Tag Archives: Pfizer

Stanford’s Dr. Nirav Shah on Vaccines VS. Variants

Breaking news that virulent variants from Brazil, South Africa, and the UK are multiplying across borders even as homegrown strains are mutating on US soil, has raised a number of questions.

Are variants more contagious?
Will they cause worse infections?
Are current vaccines effective against mutating variants?
And should we take different precautions to keep safe?

Dr. Nirav Shah, MD, MPH, of Stanford University’s Clinical Excellence Research Center, fielded questions and concerns from ethnic media reporters at a press briefing on March 19. Along with other COVID 19 experts from the Bay Area, Dr. Shah shared information about new strains of the virus and safety net information for communities of color who want to sign up to get their vaccine shot.

“We cannot start to celebrate just yet,” said Shah, even though America reached an important milestone when the 100 millionth vaccine was administered on March 19.

The Story of Virus Variants

The emergence of variants has raised the specter that the current generation of vaccines might be rendered obsolete before they have even been fully rolled out. Are variants gaining ground and will they be immune to distinct vaccines before we reach herd immunity?

“It’s a race between how fast we get people fully vaccinated versus the level of disease in a community and how much transmission is going on,” explained Shah, about how a variant becomes dominant.

In heavily infected communities, the more virus particles there are, the greater the chance of one being different. All you need is a spike protein change, said Shah, which will give the variant a better chance of attaching to cells, so it spreads better and faster, becoming the dominant strain.

Simultaneously, as more people get vaccinated to combat COVID19, “the selective advantage of some particles relative to other particles, allow them to spread much faster.”

Now the race is on to get everyone vaccinated before the B.1.1.7. variant – the most dominant variant takes over.

“The story of virus variants is the story of evolution and natural selection,” added Shah.

Investigations of Variants

Currently, the CDC and WHO are studying the spread of three designated variants. Variants of interest -like the P2 which have ‘caused a cluster of infections’  in some countries, seem to be driving a surge in cases, though less is known about their transmissibility and lethality, or even if vaccine recipients are ‘fully neutralized against them or not’.

Their genetic sequence has some changes which suggest they may be more contagious, said Shah, and likely to be resistant to immunity bestowed by vaccines, treatments, or tests.

People are at greater risk from variants of concern that could reinfect survivors of certain Covid19 strains. Therapies and vaccines may be less effective against these strains which have “proven to be more contagious and cause more severe disease,” explained Shah.

Recent studies report that COVID-19 survivors and fully vaccinated people seem able to fight off infection from the virulent B.1.1.7 variant but may have less protection against the B.1.3.5.1 variant. Shah referred to research that shows the B.1.1.7 variant spreads about 50% faster and is more lethal, relative to prior strains of the virus.

The good news is that the existing range of vaccines (Pfizer, Moderna, Oxford/Astra Zeneca, and Novavax) have proven effective against this variant.  But less is known about the transmissibility and lethality of the P1, B.1.4.2.7, and  B.1.4.2.9 strains.

So far, however, assured Shah, no variants have met the definition for variants of high consequence which refer to strains that cause “more severe disease, more hospitalizations, and have been shown to defeat medical countermeasures” – like vaccines, anti-viral drugs, or monoclonal antibodies.

In the contest between vaccines and variants, “We will win the race by …vaccinating people as quickly…and broadly as possible” noted Shah.

An Annual Shot

Infectious disease experts liken variants to flu viruses which require new flu vaccines every year; scientists are even considering the possibility of multivalent vaccines designed to immunize against two or more strains of the virus.

“It’s a race of the mutant viruses against the vaccines…and to date, none of the mutants have escaped fully the major vaccines. The hope is that with minor modifications, we can get the continued evolution of the vaccines to match the evolution of the viruses.” It wouldn’t be surprising if the COVID vaccine was administered like a flu shot every year, added Shah.

Getting to Herd Immunity

The likelihood of reaching herd immunity will be a reality if at least  70% or more of the population are resistant to existing strains of the virus. However, as states relax public health restrictions as well as mask and social distancing mandates, herd immunity may be challenging to achieve.  “More people getting infected simply means more chance of variants,” cautioned Shah.

I asked Dr. Shah if we would need a new generation of vaccines before the current vaccine roll is complete and if boosters would be introduced. “I am an optimist”, said Shah. “I imagine we would have booster shots by the fall but what’s important is that we all get that first shot, and make sure the vulnerable and elderly get theirs. That will make us collectively win”.

Dr. Shah reiterated that the Moderna, Pfizer, and Johnson & Johnson vaccines authorized by the Food and Drug Administration (FDA) for emergency use, are still the most powerful tools to fight all the strains of COVID-19.

“This is a race for the world,” said Dr. Nirav Shah. “We know the virus doesn’t respect any borders, and so we should be as broad as possible in our thinking about getting the vaccine to everyone across the world.”

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Meera Kymal is the Contributing Editor at India Currents

The Virus & The Vaccine

Getting the COVID19 vaccine out of the freezer and into people’s arms has been slow. And, even as people battle unsympathetic websites to find slots for a shot, there still are many unanswered questions.

Will people who have been vaccinated still be asymptomatic and carriers who could infect others?

Will non-vaccinated people still need to wear PPE when interacting with them?

Will the vaccine protect against two new contagious strains of the virus?

What will the Biden administration do differently in its COVID19 response?

These questions and more, were answered by experts at an Ethnic Media Services briefing on January 13.

One of the biggest concerns to the country is the slow pace of the vaccine roll out. Though the US has 20 million doses of the Pfizer & Moderna vaccine, we face innumerable challenges at both the federal and state level, in getting the vaccine out to people. Only 5 million vaccines have been distributed as of January  11th.

According to Dr. William Shaffner, Professor of Preventive Medicine and Health Policy, and Professor of Medicine in the Division of Infectious Diseases at Vanderbilt University, a number of bottle necks choked a smooth vaccine roll out. At the national level, the uncertainty in vaccine shipments put a strain on the local level. States were not sure when vaccines would arrive, sometimes delivery was delayed, or fewer doses were received than anticipated. Occasionally shipments were sent to the wrong state in error.

Dr. William Shaffer

The Pfizer Deep Freeze

A key challenge for local distribution outlets was storing the Pfizer vaccine which requires “a really deep freeze” to keep it stable and intact. So only large medical centers with appropriate freezer storage capacity and personnel trained to handle it, first received the vaccine.  Fortunately, the Moderna vaccine does not need similar storage requirements and was distributed more easily, so vulnerable populations and frontline healthcare workers in long term care facilities, nursing homes and smaller community hospitals were able to access the vaccine.

Not Just Another Flu Campaign

“Quite frankly,” said Dr. Schaffer, many facilities assumed it would be “just another flu campaign,” but they were wrong. Insufficient preparation to administer the COVID19 vaccine rather “gummed up the works.”

                      Dr. Robert Wachter

California did get the science right, added Dr. Robert M. Wachter, Professor and Chair of Medicine at UCSF, “but did not get the logistics right.” Based on the way California managed its PPE and testing protocols, he was not surprised that vaccine distribution fared poorly. It’s a complicated process which ‘would have benefitted from a thoughtful national plan’ to determine for example, how to get a vaccine from a manufacturing plant in Michigan into a Fedex box that arrives in a central Californian distribution center. Glitches occurred because states, left to devise their own distribution process, “handed off responsibility to local institutions” which improvised protocols in “the last mile” of the roll out.

The lack of national guidance allowed too much “wiggle room” for error, stated Dr. Wachter.

Health Equity Gridlock

Another problem was created by rules about which cohorts got the vaccine first in a well-meaning effort to ensure health equity and that certain groups  – frontline healthcare workers, the elderly and essential workers – were prioritized for the vaccine. But how does a “Walgreens decide if you are a pre-school teacher or a grocery store worker or someone with a pre-existing condition,” argued Dr. Wachter. Do you need a note from your doctor or employer? “I haven’t received a convincing answer from anybody.”

‘We’ll Figure It Out’ Won’t Work

The lesson to learn is that “we’ll figure it out is not going to work with COVID19,” declared Dr. Wachter. He called it ‘scandalous’ that only 30% of all vaccines distributed have been injected when “millions of people should have received the vaccine by now.”

Congress only passed a coronavirus relief bill in late December 2020, to provide supplies necessary for distributing and administering the COVID-19 vaccine.

What we have  is a “9/11 or a Pearl Harbor worth of people dying a day” when we should be treating the distribution of the vaccine as an emergency, added Dr. Wachter.

Vaccines Going to Waste

Stories about vaccines going to waste make great news stories, but that’s not the real problem, said Dr. Shaffer. The issue is that doses are sitting in refrigerators and freezers but not making it into the final phase of delivery.

At UCSF, medical, 84% of vaccines have been distributed -15 thousand of about 18 thousand doses have been injected. The worry is how doses will make their way into rural or underserved communities.

Interestingly, Dr Shaffer reported that at Vanderbilt, a survey of healthcare providers found that they were hesitant and skeptical about the vaccine before it arrived. Vanderbilt responded with a major effort to educate its staff and address concerns to reassure reluctant people and change their minds. For example, the program had to counter fears  that the vaccine is not safe for pregnant women.

Both physicians reiterated that the vaccines were safe and effective to use.

Single or Double Dose

Data from all clinical trials find that two doses are required. The first shot offers partial protection after ten days and up to 80% to 90% protected  up to the minute before getting the second dose. “The second dose boosts  you up to the ultimate number of 95% and creates more durable immunity,” confirmed Dr. Wachter.

While models show that giving more people a first shot of the vaccine will save more lives than withholding doses for the follow up shot, there are legitimate concerns about delaying the second dose – will immunity fall off, will it promote mutations by having more people partly vaccinated, or will people forget to come back for their second dose? A single dose only will not work in the long term, but deferring a second dose will get more people vaccinated sooner. So the Biden administration’s plan to get more first doses out is ‘a good strategy’ agreed Dr. Shaffer.

Will You Still Be Contagious?

Preliminary data from a Moderna study indicated that ‘a substantial proportion of people vaccinated would not be able to transmit the virus. However, until final data sounds the all clear, warned Dr. Shaffer, people should continue to observe precautions with masks and social distancing.

Biden Roll Out

The best first step for the new administration must be to lead its Covid19 response based on science and clearly communicate its national policy, emphasizing “public health and scientific principles,”  said Dr. Shaffer. They also need to address the bottlenecks in vaccine distribution and reinforce they will work together with state and local levels to troubleshoot and resolve problems. Instituting a federal policy to ensure consistency in the COVID19 response across the country will be invaluable, he added.

Challenges Ahead

There is a real risk of politically driven resistance to the vaccine especially in rural areas and persuading people that it is safe and necessary will be quite difficult, Dr. Shaffer pointed out. But as demand grows for the vaccine, websites will have to handle thousands of people going online to make appointments, and venues will have to manage large cohorts arriving for their shot. A fair system needs to be established to ensure health equity in who gets the vaccine.


Meera Kymal is the Contributing Editor at India Currents
Image by Wilfried Pohnke from Pixabay

Pfizer’s Vaccine Expert Discusses Allocating Doses For Low Income Communities

Dr. Advait Badkar, Senior Director of Pfizer’s Drug Design Team.

Radha Rangarajan, CSO of a medical devices company, and healthcare journalist Sujata Srinivasan, interviewed Advait Badkar, a Senior Director in Pfizer’s Drug Product Design and Development organization. Badkar is leading the efforts on the Pfizer-BioNTech COVID-19 vaccine program with respect to the formulation and process development, scale-up, technology transfer, and registration across global markets. The team Badkar heads specializes in novel delivery technologies with emphasis and expertise in nanoparticle-based modalities.

IC: Are there any differences in immunogenicity in subpopulations? 

Pfizer and BioNTech’s Phase 3 clinical trial data demonstrated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. Efficacy was consistent across age, gender, race, and ethnicity demographics. 

IC: Participants enrolled in Pfizer’s clinical trials were known not to have been infected previously with COVID-19, for obvious reasons. But now that the vaccine is publicly available, it is not possible to test every person before vaccinating. In India, 70%-80% of people have the asymptomatic disease and are unaware of their COVID-19 status. Are any studies planned to assess the safety and efficacy of the vaccine in previously exposed populations? 

Yes. Immunity after vaccination is a question we continue to explore in our research. The duration of immunity after COVID-19 requires observing a large number of people who have had the disease once until some get it a second time. Because the first known cases of COVID-19 only occurred in December 2019, there hasn’t been enough time to observe a significant number of second illnesses to know the duration of natural protection. 

We will better understand transmission when we have data on protection for those who were previously exposed to SARS-CoV-2 or infected with COVID-19, asymptomatic disease and severity of the disease. Our trial will continue to study those areas to determine the full protection and potential of the vaccine. 

IC: Even though the science behind mRNA vaccine is not new, some fear that it might alter the genetic makeup, or cause other irreversible side effects. How is Pfizer’s outreach arm dispelling these myths?   

There is no evidence to support that notion. To the contrary, the mRNA platform is well suited for a pandemic response on many levels.  

First, one aspect of safety – unlike some conventional vaccines, mRNA vaccines are non-infectious, and there is no need for a viral vector to deliver the mRNA vaccine. Second, because no viral vector is used, mRNA vaccines pose no risk of an anti-vector neutralizing antibody response, thereby permitting repeated boosting, which may be important if additional vaccinations are recommended in the future.  Third, speed, mRNA technology enables rapid development if the vaccine needs to quickly adapt to potential mutations. mRNA vaccines have an efficient, fast production process, without the need for complex mammalian cell systems.

IC: Is there any plan to simplify the vaccination protocol to one dose? 

No. Pfizer and BioNTech’s Phase 3 study for the COVID-19 vaccine was designed to evaluate the vaccine’s safety and efficacy following a 2-dose schedule, separated by 21 days. The study concluded that the two doses are required to provide the maximum protection against the disease, a vaccine efficacy of 95 percent. 

IC: What are your thoughts on how to choose between the different vaccines?

At Pfizer, we understand that mitigating this global pandemic will require more than one vaccine and more than one company’s efforts. In March of 2020, Pfizer announced a 5-point plan calling on the biopharmaceutical industry to join the company in committing to an unprecedented level of collaboration to combat COVID-19. The industry responded. We are rooting for each other’s success and are confident that science will win.  

IC: What is the plan for a global supply? How will these be administered?

Pfizer and BioNTech are firmly committed to equitable and affordable access for its COVID-19 vaccine for people around the world. That commitment includes the allocation of doses for supply to low-income countries at a not-for-profit price. We are actively working with governments all around the world, as well as with global health partners to work towards fair and equitable access to our vaccine. We are also partnering with global health stakeholders to provide expertise and resources that can strengthen healthcare systems where greater support may be needed to deploy COVID-19 vaccines.  


Radha Rangarajan, Ph.D., is Chief Scientific Officer at HealthCubed Inc., a medical devices company. Prior to this, she was the founder and CEO of Vitas Pharma, a drug discovery and development company focused on novel drugs to treat multidrug-resistant infections. Radha has also worked in the Drug Discovery division of Dr. Reddy’s Laboratories. She received her bachelor’s degree from Stanford University, her Ph.D. from Rockefeller University, and was a postdoctoral fellow at the Harvard School of Public Health before moving back to India in 2003.

Sujata Srinivasan is an award-winning, independent business and healthcare journalist with the nonprofit Connecticut Health Investigative Team, whose grant-funded, data-driven reporting is carried by media outlets statewide. Previously, she was the Connecticut correspondent for Crain’s Business, business reporter at NPR’s regional station WNPR, U.S. correspondent for the Indian edition of Forbes, editor of Connecticut Business Magazine, and Interim Chief of Bureau at CNBC-TV 18, Chennai, India. You can follow her on Twitter @SujataSrini

Vaccines Bring Hope As COVID’s Third Wave Hits

In welcome news and within a week of each other, pharmaceutical giants Pfizer and Moderna announced breakthrough vaccines to combat the deadly coronavirus.

Pfizer and its German collaborator BioNTech, say their vaccine may be 90% effective in preventing COVID19 in participants, while Massachusetts-based Moderna expects a vaccine efficacy of 94.5%.

It’s a promising sign in the yearlong battle against an out-of-control pandemic. But though the trends in clinical trials seem positive, don’t throw out your face masks just yet. Experts warn of a long wait before the general public gets access to these newly minted vaccines.

It may be spring 2021 before the vaccine is widely available, which means the coronavirus will continue unabated for a few months more. COVID19 positivity rates reported by the Kaiser Family Foundation indicate that every state is now a blood-red ‘hotspot.’

As epidemiologists predicted, the third wave of coronavirus ‘forest fires’ are raging across the country with devastating effect. Currently the US leads the worldwide COVID death toll at over 250K and counting; we also have surpassed the 11 million mark in total COVID cases.

Despite warnings from experts, the federal coronavirus task force failed to deliver a comprehensive plan to counter the coronavirus threat. In fact, their strategy has been to “just let the infection run…which is not based on science,” remarked Dr. Ashish Jha, Dean, School of Public Health at Brown University, at a November 13th EMS briefing on the pandemic.

Without adequate federal funding or guidelines, each state has devised its own COVID19 response, but many did not heed the science on containing the spread.

That haphazard approach has had catastrophic consequences. Coronavirus cases are surging across the country. Since November 1, more than 1000 Americans have died of the coronavirus everyday and that number is steadily rising.

“This is not a surprise,” said Dr. Nirav Shah of Stanford University’s Clinical Excellence Research Center. “We predicted that in the fall, with people staying indoors and without broad protections ..such as masking, and not gathering in large groups, the numbers would continue to rise.”

Desperate to jumpstart their economies and reopen businesses and schools for a populace weary of quarantines, lockdowns and job losses, states made some bad choices by ignoring the science, said Dr.Jha. Several states (the Dakotas for example), raced to get back to normal by rolling back restrictions on large gatherings, travel and mask mandates.  According to the AARP only 35 states mandated face coverings in public. In Boston for example, schools closed but casinos stayed open. “Those are the wrong tradeoffs,” added Dr. Jha.

Inevitably, the subsequent spike in COVID19 rates has left the country scrambling to reimpose certain restrictions; even so, cases are mounting. The Kaiser Family Foundation reports hotspots in every state. In fact, ‘super spreader’ events are happening even at the White House.

The COVID Tracking Project currently (as of Nov. 15) has recorded a staggering 76,000 hospitalizations and over 155,000 confirmed cases a day. Experts at the briefing say that figure is much higher.

“Hospitals are being overwhelmed,” warned Dr. Tung Ngyuen (Professor of Medicine, UCSF), as they face bed shortages and burnout from healthcare workers who have “been doing this close to seven or eight months now.”

“We are in the worst moment in the pandemic” said Dr. Jha. He admitted he is baffled by the disconnect between how bad things are and how little attention the country is paying to it. “Right now we have about 150 thousand new cases being identified every day. But the truth is that the true number of infections occurring in the US right now, is between 300 and 400 thousand a day, maybe even closer to 500 thousand. We’re missing them because our testing is inadequate. All those people who are not being identified are of course out there spreading it to others. We are in a moment of exponential growth. We will get to two thousand deaths a day by mid-December.”

Calling it ‘unconscionable,’ Dr. Jha estimates that a 100 thousand more people will die between now and Inauguration Day (January 20th).

However, the advent of two promising vaccines may be a start in the right direction, even though the world has a long wait before it’s rescued from the virus.

“The reality is that it’s just 10 to 20 million doses maximum by the end of the year,” said Dr. Shah. “But it’s going to be some time before we get the kind of widespread availability of multiple vaccines, with secure supply chains to get everyone the two doses they need to actually start to achieve even partial herd immunity.”

It’s unlikely the ‘mRNA vaccines’, created from brand new technology and currently awaiting FDA approval, will arrive before the year end warn experts. Initially, limited supplies of the vaccine will likely be rationed and given to frontline healthcare workers, the vulnerable and the elderly. It could be spring before most of America gets the vaccine.

Though the clinical trials have produced strong results, enough data is not yet available to determine the longevity of the vaccine’s effects, or even its side effects. No one knows what level of protection it will offer younger vs older people, or whether we will need regular vaccinations like the flu shot.

The logistics of storing and distributing the vaccine are equally difficult. The vaccine has to be stored at extremely low temperatures which will make its distribution to remote and rural areas challenging and especially so among communities of color, where “skepticism is high and strong.”

Realistically, to reap the benefits of having a vaccine, states global health expert Tom Bollyky, at least 75% of the population will need to be vaccinated and that will take time.

“We are entering the hardest days of the pandemic,”  said Dr. Jha on Twitter. “The next two months will see a lot of infections and deaths. But he added, “There is a light at the end of the tunnel. Today, that light got a bit brighter.”

The disregard for advice from health experts and a lack of trust in science have precipitated some of the worst outbreaks so far, so it’s time say experts, for leaders and the general public to “rebuild the trust” and to stop politicizing the science.

Getting back to normal in the short term will mean that people have to take precautions to avoid transmissions until they can roll up their sleeves to be immunized.

Testing has to ramp up. But in the meanwhile, said Dr. Jha, “Wearing masks are a good thing to do for yourself, you family and community.”


Meera Kymal is the contributing editor at India Currents

Photo by CDC on Unsplash