Covid-19 Cepiva

Ytbnd · 24. avg 2021

Does the FDA think these data justify the first full approval of a covid-19 vaccine?

Does the FDA think these data justify the first full approval of a covid-19 vaccine? - The BMJ

The FDA should demand adequate, controlled studies with long term follow up, and make data publicly available, before granting full approval to covid-19 vaccines, says Peter Doshi On 28 July [...]More...

blogs.bmj.com

Luknje, veliko lukenj.

And so the recent reports from Israel’s Ministry of Health caught my eye. In early July, they reported that efficacy against infection and symptomatic disease “fell to 64%.” By late July it had fallen to 39% where Delta is the dominant strain. This is very low. For context, the FDA’s expectation is of “at least 50%” efficacy for any approvable vaccine.

Now Israel, which almost exclusively used Pfizer vaccine, has begun administering a third “booster” dose to all adults over 40. And starting 20 September 2021, the US plans to follow suit for all “fully vaccinated” adults eight months past their second dose.

Vs

And it’s hard to imagine how the Delta variant could play a real role here, for 77% of trial participants were from the United States, where Delta was not established until months after data cut-off.

Until new clinical trials demonstrate that boosters increase efficacy above 50%, without increasing serious adverse events, it is unclear whether the 2-dose series would even meet the FDA’s approval standard at six or nine months.

luka51 · 24. avg 2021

Uporabnik AndY1 je napisal:
Khm, poglej moja zadnja dva posta.

Daj jih še ti za hec.
Predvem ta dva dela:
-The study found that vaccination with influenza vaccines containing the 2009 H1N1 virus strain used in the United States was not associated with an increased risk for narcolepsy.
- In 2018, a study team including CDC scientists analyzed and published vaccine safety data on adjuvanted pH1N1 vaccines (arenaprix-AS03, Focetria-MF59, and Pandemrix-AS03) from 10 global study sites. Researchers did not detect any associations between the vaccines and narcolepsy.

mosseero · 24. avg 2021

Zdaj bo pa spet tišina do nadaljnega, ker si mu zamajal svet in bo iskal potrditev svojih nebuloz na YT.

ynos · 24. avg 2021

Ena za AndY1 , ziher znas utemeljiti.

BojanP · 24. avg 2021

Je že na prejšni strani. Da on ga je kupil iz indije za 55usd s poštnino in tako povzročil kaznivo dejanje.

nemenabijat · 24. avg 2021

Uporabnik ales85 je napisal:
Ta isti IJS, ki je ze prej povsem mimo ustrelil? Do petka je pa res jaka muda "napovedovati".

IJS: Se ukvarjamo z atomsko fiziko, v prostem času pa napovedujemo razvoj epidemije. :aplauz:

Ytbnd · 24. avg 2021

ynos

MALMED will approve Ivermectin, but then will beg the pharmaceutical companies to bring it because "it is not a cure for business" - Free Press

The Drug Agency MALMED is seriously determined to bring the drug Ivermectin to Macedonia, claims for "Free Press" the director of the institution Ljirim Shabani. Get the most important news, for free on Viber According to him, it is a matter of days before all administrative procedures are...

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AndY1 · 24. avg 2021

Uporabnik BojanP je napisal:
Je že na prejšni strani. Da on ga je kupil iz indije za 55usd s poštnino in tako povzročil kaznivo dejanje.

A lahko nehaš lagati ker te bom prijavil zaradi obrekovanja.

AndY1 · 24. avg 2021

The SARS-CoV-2 Delta variant is poised to acquire complete
resistance to wild-type spike vaccines

https://www.biorxiv.org/content/10.1101/2021.08.22.457114v1.full.pdf

Abstract:
mRNA-based vaccines provide effective protection against most common SARS-CoV-2 variants.
However, identifying likely breakthrough variants is critical for future vaccine development. Here,
we found that the Delta variant completely escaped from anti-N-terminal domain (NTD)
neutralizing antibodies, while increasing responsiveness to anti-NTD infectivity-enhancing
antibodies. Although Pfizer-BioNTech BNT162b2-immune sera neutralized the Delta variant,
when four common mutations were introduced into the receptor binding domain (RBD) of the
Delta variant (Delta 4+), some BNT162b2-immune sera lost neutralizing activity and enhanced the
infectivity. Unique mutations in the Delta NTD were involved in the enhanced infectivity by the
BNT162b2-immune sera. Sera of mice immunized by Delta spike, but not wild-type spike,
consistently neutralized the Delta 4+ variant without enhancing infectivity. Given the fact that a
Delta variant with three similar RBD mutations has already emerged according to the GISAID
database, it is necessary to develop vaccines that protect against such complete breakthrough
variants.

kalbo · 24. avg 2021

Uporabnik AndY1 je napisal:
A lahko nehaš lagati ker te bom prijavil zaradi obrekovanja.

O fak. Si res to napisu? Ti pa si zglajzal. Si že komentiral svoje limanje zavajujočih posnetkov, ki niso imeli nobene povezave s cepljenjem? Pazi da tebe ne prijavimo zaradi očitnega zavajanja.

AndY1 · 24. avg 2021

https://twitter.com/i/web/status/1429894624005476353

johan_blond · 24. avg 2021

Najnovejša Pfizerjeva študija o njihovem cepivu in o učunkovitosti (> 3 mio cepljenih).

Par povzetkov:
- bolj kakor delta sama ima vpliv pojemajoča imunost zaradi cepiv, prvi mesec zaščita 88 %, po petih mesecih pade na 47 %.
- pri delti je zaščita prvi mesec 93 %, že po 4 mesecih pade na 53 % (samo za občutek, interval zaupanja je 39 % - 65 %)

Findings: For fully vaccinated individuals, effectiveness against SARS-CoV-2 infections was 73% (95%CI: 72‒74) and against COVID-19-related hospitalizations was 90% (89‒92). Effectiveness against infections declined from 88% (86‒89) during the first month after full vaccination to 47% (43‒51) after ≥5 months. Among sequenced infections, VE against Delta was lower compared to VE against other variants (75% [71‒78] vs 91% [88‒92]). VE against Delta infections was high during the first month after full vaccination (93% [85‒97]) but declined to 53% [39‒65] at ≥4 months. VE against hospitalization for Delta for all ages was high overall (93%).

Six-Month Effectiveness of BNT162B2 mRNA COVID-19 Vaccine in a Large US Integrated Health System: A Retrospective Cohort Study

Background: Vaccine effectiveness (VE) studies have not differentiated the impact of Delta from potential waning immunity on recent observed reductions in effec

papers.ssrn.com

kalbo · 24. avg 2021

In spet vse tiho je bilo. No, bo kaj? Boš priznal, dy si zahebal?

D_K · 24. avg 2021

ksz... eno leto kasneje. Predvidevam, da AndY1 še vedno ni cepljen

jest5 · 24. avg 2021

Je. Z YT.

kalbo · 24. avg 2021

Ni, po tistem, ko je zbrisal z vrste, je postal hard core antiwakser in že celo večnost googla nebuloze.

AndY1 · 24. avg 2021

Uporabnik johan_blond je napisal:
Najnovejša Pfizerjeva študija o njihovem cepivu in o učunkovitosti (> 3 mio cepljenih).

Par povzetkov:
- bolj kakor delta sama ima vpliv pojemajoča imunost zaradi cepiv, prvi mesec zaščita 88 %, po petih mesecih pade na 47 %.
- pri delti je zaščita prvi mesec 93 %, že po 4 mesecih pade na 53 % (samo za občutek, interval zaupanja je 39 % - 65 %)

Findings: For fully vaccinated individuals, effectiveness against SARS-CoV-2 infections was 73% (95%CI: 72‒74) and against COVID-19-related hospitalizations was 90% (89‒92). Effectiveness against infections declined from 88% (86‒89) during the first month after full vaccination to 47% (43‒51) after ≥5 months. Among sequenced infections, VE against Delta was lower compared to VE against other variants (75% [71‒78] vs 91% [88‒92]). VE against Delta infections was high during the first month after full vaccination (93% [85‒97]) but declined to 53% [39‒65] at ≥4 months. VE against hospitalization for Delta for all ages was high overall (93%).

Six-Month Effectiveness of BNT162B2 mRNA COVID-19 Vaccine in a Large US Integrated Health System: A Retrospective Cohort Study

Background: Vaccine effectiveness (VE) studies have not differentiated the impact of Delta from potential waning immunity on recent observed reductions in effec

papers.ssrn.com

Poglej priponko 47914

Torej drži to, kar sem pred kratkim polinkal, da je učinkovitost Pfizerjevega cepiva po 6 mesecih proti Delta sevu le še 36%. Karkoli pod 50% pa pade izven EUA odobritve - očitno že po 4 mesecih, po tvojih podatkih.

kalbo · 24. avg 2021

No, bo kaj? Cepijo otroke na silo al si mal zabluzil?

AndY1 · 24. avg 2021

Uporabnik kalbo je napisal:
No, bo kaj? Cepijo otroke na silo al si mal zabluzil?

johan_blond · 24. avg 2021

Uporabnik AndY1 je napisal:
Torej drži to, kar sem pred kratkim polinkal, da je učinkovitost Pfizerjevega cepiva po 6 mesecih proti Delta sevu le še 36%. Karkoli pod 50% pa pade izven EUA odobritve - očitno že po 4 mesecih, po tvojih podatkih.

Ne, samo pravi čas je potrebno dati poživitveni odmerek (booster).

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