also suffers: there is a high demand for inputs and little supply," says Hugo Sigman.

There are hundreds of vaccines in development or already on the market and a race against the clock to immunize the 7.5 billion people on the planet. But the world industry does not produce more than 20,000 million vials a year, destined for ordinary pharmaceutical production. The irruption of vaccines has caused a situation close to collapse. "No one could be prepared for this, it will take months for the supply to normalize," Sigman said.

 

[gracielle]

FDA allows storage, transport of Pfizer vaccine at higher temperatures

The U.S. Food and Drug Administration on Thursday approved storage and transportation of COVID-19 vaccine developed by Pfizer Inc and German partner BioNTech SE at standard freezer temperatures for up to two weeks instead of ultra-cold conditions.

www.reuters.com

 

[FrankPintor]

Pfizer, Moderna both trying for 3rd dose booster shots to combat virus variants

Pfizer CEO echoes Netanyahu, UK authorities in saying strains of coronavirus likely to remain around indefinitely

www.timesofisrael.com

This brings up an interesting point: vaccines like the BioNTech and Moderna ones challenge the immune system with the "spike protein", which can have mutations. To protect against mutations, the vaccine needs to be modified to use a mutated spike protein. The Oxford and Gamaleya vaccines also use the spike protein, but in a different way (another innocuous virus has the spike protein).

Older vaccine technology, used now by the Sinovac and Sinopharm (bought by Argentina) vaccines use inactivated SARS-COV-2 viruses, providing the immune system with more ways to recognize the virus and potentially giving protection against mutations. The SARS-COV-2 virus does need to be inactivated, though.

I really wonder which technology is better? I think there are no clear answers at the moment.

 

[gracielle]

Vacunas. El acuerdo para la producción local no resuelve la emergencia

Vacunas. El acuerdo para la producción local no resuelve la emergencia

www.lanacion.com.ar

26 February 2021....OPINION by Nora Bär....Editor and columnist for Science and Health, La Nacion.
Vaccines. The agreement for local production does not solve the emergency.
The shortage of specific supplies and the limitations in the production of vaccines that are holding back global immunization campaigns can only make us celebrate the news of an agreement in principle between the local company Richmond Laboratories and Magement Company, of the Russian Direct Investment Fund, which would allow the production of Sputnik V in the country.

But in order not to encourage false expectations, it is important to emphasize that this initiative will not solve the emergency that we have in these weeks: hopefully and if everything goes as imagined, the first batches of the active principle would begin to be produced within about a year and a half. Elvira Zini, director of Scientific and Technical Affairs at Richmond Laboratories, explained it transparently, interviewed by Radio La Red: “We have to lower the foam a bit; we are in a very preliminary stage (…) What has just been signed is a letter of intent (…) it is a long process that has just begun (…) If we are efficient, perhaps in eighteen to twenty-four months we can have the vaccine manufactured in Argentina ; we must lower the anxiety ”.

Priority. Today, the priority is to access at least eight million more doses, of any of the authorized and available vaccines, to protect risk groups before, due to the resumption of activities, the drop in temperatures that will lead to spending more time in closed environments and the spread of new variants of the virus that are more transmissible (and, according to different studies, more lethal) the pandemic has an impact that is difficult to predict. The agreement, unfortunately, does not have immediate significance. But if confirmed, of course this venture deserves a celebration. Richmond will thus join the two plants capable of manufacturing vaccines (Biogenesis-Bagó and Mabxcience) and will provide Argentina with a capacity that in the region, outside of us, only has Brazil. The latter country has already signed a similar agreement and is manufacturing it, although it has not yet been authorized for use there.

As stated when the local manufacture of the Oxford/AstraZeneca vaccine was announced, it is not a trivial task. It requires not only having infrastructure, but also trained personnel to comply with the very high standards that regulate this activity. (Chile, which had it 20 years ago, lost it and must buy all its immunizations abroad). This allows saving huge sums in commissions, freight, taxes, fees ... And the most important thing is that it eventually grants independence to access a vital supply without depending on the decisions of external producers. In addition to being manufactured in Brazil, Sputnik is also produced in India and South Korea. Richmond Laboratories is a nationally owned company and one of the leading local providers of HIV and cancer drugs. Through subsidiaries or strategic partners, its products are marketed in 25 countries in Latin America, Africa, Asia and the Middle East.

Without wanting to spoil the party, let's not anticipate the celebration so that it does not get frustrated on the way.

 

[MilHojas]

Laboratory agrees deal to produce Sputnik V vaccine in Argentina

Russia’s Sputnik V vaccine to be produced and manufactured in Argentina by local firm Laboratorios Richmond.

www.batimes.com.ar

 

[gracielle]

Johnson & Johnson applies to WHO for COVID vaccine approval

Johnson & Johnson has applied to the World Health Organization for an emergency approval of its COVID-19 vaccines, which should help speed up its use in countries around the world.

www.wpri.com

5 facts about Johnson & Johnson’s investigational Janssen COVID-19 vaccine candidate

With its global Phase 3 clinical trial now fully enrolled with approximately 45,000 adult participants, we share the most up-to-date information about the single-dose investigational vaccine candidate.

www.jnj.com

UPDATE: 26 February 2021

Panel Recommends FDA Authorize Johnson & Johnson Vaccine For Emergency Use

The Food and Drug Administration typically follows the advice of its expert advisers. A quick agency decision on the Johnson & Johnson vaccine is expected given the state of the pandemic.

www.npr.org

 

[gracielle]

Covid: el plazo inesperado en que la Ciudad dará la segunda dosis de la vacuna Covishield a mayores de 80

Será mayor a lo que se esperaba para buscar un mejor efecto. Con una sola aplicación la eficacia llega al 76%.

www.clarin.com

26 February 2021....by Rocío Magnani
Covid: the unexpected period in which the City will give the second dose of the Covishield vaccine to people over 80. It will be greater than expected to seek a better effect. With a single application the efficiency reaches 76%.

The CABA government confirmed to Clarín that the second dose of the Oxford-AstraZeneca Covishield vaccine, with which the immunization of adults over 80 years of age and people living in nursing homes, will be administered by the City with an interval of 10 to 12 weeks from the first application, and not at 4 weeks, as had been reported in vaccinations and nationally. "All those who are now being vaccinated against Covid-19 will have to wait between 70 days and 84 days to have their second dose," said the Undersecretary of Primary Care, Gabriel Battistella, and explained that, although the last application of Covishield can be carried out after 30 days, "the studies that exist so far say that the more distance there is between each application, the more effective is the vaccine". In this way, the adult over 80 years of age who received the vaccine on February 22, when the campaign began for this population group, must wait at least until May 3 and, at most, until May 17 to receive the second dose in the City of Buenos Aires.

The term that the vaccination will take "will depend a lot on the vaccines that the City receives," Battistella clarified. "If we start with Sputnik-V in older adults, there will be a 21-day interval" between each dose and the immunization of each person will be complete in a shorter time, he clarified. "We have already applied 15 thousand doses of Covishield in older adults, with few adverse reactions," the official reported and said: "The doses are few, but we are doing well." Horacio Rodríguez Larreta's administration expects “a large quantity” of Covishield doses to arrive in the coming weeks, to complement the first batch of 40,000 units. The undersecretary denied that the decision to vaccinate after 10 weeks of the first dose is unchecked from what is established by ANMAT. "The national Ministry of Health says that you can apply the second dose of Covishield from 4 to 12 weeks and each jurisdiction establishes the rhythm based on those guidelines that you cannot differentiate from," he explained. In addition to the question of efficacy, this modality may allow "more people" to get vaccinated with the first dose before having to start the second, Battistella argued, adding that it also allows time for further advances in studies regarding the vaccine. : “Perhaps in the coming weeks a study will come out on those people who had Covid and who have significant levels of antibodies with a single dose. It is something that now we do not know, but there are already several investigations developed and perhaps even the second dose can be avoided ”.

How much does the effectiveness vary? Covishield vaccine is manufactured by the Serum Institute in India, one of the largest vaccine companies in the world, which produces it under license from Oxford-AstraZeneca. "It is a vector vaccine that uses a chimpanzee virus as a vector and has a combined efficiency of 70%, which according to the studies and the doses ranges from 60% to 90%," the infectologist and presidential advisor Eduardo López told Clarín. “It is a vaccine that the WHO and the European Medicines Agency (EMA) have approved from 18 years of age, although Germany and Spain have not approved it for people over 60 because they say that the studies for that age are not finished ” he continued. Like Sputnik-V, which has a combined efficacy (with the two doses) of 91.6%, Covishield also requires two doses - in the case of Sputnik they are different from each other, while AstraZeneca is the same formula- .

But while with the Russian vaccine, so far mainly intended for health workers, the time to apply the second dose is between 21 and 60 days after the first application, the second dose of Covishield is indicated between 28 and 84 days, the specialist detailed. Along these lines, he continued, while with AstraZeneca some countries “prefer to maintain the dose interval as it is approved in phase III of the study, which is from 28 to 30 days, the committee of experts from England proposed to extend it to 12 weeks, based on a study that says that, by spacing the interval, the vaccine could have a higher efficacy rate ”.

The study, for which the University of Oxford intervened, as well as authors from the University of São Paulo and also from South Africa, establishes that applying the second dose of Covishield at 12 weeks, "the efficacy of the vaccine studied at 14 days from that second dose rises to 82%, while when you vaccinate between 9 and 11 weeks, the efficacy is 63% ”, he explained. Regarding the first dose, "it was seen that the efficacy with a single dose of AstraZeneca vaccine from 22 days to 90 days post vaccination was 76%, and that the antibodies remained stable in this period of 90 days" added. López asked to relativize these percentages. “It must be said that the combined efficacy of 70% for the Oxford-AstraZeneca Covishield refers to a global efficacy, both for mild, moderate or severe cases of Covid-19, but the vaccine has a very high efficacy, greater than 90% for the most serious forms of Covid-19. It is not the same as an older adult acquiring a cold or flu from Covid-19 than having to be hospitalized, ”he said.

Argentine physician Marta Cohen, who lives in the UK and from there has closely followed the progress with the AstraZeneca vaccine, also supported the decision to apply the vaccine after week 10. “In Brazil and South Africa, while the study was done, the second dose had not arrived due to production issues. So some were given it at 4 weeks, others at 6, others at 12. The researchers were transparent, explained this and analyzed the results and saw that immunity is higher between week 8 and 12 ”, explains Cohen. For her, it is also a good measure to use the available doses to vaccinate more people with a single application. “If there are 10 million doses, vaccinate 10 million people and not five. That was the criterion that was applied in the UK, where daily infections fell from 68,000 to 8,000 per day ”, she remarked.

 

[gracielle]

Pfizer and AstraZeneca vaccines found to reduce Scotland hospital admissions by 85% and 94%

The Pfizer and AstraZeneca Covid vaccines have both been found to have an impact in the reduction of a person’s risk of hospital admission from coronavirus, according to new research.

www.edinburghnews.scotsman.com

 

[gracielle]

Single dose of Pfizer vaccine may reduce transmission, early U.K. study suggests - National | Globalnews.ca

The study and its results have yet to be independently peer-reviewed by other scientists, but could bring the world closer to understanding how vaccines impact transmission.

globalnews.ca