Covid-19: Razvoj vakcine, imunitet i primena medikamenata

[vememah]

 

 

Zvanično saopštenje Fajzera i Bionteka:

 

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New York, NY and Mainz, Germany, February 17, 2021 (GLOBE NEWSWIRE) — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced results from an in vitro study that provides additional data on the capability of sera from individuals immunized with the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to neutralize SARS-CoV-2 with the South African variant spike protein. This study, which builds on previous work, was conducted by Pfizer and the University of Texas Medical Branch (UTMB), and results were published in the New England Journal of Medicine.

The current in vitro study investigated the full set of South African variant (also known as B.1.351 lineage) spike mutations. To this aim, three genetically engineered recombinant viruses were produced. One virus had the full set of spike glycoprotein mutations found in the South African variant and the other two had subsets of these mutations. The viruses were tested against a panel of sera from 15 participants in the previously reported Phase 3 trial who had been immunized with the Pfizer-BioNTech COVID-19 vaccine.

Although the results indicated a reduction in neutralization of virus with all the South African variant spike glycoprotein mutations, all the sera neutralized all the viruses tested. This finding is consistent with recent reports of the neutralization of variant SARS-CoV-2 or corresponding pseudoviruses by convalescent or post-immunization sera.^i,ii

There is no clinical evidence to date that the South African variant virus escapes BNT162b2-elicited protection from COVID-19 in vaccinated people. Nevertheless, Pfizer and BioNTech are taking the necessary steps, making the right investments, and engaging in the appropriate conversations with regulators to be in a position to develop and seek authorization for an updated mRNA vaccine or booster once a strain that significantly reduces the protection from the vaccine is identified.

Pfizer and BioNTech are currently evaluating neutralization of SARS-CoV-2 with the Brazilian strain spike mutations, as well as mutations from other emerging SARS-CoV-2 variants, and they continue to conduct studies to monitor the vaccine’s real-world effectiveness. Pfizer and BioNTech believe that the flexibility of BioNTech’s proprietary mRNA vaccine platform is well suited to develop new vaccine variants if required.

https://investors.biontech.de/news-releases/news-release-details/vitro-study-published-new-england-journal-medicine-demonstrates

Edited February 18, 2021 by vememah

[djeneralche]

Mozda je vec neko objasnio, zasto ljudi mere antitela kod mRNA vakcina ako su to samo informacije za neki buduci slucaj infekcijom korona virusom? Antitela bi trebalo da se proizvedu samo ako virus udje u organizam.

[Dankan Ajdaho]

Ovo sa Sputnjikom i EMA je isključivo politička igranka i ništa drugo. Poenta je da EU NE ŽELI rusku vakcinu i tu se čitava priča završava. Učiniće sve što je u njihovoj moći da otegnu proces što je više moguće ili da ga učine nemogućim za dobijanje dozvole.

 

Stoga će ko želi bilateralno odraditi posao kao Orban i ćao zdavo doviđenja.

[Spooky]

2 hours ago, djeneralche said:

Mozda je vec neko objasnio, zasto ljudi mere antitela kod mRNA vakcina ako su to samo informacije za neki buduci slucaj infekcijom korona virusom? Antitela bi trebalo da se proizvedu samo ako virus udje u organizam.

Zato sto mRNA radi tako sto u nasim celijama proizvodi taj Spajk protein virusa, pa nase telo pokrece imuni odgovor, izmedju ostalog praveci i antitela na spajk protein... Eto, izmeris antitela na smajk protein (ne obicna antitela koja mogu biti na bilo koji protein virusa, npr. na omotac)...

[borris_]

CNN objavio ugovor Astra Zeneca / UK koji potpisan dan poslije potpisa sa UE i sadrzi iste tacke u vezi isporuke (best effort). Rezultat, za EU su smanjili broj vakcina koje su trebali da isporuce, za UK nisu.

 

AstraZeneca's vaccine contract with the UK is based on 'best efforts,' just like its deal with a frustrated EU - CNN

 

 

[vememah]

 

Ceo intervju:

 

 

Edited February 19, 2021 by vememah

[vememah]

 

 

 

 

 

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00448-7/fulltext

Edited February 19, 2021 by vememah

[vememah]

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SOUTH AFRICA

Pfizer plans to test Covid-19 vaccine booster targeting the variant identified in SA

19 February 2021 - 08:34 BY MICHAEL ERMAN

A top Pfizer Inc scientist says the company is in intensive discussions with regulators to test a booster shot version of its coronavirus vaccine specifically targeted for a highly contagious variant that is spreading widely in SA and elsewhere.

A laboratory study released on Wednesday suggested that the “South African” virus variant may reduce protective antibodies elicited by the Pfizer/BioNTech vaccine by two-thirds, but it is not clear how much that reduces the shot's effectiveness against this version of the pathogen.

Phil Dormitzer, one of Pfizer's top viral vaccine scientists and a co-author of the study, said in an interview he believes the current vaccine is highly likely to still protect against the concerning variant first discovered in SA.

“A level of neutralising antibodies that may be on the order of between a third and a half the level of neutralising antibodies you see against the original virus does not mean you have only a third to half of the protection level, you may well have full protection,” he said.

University of Texas Medical Branch professor and study co-author Pei-Yong Shi said he also believes the lessened immune response observed is likely to be significantly above where it needs to be to provide protection.

Shi said that in clinical trials, both the Pfizer/BioNTech vaccine and a similar shot from Moderna Inc conferred some protection after the first of two doses with an antibody response lower than the reduced levels seen in the laboratory study of the South African variant.

Still, Dormitzer, chief scientific officer of viral vaccines at Pfizer Vaccines Research and Development, said the company was developing plans to test a redesigned booster for the vaccine.

“We're not doing that primarily because we think that means that we're going to need to change that vaccine,” he said. “It's primarily to learn how to change strain, both in terms of what we do at the manufacturing level, and especially what the clinical results are.

“So if a variant comes along for which there is clinical evidence of escape, we're ready to respond very quickly,” Dormitzer added.

He said the company has already made a DNA template for a prototype vaccine targeting the variant and plans to manufacture a batch of it.

The company is proposing to do a Phase I clinical trial of a booster shot of that prototype vaccine that it would test against a booster for the current vaccine.

“This will be a immunogenicity study, where you look at the immune response. And those studies are much, much smaller than the giant efficacy studies,” Dormitzer said.

“In immunogenicity studies you can look at the immune response of every person in the study. It's not as definitive as efficacy data, for sure. But it can be gathered much more quickly,” he explained.

The company would likely conduct some animal testing in parallel as well, he said.

The US Food and Drug Administration has not yet released a road map for how companies should design trials of coronavirus booster shots.

https://www.timeslive.co.za/news/south-africa/2021-02-19-pfizer-plans-to-test-covid-19-vaccine-booster-targeting-the-variant-identified-in-sa/

Edited February 19, 2021 by vememah

[vememah]

Konačno nešto pozitivno o oksfordskoj vakcini:

 

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AstraZeneca and Oxford University’s COVID-19 vaccine is more effective when its second dose is given three months after the first, instead of six weeks, a peer-reviewed study published in The Lancet medical journal showed on Friday.

The study confirmed the Anglo-Swedish drugmaker’s findings from earlier this month that showed the vaccine had 76% efficacy against symptomatic coronavirus infection for three months after the first dose.

Efficacy was found to be at 81% with the longer interval of 12 weeks between the first and second dose, compared with 55% efficacy up to the six-week gap, according to the Lancet study, which backs British and WHO recommendations for longer intervals. (bit.ly/3bmLX25)

Faced with a resurgence in infections and new, highly transmissible variants of the virus, many countries are hoping to broaden immunization by giving some protection to as many people as possible with a first dose, while delaying subsequent shots.

https://www.reuters.com/article/us-health-coronavirus-astrazeneca/astrazeneca-oxford-vaccine-more-effective-with-longer-dose-gap-study-idUSKBN2AJ1WZ?rpc=401&

 

https://www.thelancet.com/action/showPdf?pii=S0140-6736(21)00432-3

Edited February 19, 2021 by vememah

[vememah]

 

[vememah]

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Pfizer and BioNTech submitted new data to the FDA that shows the stability of the vaccine at -25°C to -15°C (-13°F to 5°F). These are temperatures usually found in pharmaceutical freezers and refrigerators. The companies have proposed an update to the EUA prescribing information, which would allow the institutions involved in COVID-19 vaccination campaigns to make changes to their vaccine distribution protocols and expand the vaccine’s reach.

The two companies explained that the new FDA submission includes stability data generated on vaccine batches manufactured in the past nine months, including batches that were used for clinical trials. Pfizer and BioNTech will also issue the same documentation to other regulators around the world that have authorized the drug for emergency use. Since mid-December, the vaccine has been used in various markets, including the US, UK, Europe, Israel, and more.

The current EUA labels say that the vaccine must be stored in ultra-cord freezers at temperatures ranging from -80ºC to -60ºC (-112ºF to ‑76ºF), where it can remain for up to 6 months. The vaccines are shipped in specially-designed boxes that contain dry ice in order to achieve those low temperatures. The vaccine can be stored in these boxes for up to 30 days if the dry ice is refilled every three days.

According to the proposed changes, Pfizer’s vaccine can be stored for up to five days at average refrigerator temperature between 2⁰C and 8⁰C (36⁰F and 46⁰F) before it’s mixed with a saline diluent and administered to people. The vaccine is then administered to people at room temperature.

If the FDA approves the proposed label change, hospitals, pharmacies, and other centers that might be involved in the vaccination process would be able to store the drug at the proposed -25°C to -15°C (-13°F to 5°F) temperature for two weeks. After that, the drug can continue to be stored for an additional five days between 2⁰C and 8⁰C (36⁰F and 46⁰F) once it’s prepared to be administered. The new temperature recommendation could also help reduce the number of vaccines that are wasted, which is a key issue when supply remains low. The drugs can only be used within a certain window of time after being thawed.

https://bgr.com/2021/02/19/coronavirus-vaccine-pfizer-temperature-range-improvement/

Edited February 19, 2021 by vememah

[Moracikus]

Svi se sprdali sa Englezima kad su odlucili da produze razmak.

Meni uvijek izgledala kao pobjednicka taktika. Izreal bi recimo vec bio ispod 1000 slucajeva i 10 mrtvih 

[Moracikus]

Englezi su cak trebali svima da daju po pola doze sad bi bili na 40% i spasili hiljade zivota

[precog]

a da su dali cetvrt doze, ne bi ni imali vise koronu.

[Moracikus]

Stim sto se na uzorku od skoro 3000 ljudi se upravo pola doze sa 3 mjeseca razmaka pokazala veoma efikasna.