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Coronavirus vaccine by October end, announces US pharma giant Pfizer

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American pharmaceutical giant Pfizer has announced that its ongoing development of a COVID-19 vaccine could be ready in five months period by October end. Pfizer is working on the vaccine project in collaboration with German firm Biontech.

Pfizer and its vaccine development German partner BioNTech announced on Friday, May 29, that the first participants have been given the doses in the US in the Phase 1/2 clinical trial for the BNT162 vaccine program to prevent COVID-19. “If things go well, and the stars are aligned, we will have enough evidence of safety and efficacy so that we can have a vaccine around the end of October,” said Pfizer CEO Albert Bourla.

The trial is part of the dosing of the first cohort in Germany that was completed last week. The Phase 1/2 study is designed to determine the safety, immunogenicity and optimal dose level of four mRNA vaccine candidates under study. The dose level escalation portion (Stage 1) of the Phase 1/2 trial in the U.S. will enroll up to 360 healthy subjects into two age cohorts (18-55 and 65-85 years of age). The first subjects immunized in Stage 1 of the study will be healthy adults 18-55 years of age, said the company.

Older adults will be immunized with a given dose level once testing and dose level in younger adults has provided initial evidence of safety and immunogenicity. Currently,the participants are being given these doses at NYU Grossman School of Medicine and the University of Maryland School of Medicine, with the University of Rochester Medical Center/Rochester Regional Health and Cincinnati Children’s Hospital Medical Center.

“The short, less than four-month timeframe in which we’ve been able to move from pre-clinical studies to human testing is extraordinary and further demonstrates our commitment to dedicating our best-in-class resources, from the lab to manufacturing and beyond, in the battle against COVID-19,” said Albert Bourla, Chairman and CEO, Pfizer.

Pfizer and BioNTech’s Vaccine Program

Pfizer and BioNTech’s development program includes four vaccine candidates, each representing a different combination of mRNA format and target antigen. The ongoing trial allows for the evaluation of the various mRNA candidates simultaneously in order to identify the safest and potentially most efficacious candidate in a greater number of volunteers.

“It is encouraging that we have been able to leverage more than a decade of experience in developing our mRNA platforms to initiate a global clinical trial in multiple regions for our vaccine program in such a short period. We are optimistic that advancing multiple vaccine candidates into human trials will allow us to identify the safest, most effective vaccination options against COVID-19,” said CEO and Co-founder of BioNTech, Ugur Sahin, whose firm will provide the vaccine from its GMP-certified mRNA manufacturing facilities in Europe.

Once this stage is successfully accomplished, both Pfizer and BioNTech plan to rapidly increase production of millions of vaccine doses in 2020, increasing to hundreds of millions in 2021. BioNTech and Pfizer will work supply the vaccine worldwide once regulators allow except China, where BioNTech has a collaboration with Fosun Pharma for BNT162 for both clinical development and commercialization.

Pfizer-owned sites in three U.S. states (Massachusetts, Michigan and Missouri) and Puurs, Belgium are being pressed into  manufacturing COVID-19 vaccine production, with more sites to be selected once the vaccine rolls out. Through its existing mRNA production sites in Mainz and Idar-Oberstein, Germany, BioNTech plans to ramp up its production capacity.

Hacked Wuhan lab details point out lab-origin of Coronavirus, WHO denies

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The World Health Organization (WHO) on Tuesday reiterated its earlier stand that the novel coronavirus originated in bats in China late last year and was not manipulated or constructed in a laboratory. This follows last week statement by US President Donald Trump that his government was trying to determine whether the virus emanated from a lab in Wuhan.

Refuting the reports which are pointing out that the virus was of lab origin and manipulated with HIV virus to make it deadly, WHO spokeswoman Fadela Chaib told a Geneva news briefing, “All available evidence suggests the virus has an animal origin and is not manipulated or constructed virus in a lab or somewhere else. It is probable, likely that the virus is of animal origin.”

Though it was not clear how the virus had jumped the species barrier to humans, there had “certainly” been an intermediate animal host, she stressed.

Wuhan lab origin?

Increasingly, reports have been going viral online stating that the virus has Wuhan lab origin and manipulated to mix it with HIV virus, making deadlier than any other virus known so far. The latest such report from the Washington Post on Tuesday revealed that hackers were able able to steal nearly 25,000 emails, passwords and classified documents allegedly belonging to the WHO, the Gates Foundation, as well as the Wuhan Institute of Virology, among other organizations. The details were posted on image board website 4chan, later shared on Pastebin, a text storage site, social media platforms Twitter and Telegram.

“Using the data, far-right extremists were calling for a harassment campaign while sharing conspiracy theories about the coronavirus pandemic,” said Rita Katz, Intelligence Group SITE’s executive director. “The distribution of these alleged email credentials were just another part of a months-long initiative across the far right to weaponize the covid-19 pandemic.”

Earlier, Luc Montagnier, a Nobel winning French scientist who co-discovered HIV (Human Immunodeficiency Virus) came out with a theory that the novel coronavirus came from a lab, denying WHO and Chinese government clims to the contrary. Montagnier claimed that the new ‘SARS-CoV-2’ virus came as a resultant in attempting to manufacture a vaccine for the AIDS virus, which may have got accidentally released. He claimed it in a podcast by Pourquoi Docteur and also in a TV interview on April 17.