4/26/2021   The Biden administration is expected to share AstraZeneca doses with other nations after a safety review, by Sheryl Gay Stolberg and David E Sanger, The New York Times

AstraZeneca’s vaccine, unlike those of Pfizer, Moderna and Johnson & Johnson, has not been granted emergency use authorization by the Food and Drug Administration. And the administration would not specify which countries will receive the vaccine.

 

Mr. Biden, who has already released a total of 4 million doses of AstraZeneca vaccine to Canada and Mexico, said last week that he was considering sending more overseas: “We’re looking at what is going to be done with some of the vaccines that we are not using,” the president said. “We’ve got to make sure they are safe to be sent.”

 

Jen Psaki, the White House press secretary, cautioned at a news conference that the donations of doses would not happen right away. She said about 10 million doses could be released “in the coming weeks” if the F.D.A. determines that the vaccine meets “our own bar and our own guidelines,” and that another 50 million doses are in various stages of production.

 

“Right now we have zero doses available of AstraZeneca,” Ms. Psaki said.

 

TweetOf92Percent2ndDoseCompliance

4/26/2021   Breathless headlines about 8% of Americans "skipping" their second doses aside, by Jeff Linder.

...it's actually pretty amazing, especially given that Americans pretty regularly get about HALF of recommended medical services.

 

12/2016   The Quality of Outpatient Care Delivered to Adults in the United States, 2002 to 2013, by David M. Levine, MD, JAMA Internal Medicine

4/25/2021    Millions Are Skipping Their Second Doses of Covid Vaccines, by Rebecca Robbins, The New York Times

Nearly 8 percent of those who got initial Pfizer or Moderna shots missed their second doses. State officials want to prevent the numbers from rising.

4/20/2021   Opinion: The covid-19 vaccines are an extraordinary success story. The media should tell it that way, by Leana S. Wen, M.D., The Washington Post

“So far, 5,800 fully vaccinated people have caught Covid anyway in the US, CDC says,” read one headline. “CDC reports 5,800 COVID-19 infections, 74 deaths in fully vaccinated people,” said another.

 

By themselves, the numbers sound concerning. But let’s take a closer look. An infection rate of 5,800 infections out of 77 million fully vaccinated people is less than 0.008 percent — a remarkably low rate. Compare this with 68,000 daily new infections in the United States — which, over a 30-day period, is nearly 100 times higher than the infection rate for those vaccinated. Put another way: A total of 5,800 infections among the inoculated is orders of magnitude better than 68,000 infections per day in the general population.

4/20/2021    Virginia Uses Emergency Alert System to Notify of Coronavirus Vaccine Availability, by Gregory S. Schneider and Erin Cox, The Washington Post

Virginia officials startled some residents Monday by using the wireless emergency alert system to send out notice that coronavirus vaccines are now available to everyone over age 16.

4/20/2021   ‘I’m still a zero’: Vaccine-resistant Republicans warn that their skepticism is worsening, by Dan Diamond, The Washington Post

Many vaccine-hesitant Americans are increasingly entrenched in their decisions to resist the shots, said Frank Luntz, a longtime GOP communications expert who convened Sunday’s focus group over Zoom.   Unlike a similar focus group five weeks ago, when most participants told Luntz and Frieden that the session persuaded them to get shots, attendees Sunday said they were swayed only moderately by doctors’ urging — or not moved at all.

 

“The further we go into the vaccination process, the more passionate the hesitancy is,” Luntz said after the session. “If you’ve refused to take the vaccine this long, it’s going to be hard to switch you.”

4/19/2021   The race to untangle the secrets of rare, severe blood clots after Johnson & Johnson vaccination, by Carolyn Y. Johnson, The Washington Post

A protein found inside platelets that also coated the surface of arteries and veins, called platelet factor 4, could bind strongly to heparin, forming a two-part complex.  In some people, when heparin and the protein bonded, the body’s disease-fighting system went on alert, triggering antibodies against platelet factor 4. The antibodies could activate platelets, but with seemingly contradictory consequences: Some platelets would clot, while others would vanish. The antibodies could damage the cells lining blood vessels, helping trigger clots in more ways than one.   It appears that something in the vaccine bound to platelet factor 4 and triggered a similar response.

 

“Just as an occasional patient zings off one of these huge responses after being given heparin and gets in trouble, the occasional person given these vaccines loses the regulatory control that keeps this immune response and zings off one of these high-titer antibody responses,” In five of the six U.S. patients who developed clots after receiving the Johnson & Johnson vaccine, physicians performed tests and found those same HIT antibodies. A 25-year-old man who received the vaccine in the clinical trial of the vaccine and suffered a brain clot also had HIT antibodies. The existence of those tests — and the ability to treat the condition — is a tribute to the years of experience studying HIT.

4/18/2021   Drones are delivering COVID-19 vaccines in Africa through ‘highways in the sky’, by Emmett Smith, Mashable

4/16/2021   Biden admin hunts for clues to J&J blood-clot mystery, by Erin Banco, Dan Goldberg, Rachel Roubein and Sarah Owermohle, Politico

The data gap may not be fully resolved by next Friday, when the Centers for Disease Control and Prevention’s vaccine advisory panel is set to gather for the second time to discuss the concerns about the shot

4/16/2021   The Blood-Clot Problem Is Multiplying, by Roxanne Khamsi, The Atlantic

The world is now engaged in a vaccination program unlike anything we have seen in our lifetimes, and with it, unprecedented scrutiny of ultra-rare but dangerous side effects. An estimated 852 million COVID-19 vaccine doses have been administered across 154 countries, according to data collected by Bloomberg. Last week, the European Medicines Agency, which regulates medicines in the European Union, concluded that the unusual clotting events were indeed a side effect of the AstraZeneca vaccine; by that point, more than 220 cases of dangerous blood abnormalities had been identified. Only half a dozen cases have been documented so far among Americans vaccinated with the Johnson & Johnson vaccine, and a causal link has not yet been established. But the latest news suggests that the scope of this problem might be changing.

4/16/2021   The Danger of a ‘Dudes Only’ Vaccine, by Katherine J. Wu, The Atlantic

The Johnson & Johnson shot is teetering on the precipice of becoming America’s “dudes only” vaccine.

 4/15/2021   COVID-19 Vaccines Are Entering Uncharted Immune Territory, by Katherine J. Wu, The Atlantic

A transplant infectious-disease physician at the University of Pittsburgh, told me that his team did not detect antibodies in about 46 percent of blood-cancer patients who had received both doses of the Pfizer or Moderna vaccine. Two studies out of Johns Hopkins University found no evidence of antibodies in 26 percent of people with rheumatic or musculoskeletal disease (a group that includes rheumatoid arthritis and lupus), and 83 percent of organ-transplant recipients, after their first dose of the Pfizer or Moderna vaccine.

 

For now, immunocompromised people will have to rely on those who can confidently derive protection from vaccines, such as household members, health-care providers, and other close contacts. That puts some of the onus on the rest of the world: “Every vaccine that goes into an arm is protection for these people,” Longbrake, of Yale, said.

4/14/2021   Livingston County COVID-19 vaccine tracker: 19% people fully vaccinated, by Chastity Laskey, Livingston Daily/ USA TODAY NETWORK

The five counties with the highest percentage of their population fully vaccinated in Michigan as of April 12 are Leelanau County (35%), Emmet County (32%), Grand Traverse County (31%), Schoolcraft County (30%) and Ontonagon County (30%).

4/14/2021   The Rural Pandemic Isn’t Ending, by Elaine Godfrey, The Atlantic

Rural Americans are twice as likely as people in urban areas to say they will “definitely not” get a shot, and nearly three-quarters of them identify as Republican or Republican-leaning, according to new survey data from the nonpartisan Kaiser Family Foundation. Rural Americans are more apt to see vaccination as a civil-liberties issue: “More (58%) rural residents view getting vaccinated as a personal choice rather than part of everyone’s responsibility to protect the health of others (42%),” the KFF survey found. (The reverse is true for urban residents.) This group is also much more likely than any other to say that the news media have exaggerated the pandemic’s seriousness, Liz Hamel, who directs KFF’s polling work, told me.

4/14/2021   CDC vaccine panel considers limiting J&J shot by age or sex, by Sarah Owermohle and Erin Banco, Politico

Officials stressed that these clots are of concern in part because the typical treatment for clotting — the blood thinner heparin — can make them worse.

4/14/2021   The mRNA Vaccines Are Looking Better and Better, by Sarah Zhang, The Atlantic

The blood-clot events with the AstraZeneca and J&J vaccines are so rare—appearing in one in 100,000 to one in 1 million vaccine recipients—that they would not have shown up in clinical trials, even ones conducted within more leisurely, non-pandemic timelines. (The COVID-19 vaccine trials, which generally included tens of thousands of participants each, were actually unusually large because researchers wanted data as quickly as possible.) “It’s true with all new medications of any sort. You only find rare events when things are rolled out to very vast numbers of people,” says John Grabenstein, the associate director of scientific communication for the Immunization Action Coalition, who used to work on vaccines for the pharmaceutical giant Merck. “One-in-a-million events are just barely measurable.” That faint signal is especially difficult to see against a noisy background: Some people get blood clots for reasons unrelated to the vaccine, too.

 

Some scientists now hypothesize that the immune reaction is triggered by some part of the adenovirus-vector technology. If that’s true, these blood clots might show up as a rare side effect with other adenovirus-vector vaccines. But they clearly are very infrequent. The AstraZeneca and J&J coronavirus vaccines are the first adenovirus-vector shots to even be deployed widely enough in the U.S. and Europe for such rare events to emerge, but vaccines including Russia’s Sputnik V,  China’s CanSino, and J&J’s Ebola vaccine also use the technology.

4/11/2021   Why covid arm and other post-vaccine rashes might actually be a ‘good thing’, by Marlene Cimons, The Washington Post

She thought the rash could be a side effect of the vaccine — in her case Moderna — and worried she wouldn’t be able to get her second dose.

“That was my biggest fear,” she says. “I wanted to be able to get it. I was more anxious about not getting it, than I was about the reaction itself.”

4/10/2021   Vaccines won’t be enough. New Covid variants have changed the game, by Susan Michie, et al, The Print

4/8/2021   Colorado vaccination site shuts down early after 11 people have 'expected' adverse reactions to the Covid-19 vaccine, officials say, by Rebekah Riess, Joe Sutton and Scottie Andrew, CNN

More than 1,700 people received the Johnson & Johnson vaccine on Wednesday at Dick's Sporting Goods Park, a soccer stadium where the state of Colorado and health care provider Centura Health operate a mass vaccination site. The 11 people reported feeling nauseous and dizzy after they were vaccinated, Colorado health officials said.

4/6/2021   Among 1.7 million fully vaccinated Michiganders, state identifies small number of COVID-19 infections and deaths, by Samuel Dodge, MLive.com

There are 246 fully-vaccinated Michiganders that tested positive for COVID-19, as well as three that died according to numbers from the state health department.  These cases account for just .0001% of the 1.7 million Michigan residents that received both doses of the COVID-19 vaccine as of March 30. The three patients that died were all age 65 or older.

 

The very small percentage of infections from fully vaccinated people falls well within the expected protectiveness of the Pfizer and Moderna vaccines, which provide 95% and 94% efficacy respectively. Health experts told MLive that 95% effectiveness means that if 1,000 people are fully vaccinated, you can expect around 50 infections among that group.

4/6/2021   Clear link between AstraZeneca vaccine and rare blood clots in brain, EMA official tells paper

“In my opinion we can now say it, it is clear that there is an association with the vaccine. However, we still do not know what causes this reaction,” Marco Cavaleri, chair of the vaccine evaluation team at the EMA, told Italian daily Il Messaggero when asked about the possible relation between the AstraZeneca shot and cases of brain blood clots.  The regulator has consistently said the benefits outweigh the risks as it investigates 44 reports of an extremely rare brain clotting ailment known as cerebral venous sinus thrombosis (CVST) out of 9.2 million people in the European Economic Area who have received the AstraZeneca vaccine.

4/6/2021   Biden Speeds It Up: All Adults Will Be Eligible for Vaccine by April 19, by Jamie Ross, Daily Beast

Last month, President Joe Biden promised America that every adult would be eligible for their first coronavirus vaccine by May 1. According to CNN, he’s now chopping two weeks off that deadline.

GlobalConvergenceInMaleLifeExpectancy Kashnitsky

4/5/2021   Demography 101:  What is Life Expectancy? and, even more important, What it Isn't, by Ilya Kashnitsky, PhD

 

 4/5/2021   The Story of One Dose, by Jeff Wise, Intelligencer

As an object, it’s not much: an inch and a half of glass with a stopper and some liquid inside. But a thimbleful of the stuff has amazing power — the ability to liberate us from our yearlong collective trauma. The fact that it’s available, scarcely a year after the start of a pandemic, is both an industrial miracle and a freakish stroke of luck; a decade ago, technology did not exist that could bring vaccines so quickly to the public’s arms.

 

The story of the vaccine’s path from development to mass distribution is a lesson in the power of the global capitalist system — the network of corporations and supply chains that, though it can suffocate and disempower us as individuals, can also summon forth immense material and intellectual resources and deploy them for the greater good.

 

To turn the original virus into a harmless vaccine, researchers had deleted genes the virus needs for replication; in order to make copies of itself, the Ad26.COV2.S vector required a special environment. The solution was to insert the virus’s missing genes into a unique human-cell line that had originated in the eye of a human fetus aborted in the mid-1980s. This genetically modified cell line was named PER.C6. Unlike normal human cells, which can multiply only so many times before dying, these cells are immortal; as long as they’re fed the right nutrients and kept at the right temperature, they can grow forever. Because PER.C6 contained the genes that Ad26 needed to reproduce, it held the key to growing the viral vectors.

 

The nurse chooses a needle based on the heft of your arm — an inch and a half for larger people, an inch otherwise — and pushes the tip into the rubber gasket atop the vial containing your dose. She slips the needle into your muscle. Inside your arm, 50 billion genetically engineered nanoscale robot assassins, carrying genetic payloads downloaded from the internet and bred in a soup of immortal human-eye cells, begin prying their way through your cells’ defenses.

4/5/2021   His Patient Refused the Vaccine. She Died of COVID in the ICU, by Michael Daly, Daily Beast

As he drove past reopened churches on Sunday, critical care nurse John Haacke figured Easter will prove to be yet another holiday followed by a surge in COVID-19.

 

“Things are picking up again. It seems like it won’t stop.” he said. “I have two sets of husbands and wives that died in the last week and a half, right in beds next to each other. I think in both families, the children infected them.”

 

None of the patients had been vaccinated. They either had not yet been able to get a shot or they had declined the opportunity. One clerical worker in her 50s had been given the chance but refused and ended up in the ICU with COVID-19.

 

The woman’s chest x-ray looked like a white sheet of paper, something increasingly common among recent patients.

 

“The worst chest x-rays I’ve ever seen in my life,” Haacke said. “Some of these x-rays, with an untrained eye you wouldn’t know there’s a lung that exists in there.”

 

The ICU team decided the woman’s best chance was extracorporeal membrane oxygenation (ECMO), where a machine pumps and oxygenates the blood outside the body.

 

“We tried to send her out Friday to put her on ECMO, but they didn’t have any beds available,” Haacke said. “It’s been that way.”

4/4/2021   Las goticas milagrosas del doctor Maduro, por Alberto Barrera Tyszka, The New York Rimes 

¿Por qué precisamente ahora, en la peor circunstancia, el chavismo rechaza vacunas? Porque su lógica es otra, porque su prioridad no son las víctimas, porque sus acciones no están destinadas a atender la emergencia sino —más bien— a aprovecharla en función de sus objetivos, de su plan de acumulación y permanencia en el poder.

 

You can hit the google translate button to read this in English, but it loses a little bite.

4/3/2021

2021 04 03 Share of pop with at least one does of vaccine

2021 03 28 CDC VaccinationsByCounty WaPost

4/3/2021   U.S. Taps Johnson & Johnson to Run Emergent's Troubled Vaccine Plant, by Sheryl Gay Stolberg, The New York Times

WASHINGTON — The Biden administration on Saturday put Johnson & Johnson in charge of a troubled Baltimore manufacturing plant that ruined 15 million doses of the Johnson & Johnson coronavirus vaccine and moved to stop the plant from making another vaccine by AstraZeneca, senior federal health officials said.

 

The extraordinary move by the Department of Health and Human Services came just days after officials had learned that Emergent BioSolutions, a contract manufacturer that has been making both the Johnson & Johnson and the AstraZeneca vaccines, mixed up ingredients from the two, which led regulators to delay authorization of the plant’s production lines.

 

The Department of Health and Human Services directed Johnson & Johnson to install a new leadership team to oversee all aspects of production and manufacturing at the Emergent Baltimore plant.

 

The ingredient mix-up, and Saturday’s move by the administration, is a significant setback and a public relations debacle for Emergent, a Maryland-based biotech company that has built a profitable business by teaming up with the federal government, primarily by selling its anthrax vaccines to the Strategic National Stockpile.

 

Emergent’s Baltimore plant is one of two that are federally designated as “Centers for Innovation in Advanced Development and Manufacturing” and were built with taxpayer support. Last June, the government paid Emergent $628 million to reserve space there as part of Operation Warp Speed, the Trump administration’s fast-track initiative to develop coronavirus vaccines.

 

Last month, Mr. Biden canceled a visit to Emergent’s Baltimore plant, and his spokeswoman announced that the administration would conduct an audit of the Strategic National Stockpile, the nation’s emergency medical reserve. Both actions came after a New York Times investigation into how the company had gained outsize influence over the repository.

3/8/2021   Biden Cancels Visit to Vaccine Maker After Times Report on Its Tactics, by Sheryl Gay Stolberg and Chris Hamby, The New York Times

Decisions about how to spend the repository’s limited budget are supposed to be based on careful assessments by government officials of how best to save lives, but The Times found that they were largely driven by the demands and financial interests of a handful of biotech companies that have specialized in products that address terrorist threats rather than infectious disease.

 

Chief among them is Emergent. Throughout most of the past decade, the government has spent nearly half of the stockpile’s half-billion-dollar annual budget on Emergent’s anthrax vaccines, The Times found.

 

In the competition for funding, products for pandemic preparedness — including N95s — repeatedly lost out, according to the Times investigation, which relied on more than 40,000 pages of documents and interviews with more than 60 people with inside knowledge of the stockpile.

 

The image of some health care workers wearing trash bags for personal protection has become an enduring symbol of the government’s failed response. Yet the government paid Emergent $626 million in 2020 for products that included vaccines to protect against a terrorist attack using anthrax.

 

For much of Emergent’s two-decade history, its primary product has been an anthrax vaccine, first licensed in 1970, that the company purchased in 1998 from the State of Michigan. Over time, the price per dose that the government agreed to pay Emergent increased nearly sixfold, accounting for inflation.

3/6/2021   A Who’s Who of Revolving-Door Influence at Emergent BioSolutions, by Sheryl Gay Stolberg and Chris Hamby, The New York Times

As in previous years, Emergent’s biggest single source of revenue in 2020 was products for the Strategic National Stockpile, the country’s emergency medical reserve, which was woefully ill prepared for the pandemic. Even with the country focused on Covid-19, the government last year paid Emergent $626 million for products that included anthrax and smallpox vaccines.

3/31/2021   Up to 15M Johnson & Johnson coronavirus vaccine doses ruined due to human error: NYT, by Eric Sagonowsky, Fierce Pharma

The manufacturing issues at J&J and AstraZeneca underscore the impressive production efforts underway at mRNA players Pfizer-BioNTech and Moderna. CDC data show 98 million Pfizer-BioNTech doses have been delivered to states, while 90 million Moderna doses have been sent. Moderna this week said it shipped its 100 millionth dose to the government.

3/31/2021   Johnson & Johnson’s vaccine is delayed by a U.S. factory mixup, by Sharon LaFraniere and Noah Weiland, The New York Times

The mistake is a major embarrassment both for Johnson & Johnson, whose one-dose vaccine has been credited with speeding up the national immunization program, and for Emergent, its subcontractor, which has faced fierce criticism for its heavy lobbying for federal contracts, especially for the government’s emergency health stockpile.

 

3/8/2021   How One Firm Put an ‘Extraordinary Burden’ on the U.S.’s Troubled Stockpile, by Chris Hamby and Sheryl Gay Stolberg, The New York Times

  • The shortage of lifesaving medical equipment last year was a searing example of the government’s failed coronavirus response. 
  • Explanations about what went wrong devolved into partisan finger pointing, with Mr. Trump blaming the Obama administration for leaving the cupboard bare, and Democrats in Congress accusing Mr. Trump of negligence.
  • An investigation by The New York Times found a hidden explanation: Government purchases for the Strategic National Stockpile, the country’s emergency medical reserve where such equipment is kept, have largely been driven by the demands and financial interests of a handful of biotech firms that have specialized in products that address terrorist threats rather than infectious disease.

4/1/2021   Biden Administration Announces Ad Campaign to Combat Vaccine Hesitancy, by Annie Karni, The New York Times

A new poll by the Kaiser Family Foundation this week found that the number of Black adults willing to be vaccinated had increased substantially since February. But 13 percent of respondents over all said that they would “definitely not” get a vaccine. Among Republicans and white evangelical Christians, almost 30 percent of each group said that they would “definitely not” get a shot.

 

“I’ve got some pockets where they cite religious reasons with the Johnson & Johnson vaccine,” said Shirley Bloomfield, the chief executive of N.T.C.A. — The Rural Broadband Association, who has been sharing with the White House what she hears from her group’s members. “There are a lot of pockets where people have already had Covid and a sense of, ‘Well, we’ve all already gotten it, so we’re not really pressed.’”

3/29.2021    Interim Estimates of Vaccine Effectiveness of BNT162b2 and mRNA-1273 COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Health Care Personnel, First Responders, and Other Essential and Frontline Workers — Eight U.S. Locations, December 2020–March 2021, by Mark G. Thompson, PhD; Jefferey L. Burgess, MD; Allison L. Naleway, PhD; Harmony L. Tyner, MD; Sarang K. Yoon, DO; Jennifer Meece, PhD; Lauren E.W. Olsho, PhD; Alberto J. Caban-Martinez, DO; Ashley Fowlkes, ScD; Karen Lutrick, PhD; Jennifer L. Kuntz, PhD; Kayan Dunnigan, MPH; Marilyn J. Odean, MS; Kurt T. Hegmann, MD; Elisha Stefanski; Laura J. Edwards, MPH; Natasha Schaefer-Solle, PhD; Lauren Grant, MS; Katherine Ellingson, PhD; Holly C. Groom, MPH; Tnelda Zunie; Matthew S. Thiese, PhD; Lynn Ivacic; Meredith G. Wesley, MPH; Julie Mayo Lamberte, MSPH; Xiaoxiao Sun, PhD; Michael E. Smith; Andrew L. Phillips, MD; Kimberly D. Groover, PhD; Young M. Yoo, MSPH; Joe Gerald, MD; Rachel T. Brown, PhD; Meghan K. Herring, MPH; Gregory Joseph, MPH; Shawn Beitel, MSc; Tyler C. Morrill, MS; Josephine Mak, MPH; Patrick Rivers, MPP; Katherine M. Harris, PhD; Danielle R. Hunt, PhD; Melissa L. Arvay, PhD; Preeta Kutty, MD; Alicia M. Fry, MD; Manjusha Gaglani, MBBS, MMWR, CDC

Under real-world conditions, mRNA vaccine effectiveness of full immunization (≥14 days after second dose) was 90% against SARS-CoV-2 infections regardless of symptom status; vaccine effectiveness of partial immunization (≥14 days after first dose but before second dose) was 80%.

3/29/2021   How mRNA Technology Could Change the World, by Derek Thompson, The Atlantic

More than 40 years had passed between the 1970s, when a Hungarian scientist pioneered early mRNA research, and the day the first authorized mRNA vaccine was administered in the United States, on December 14, 2020. In the interim, the idea’s long road to viability nearly destroyed several careers and almost bankrupted several companies.

3/29/2021   Scientists figured out the Moderna COVID-19 vaccine's code and posted it on Github, by Matt Binder, Mashable

As Motherboard mentions, COVID-19 vaccines have been reverse-engineered before. In late 2020, the founder of PowerDNS, an open source software provider, was able to figure out the mRNA sequence of the BioNTech/Pfizer vaccine using only information that was available online.

3/29/2021   Stanford Scientists Reverse Engineer Moderna Vaccine, Post Code on Github, by Matthew Gault, Motherboard

The Pfizer/BioNTech data [Figure 1] verified the reported sequence for that vaccine
(https://berthub.eu/articles/posts/reverse-engineering-source-code-of-the-biontech-pfizer-vaccine/), while
the Moderna sequence [Figure 2] could not be checked against a published reference.

3/23/2021  Assemblies-of-putative-SARS-CoV2-spike-encoding-mRNA-sequences-for-vaccines-BNT-162b2-and-mRNA-1273, GitHub

by 

  • Dae Eun Jeong,
  • Matthew McCoy,
  • Karen Artiles,
  • Orkan Ilbay,
  • Andrew Fire*,
  • Kari Nadeau,
  • Helen Park,
  • Brooke Betts,
  • Scott Boyd,
  • Ramona Hoh, and
  • Massa Shoura*, 

Departments of Pathology, Genetics, Pediatrics, and Medicine, Stanford University School of Medicine and Veterans Affairs Palo Alto Medical Center, Github

Moderna mRNA 1273

 

BioNTech Pfizer BNT 162b2

 

 

3/25/2021   12 people are behind most of the anti-vaxxer disinformation you see on social media, by Matt Binder, Mashable

Health misinformation was a huge problem in 2020 amid the ongoing COVID-19 pandemic. According to the Center for Countering Digital Hate, more than 59 million people were reached on social media platforms at the end of last year by the 425 anti-vaxxer accounts which the organization tracks. 

3/22/2021   Israeli company claims oral COVID-19 vaccine on its way, By MAAYAN JAFFE-HOFFMAN, The Jerusalem Post

Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company based on technology developed by Hadassah-University Medical Center, announced over the weekend a joint venture with India-based Premas Biotech to develop a novel oral vaccine. Together they formed the company Oravax Medical Inc. The vaccine is based on Oramed’s “POD” oral delivery technology and Premas’s vaccine technology.

The new Oravax vaccine candidate targets three structural proteins of the novel coronavirus, as opposed to the single spike protein targeted via the Moderna and Pfizer vaccines, Kidron said. As such, this vaccine should be much more resistant to COVID-19 variants.

 

Oramed’s technology can be used to orally administer a number of protein-based therapies, which would otherwise be delivered by injection. Oramed is in the midst of a Phase III clinical trial through the US Food and Drug Administration of an oral insulin capsule for Type 1 and Type 2 diabetes.

3/18/2021   Understanding and Explaining mRNA COVID-19 Vaccines, CDC

Beyond vaccines, numerous preclinical and clinical studies have used mRNA to encode cancer antigens to stimulate immune responses targeted at clearing or reducing malignant tumors.

3/16/2021   The Disinformation Dozen, Center for Countering Digital Hate

Tracking of 425 anti-vaccine accounts by CCDH shows that their total following across platforms now stands at 59.2 million as a result of these failures.

 

The 20 anti-vaxxers with the largest followings account for over two-thirds of this total.

The Disinformation Dozen account for up to 73% of Facebook’s anti-vaxx content.

 

TweetOfDrToshnerReClotting 2021 03 16

Threadreader version, rolled up and readable in a browser

3/16/2021

TweetOfVaccine 2pt2PctMortality

 

 

3/15/2021   As Biden Confronts Vaccine Hesitancy, Republicans Are a Particular Challenge, by Annie Karni and Zolan Kanno-Youngs, The New York Times

While there are degrees of opposition to vaccination for the coronavirus among a number of groups, including African-Americans and antivaccine activists, polling suggests that opinions in this case are breaking substantially along partisan lines.

 

A third of Republicans said in a CBS News poll that they would not be vaccinated — compared with 10 percent of Democrats — and another 20 percent of Republicans said they were unsure.

 

Widespread opposition to vaccination, if not overcome, could slow the United States from reaching the point where the virus can no longer spread easily, setting back efforts to get the economy humming again and people back to a more normal life.

 

But many conservative and rural voters continue to point to a variety of worries. Some conservatives harbor religious concerns about the Johnson & Johnson vaccine, which uses abortion-derived fetal cell lines.

3/5/2021   Americans are increasingly willing to get vaccinated, according to a new survey, by Ruth Graham, The New York Times

The proportion of adults in the country who intend to get vaccinated has increased significantly over the last several months, according to a survey released Friday by the Pew Research Center. Sixty-nine percent of the public now plans to get vaccinated — or already has — up from 60 percent who said in November that they intended to pursue it.

 

The issue has become more partisan over time, however. The new survey finds a 27-percentage point political gap, with 83 percent of Democrats saying they plan to get the vaccine or have already received it, compared to just 56 percent of Republicans.

2/8/2021   A Few Covid Vaccine Recipients Developed a Rare Blood Disorder, by Denise Grady, The New York Times

One day after receiving her first dose of Moderna’s Covid vaccine, Luz Legaspi, 72, woke up with bruises on her arms and legs, and blisters that bled inside her mouth.  Ms. Legaspi was strong and in good health before receiving the Moderna vaccine. But when she was admitted to the city hospital in Elmhurst, Queens, her platelet count was zero. Normal readings range from 150,000 to 450,000, and anything under 10,000 is considered very dangerous and in urgent need of treatment.  It is not known whether this blood disorder is related to the Covid vaccines.

1/10/2021   Exploring the Supply Chain of the Pfizer/BioNTech and Moderna COVID-19 vaccines, by Jonas Neubert

I’ll start with the bad news: Nobody will be making an mRNA vaccine in their garage any time soon.

 

Both Pfizer-BioNTech and Moderna each have two largely independent supply chains in Europe and the United States. This makes sense in order to maximize utilization of available manufacturing capacity and to add resilience through redundancy. Bloomberg’s Supply Lines newsletter points out that it also appeases certain “protectionist governments intent on hobbling international cooperation by exerting sovereignty over supply chains”. In fact, “America exports virtually nothing out of its borders” (says German chancellor Merkel)12 and supply agreements with manufacturers specifically prohibit sending vaccine from Europe to the US, for example Moderna’s contract with Lonza.

 

Following the active ingredient from beginning (DNA synthesis) to end (fill-and-finish into vials) takes on the order of weeks. For example, Moderna’s first ever batch of the COVID-19 vaccine was sent off to the National Institutes of Health (NIH) for phase 1 clinical trials 42 days after the design of the vaccine was completed.14 (The final 14 of those 42 days were spent waiting for the fixed-length sterility test experiment to complete.)

 

A note about the relationship between BioNTech and Pfizer: BioNTech is the original developer of several COVID-19 vaccine candidates. In March 2020, BioNTech announced a collaboration with Pfizer that involves jointly pursuing clinical trials for the candidates, development of the final vaccine, and all other remaining steps towards global distribution including manufacturing, distribution, finances, and marketing.15 Pfizer owns marketing and distribution rights for all but three countries in the world.16 Those three exceptions are: Germany and Turkey where BioNTech themselves markets and distributes, and China where Shanghai Fosun Pharma holds the marketing rights.17 Pfizer and BioNTech share gross profits generated outside of China 50:50.

 

Fun fact: BioNTech’s headquarter’s street address is “An der Goldgrube 12” which literally translates to “At the Goldmine 12”.

 

 12/27/2020   

TweetOfBertHubert ReverseEngineeringBioNTechVaccine 2020 12 27

 

 

The BNT162b2 mRNA vaccine has this digital code at its heart. It is 4284 characters long, so it would fit in a bunch of tweets. At the very beginning of the vaccine production process, someone uploaded this code to a DNA printer (yes), which then converted the bytes on disk to actual DNA molecules.

 

A Codex DNA BioXp 3200 DNA printer

The Codex DNA BioXp 3200 DNA printer

 

 

12/19/2021   Moderna's groundbreaking coronavirus vaccine was designed in just 2 days, by Susie Neilson, Andrew Dunn and Aria Bendix, Business Insider

 

11/17/2020   A vial, a vaccine and hopes for slowing a pandemic — how a shot comes to be, by Carolyn Y. Johnson, The Washington Post

“There’s a lot of times in this industry, you work on something that you know someone — a family member or friend” affected by a disease, said Pamela Siwik, vice president of Pfizer Global Supply. “In this case, it’s the world.”

2/4/2020   The promise of mRNA vaccines: a biotech and industrial perspective, by Nicholas A. C. Jackson, Kent E. Kester, Danilo Casimiro, Sanjay Gurunathan & Frank DeRosa, NPJ/Vaccines

Assuming that mRNA vaccines will be proven clinically efficacious and safe, one of the central advantages hinges on rapidity of manufacture. Within weeks, clinical batches can be generated after the availability of a sequence encoding the immunogen. The process is cell-free and scalable. Of paramount advantage, a facility dedicated to mRNA production should be able to rapidly manufacture vaccines against multiple targets, with minimal adaptation to processes and formulation. In addition, new targets requiring multi-antigen approaches will benefit from the speed in which mRNA can render multiple constructs.

 

SchematicOfmRNAVaccinesMechanismOfAntigenExpression

4/10/2019   mRNA as a Transformative Technology for Vaccine Development to Control Infectious Diseases, by Giulietta Maruggi, Cuiling Zhang, Junwei Li, Jeffrey B. Ulmer, and Dong Yu1, NIH US National Library of Medicine

Due to the ability of the host’s innate system to sense and respond to RNA sequences of viral origin (reviewed in Chen et al.9 and Vabret et al.22), mRNA vaccines induce robust innate responses, including production of chemokines and cytokines such as interleukin-12 (IL-12) and tumor necrosis factor (TNF) at the injection site.23, 24, 25 These are factors crucial to successful induction of effective adaptive responses against the encoded antigen.26 Currently, two forms of mRNA vaccines have been developed: conventional mRNA encoding the antigen of interest flanked by 5′ and 3′ UTRs, and self-amplifying mRNA derived from the genome of positive-stranded RNA viruses. Self-amplifying mRNA encodes not only the antigen but also the viral replication machinery required for intracellular RNA amplification leading to high levels of antigen expression (Figure 1). Unique attributes of each mRNA technology, as well as the roadblocks that need to be overcome for advancement, are summarized in Table 1.

 

1/12/2018   mRNA vaccines — a new era in vaccinology, by Norbert Pardi, Michael J. Hogan, Frederick W. Porter & Drew Weissman, Nature Reviews/Drug Discovery

 

4/18/2011   The Vaccine Safety Datalink: a model for monitoring immunization safety, National Library of Medicine