Showing posts with label Vaccine. Show all posts
Showing posts with label Vaccine. Show all posts

Monday, January 4, 2021

Modi's Vaccine Nationalism: India's Hasty Approval of Homegrown COVID19 Vaccine

Indian drug regulator has approved COVAXIN, a Covid19 vaccine developed by Bharat Biotech.  The approval has been granted without completing large-scale phase 3 trials in India, according to media reports. It is India's first indigenous vaccine co-developed with Pennsylvania-based startup Ocugen. Ocugen, led by Indian-American scientists, does not currently sell any products.  India is the world's second worst-hit country by the global coronavirus pandemic.  Critics say the hasty approval of the homegrown Indian vaccine is motivated by "chest thumping nationalism". 

US-Based Ocugen: 

How COVAXIN Works. Source: NY Times

Ocugen is a US-based biotech company. It has no track record. It has not developed any drugs and doesn't have any products to sell yet. This lack of experience makes Ocugen a strange choice for an international commercialization partner, according to an investment analysis published in the United States. The Food and Drug Administration has made it clear that it won't authorize a coronavirus vaccine without data from a phase 3 trial conducted in the United States. NASDAQ-listed Ocugen stock has soared since the approval of COVAXIN for use in India. 

Bharat Biotech:

Bharat Biotech is an Indian biotechnology company based in the South Indian city of Hyderabad. 

Dr. Krishna Ella, the Chairman of the Bharat Biotech, has claimed that they are "no way" inferior to Pfizer in terms of coronavirus vaccine. He also said that Bharat Biotech is the only firm to have published five articles on the Covid-19 vaccine process, according to media reports. 

COVAXIN Vaccine: 

Some critics have dismissed COVAXIN approval as a manifestation of "chest thumping nationalism". Bloomberg's Andy Mukherjee has a story entitled "COVAXIN: Science, not pride will help India build trust in this vaccine". 

Indian government's decision to authorize COVAXIN has been sharply criticized by public interest groups in India. “The decision to approve an incompletely studied vaccine, even under accelerated process, raises more questions than answers and likely will not reinforce faith in our scientific decision-making bodies,” Malini Aisola, of the All India Drug Action Network (AIDAN), an independent collective of healthcare non-profits, said in a statement.

COVID19 Pandemic:

India has been hit hard by the coronavirus pandemic with over 10 million infections, second only to the United States. Indian economy has shrunk by double digits. Tens of millions of daily wage earners who make up the bulk of India's workforce have lost their livelihoods. Prime Minister Narendra's Modi's decision to impose a sudden nationwide lockdown is blamed for it. 

Summary:

COVAXIN is India's first indigenously developed vaccine that has just been approved for emergency use in the country. It has been co-developed with US-based Ocugen. COVAXIN's hasty approval without any phase 3 efficacy data has come under  sharp criticism. Some critics have dismissed COVAXIN approval as a manifestation of "chest thumping nationalism". Bloomberg's Andy Mukherjee has a story entitled "COVAXIN: Science, not pride will help India build trust in this vaccine". 

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Monday, November 9, 2020

Turkish-Born Muslim Scientists Behind Pfizer's Successful COVID19 Vaccine

Pfizer has announced today that its COVID19 vaccine has been found to be more than 90% effective in its recently concluded large-scale trial. The two key scientists who developed this vaccine are Turkish-born Muslims named Dr. Ugur Sahin and his wife Dr. Ozlem Tureci, according to media reports.  The couple started BioNTech, a technology startup based in Germany, to develop treatments using messenger RNA (mRNA) technology. A Morocco-born Muslim scientist Dr. Moncef Mohamad Slaoui is leading Operation WARP Speed announced by President Donald Trump to rapidly develop and distribute a coronavirus vaccine in the United States. Covid19 pandemic is the biggest challenge the world faces today. Muslim scientists are in the forefront of dealing with this challenge. This is particularly notable in a world where Islamophobia has gone mainstream in recent years. 


Dr. Sahin and Dr. Tureci


The Scientist Couple:

Dr. Sahin, 55, is the son of a Turkish Muslim immigrant who worked at a Ford factory in Cologne, Germany. He is now among 100 richest Germans, together with his wife and fellow board member Dr. Oezlem Tuereci, 53, according to weekly Welt am Sonntag. 

Sahin had been working on mRNA technology with his wife Dr. Tureci for more than 25 years. The couple, both children of Muslim Turkish immigrants who met while working at a cancer clinic, sold their first company, Ganymed Pharmaceuticals AG, for $1.66 billion in 2016, according to the Wall Street Journal. Then they started BioNTech whose market value on NASDAQ has soared to $21 billion as of Friday’s close from $4.6 billion a year ago. 

Deal With Pfizer:

BioNTech was working with Pfizer to develop a new flu vaccine when Covid19 emerged in China. As the epidemic raged in China—making it a good place to hold vaccine trials—Dr. Sahin struck a deal with Shanghai Fosun Pharmaceutical Co., Ltd. to test candidates there. 

China soon lost its appeal as a potential vaccine testing ground because of the nation's progress in containing the virus. It prompted Dr. Sahin's call to Dr. Kathrin Jansen, head of Pfizer vaccine research, on March 1 to suggest a new partnership to test Covid-19 vaccines in the U.S. Dr. Jansen didn’t hesitate. She told Dr. Sahin, “Of course, I’d be interested. It’s probably the most important thing we’ll ever do,” she told the Journal. Dr. Sahin offered to split the remaining development costs as well as the profits down the middle. Dr. Jansen accepted, he said, and the two companies began work on the project even before signing a contract. Pfizer said Dr. Jansen agreed in principle to work with BioNTech.

Dr. Moncef Mohamed Slaoui: 

Earlier this year. President Donald Trump picked renowned Moroccan-born Muslim American immunologist Dr. Moncef Mohamed Slaoui to  lead  Operation Warp Speed, America's COVID-19 vaccine program. Trump has compared this vaccine effort with the Manhattan Project that developed the atomic bomb in the 1940s.

Dr. Moncef Slaou

Dr. Slaoui is a highly recognized scientist and a successful leader who has delivered as GSK's head of vaccines. He appears to have more of a can-do entrepreneurial approach to solving problems. He has recently been running a life-sciences VC fund in Philadelphia.

Announcing the appointment, Trump described Slaoui as “one of the most respected men in the world in the production and, really, on the formulation of vaccines.” “Operation Warp Speed’s chief scientist will be Dr Moncef Slaoui, a world-renowned immunologist who helped create 14 new vaccines,” Trump said at a White House news briefing. “That’s a lot of our new vaccines — in 10 years, during his time in the private sector,” he added.

Dr. Slaoui is an ethnic berber born in the Moroccan coastal city of Agadir which is famous for its beaches, according to Dr. Juan Cole of University of Michigan at Ann Arbor. Dr. Cole has hailed Dr. Slaoui's appointment in his blog post titled "I guess “Islam” doesn’t Hate us After All: Trump pins hopes for Vaccine on Muslim-American Slaoui".

Dr. Slaoui is listed as an author on over 100 scientific papers. He worked for 30 years at GlaxoSmithKline (GSK), and for a decade he headed up its worldwide Research and Development department. He also served for two years as chair of GSK Vaccines, notes Yahia Hatim at Morocco World News.  Slaoui, a former professor of immunology at the University of Mons, Belgium, said that Operation Warp Speed will make available a few hundred million doses of a COVID-19 vaccine by the end of the year.

Muslim Americans in Health Care:

There are a large number of Muslim Americans on the frontlines of war against the novel coronavirus. Among them is Dr. Syra Madad, Pakistani-American head of New York City’s Health and Hospitals System-wide Special Pathogens Program, who is featured in a 6-part Netflix documentary series "Pandemic: How to Prevent an Outbreak".

Pakistani-American doctors are the 3rd largest among foreign-educated doctors in America. Among the notable names of Pakistani-American doctors engaged in the fight against Covid-19 are: Dr. Saud Anwar in Connecticut, Dr. Gul Zaidi in New York and Dr. Umair Shah in Texas. Their work has received positive media coverage in recent weeks.

Dr. Saud Anwar, a Connecticut pulmonologist and state senator, came up with a ventilator splitter to deal with the shortages of life-saving equipment. Dr. Gul Zaidi, an acute-care pulmonologist in Long Island, was featured in a CBS 60 Minutes segment on how the doctors are dealing with unprecedented demands to save lives. Dr. Umair Shah was interviewed about his work by ABC TV affiliate in Houston, Texas.

Summary:

Pfizer has announced that its COVID19 vaccine is 90% effective. The couple behind this success are the husband-wife team of Turkish Muslim scientists who together founded BioNTech in Cologne, Germany.  The US vaccine effort named Operation WARP Speed is also led by a Muslim American scientist Dr. Moncef Mohamed Slaoui. Covid19 pandemic is the biggest challenge the world faces today. Muslim scientists are in the forefront of dealing with this challenge. This is particularly notable in a world where Islamophobia has gone mainstream in recent years. 


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Thursday, June 4, 2020

Antibodies Testing in Karachi Reveals COVID19 Exposure Runs in Double Digits

Antibodies testing of 7,000 adults in Karachi reveals that as many as 15% of them have already been exposed to COVID19 without experiencing symptoms, according to a study by Dr. Wajiha Javed, an epidemiologist and head of public health and research at Getz Pharma in Pakistan. This data raises the possibility that millions of Pakistanis may have already been exposed to coronavirus. It takes at least 40% of the population to be exposed to build herd immunity. This may be the only way to normalcy unless there is a vaccine available sooner.

Human Immune Response:

Human body naturally produces antibodies to fight viruses of various kinds, including the coronavirus. Presence of antibodies in a person confirms that he or she has been exposed to a virus regardless of symptoms. Serology tests can detect body's immune response to even a low-level viral load. Such an immune response also occurs to a vaccine which does not make you sick but helps build immunity. More low level exposure to viruses in large numbers of people is in fact a good thing because it helps build herd immunity. However, the most vulnerable population such as the elderly must be isolated until herd immunity is achieved. It takes at least 40% of the population to be exposed to build herd immunity.

Coronavirus Antibodies

Getz Study:

Getz Pharma's Dr. Wajiha Javed told me in the latest update on her ongoing work that serology tests have so far been administered to 7,000 adults aged 18-65 over the last 6 weeks in Karachi. 15% of them have tested positive for COVID19 antibodies. People tested included those working for banks, restaurants, textile mills, factories, media and health care workers.

Antibody testing kits detect the response of the body rather than the virus or antigen itself. These tests do not have the issue of low viral load. Antibody tests can detect exposure to Covid-19 even in asymptomatic cases. Generally, antibody testing kits have a high level of accuracy, especially on sequential testing. The kit Getz Pharma has been using has a sensitivity (the ability to correctly detect positive cases) of 95.3% and specificity (the ability to correctly detect negative cases) of 98.7% for IgG, and the sensitivity is 86.48% and specificity is 95.18% for IgM, according to Dr. Wajiha Javed.

Pakistan COVID19 Death Rate Among The World's Lowest. Source: Our World in Data 

Asymptomatic Carriers: 

Over 90% of those who tested positive in Karachi did not have any symptoms or had only mild symptoms, Dr. Wajiha Javed recently wrote in Dawn newspaper.  But some were infectious and they were spreading the virus to others. Because of their non-existent or mild symptoms, they had not reached out to a PCR testing facility to get tested for Covid-19, and were only incidentally picked out for the antibody test during Getz's study. This data raises the possibility that millions of Pakistanis may have already been exposed to coronavirus.

Summary:

As many as 15% of Karachi adults have been exposed to COVID19 with over 90% of them showing no symptoms, according to a Getz Pharma study in Pakistan. People tested included those working for banks, restaurants, textile mills, factories, media and health care workers. Human body naturally produces antibodies to fight viruses of various kinds, including the coronavirus. Presence of antibodies in a person confirms that he or she has been exposed to a virus regardless of symptoms. It can even detect body's immune response to a low-level viral load. Getz Pharma's antibodies test data suggests the possibility that millions of Pakistanis may have already been exposed to coronavirus.  Such an immune response also occurs to a vaccine which does not make you sick but helps build immunity. More low level exposure to viruses in large numbers of people is in fact a good thing because it helps build herd immunity. This may be the only way to normalcy unless there is a vaccine available sooner.

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Haq's Musings

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