BNT162a1 / Pfizer, BioNTech, Fosun Pharma - LARVOL DELTA

A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-19 in Healthy and Immunocompromised Adults (clinicaltrials.gov) - P1/2 | N=512 | Completed | Sponsor: BioNTech SE | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-2019 in Healthy and Immunocompromised Adults (clinicaltrials.gov) - P1/2; N=512; Active, not recruiting; Sponsor: BioNTech SE; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

Pfizer and BioNTech announce further details on collaboration to accelerate global Covid-19 vaccine development (GlobeNewswire) - "The two companies plan to jointly conduct clinical trials for the COVID-19 vaccine candidates initially in the United States and Europe across multiple sites. BioNTech and Pfizer intend to initiate the first clinical trials as early as the end of April 2020, assuming regulatory clearance."

New trial • Infectious Disease • Novel Coronavirus Disease

mRNA Takes Center Stage in COVID-19 Vaccine and Cancer Research (Dana-Farber Cancer Institute) - "Unlike mRNA vaccines for COVID-19, mRNA vaccines for cancer are meant to treat the disease, not prevent it. Beyond that, however, they're based on the same principle: use mRNA molecules to trigger the production of proteins that rouse the immune system to attack a foreign invader such as the coronavirus, or an abnormal cell such as a tumor cell....Toni Choueiri, MD...is leading the first clinical trial of NeoVax in patients with kidney cancer."

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Moderna COVID-19 Vaccine Side Effects: How Long They Last (Healthline) - "'As the vaccine works to 'train' your immune system to start developing antibodies, the pain is a sign of the inflammation that occurs as part of this process,' said Dr. Shobha Swaminathan....'Since that is the first exposure, reactions tend to be mild,' Swaminathan said....'Since the patients have already 'seen' the vaccine from the first shot, the second booster is an exaggerated response to the same,' Swaminathan said....'Since Moderna and Pfizer require two shots and most side effects were from the second shot, the J&J vaccine may have slightly fewer side effects,' said Swaminathan."

Media quote • Novel Coronavirus Disease

Why Vaccinated People Are Not Exempt From Mask Mandates (The Observer) - "In an interview with The New York Times, Dr. Yvonne Maldonado, who represents the American Academy of Pediatrics at meetings of the Federal Advisory Committee on Immunization Practices, noted the danger of vaccinated people still being able to spread the virus. 'Vaccinated people who have a high viral load but don't have symptoms would actually be, in some ways, even worse spreaders because they may be under a false sense of security,' Maldonado said."

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Fauci: Vaccines for Kids as Young as First Graders Could Be Authorized by September (ProPublica) - "'That's not what we see with COVID'. But exactly how infectious children are remains somewhat unclear, in part because schools have not been fully open, making it hard to gather data, said Dr. Yvonne Maldonado...Studies from other countries, while informative, may not always extrapolate well to the U.S., she added."

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When Will Kids Receive Covid Vaccinations? (Daily Nurse) - "'The longer we take to start kids in trials, the longer it will take them to get vaccinated and to break the chains of transmission,' said Dr. Yvonne Maldonado...who chairs the AAP's infectious disease committee. 'If you want kids to go back to school and not have the teachers union terrified, you have to make sure they aren't a risk.'"

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D.C. Vaccine Progress: Nearly Ten Percent At Least Partially Vaccinated and New Registration System Coming (Washington City Paper) - "'When we look at inventory, we do find doses that haven’t moved mainly in our hospitals,' Shah said. He estimates roughly 4,000 to 5,000 doses weren't moving due to weather delays and logistical obstacles....'I don't think we'll ever get to a point where we are above 80 percent, especially as we are confirming everybody who’s had a first dose has a second dose waiting for them,' Shah told the Council."

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Scientists Are Optimistic That the Vaccine Will Partially Prevent Infection (Elemental by Medium) - "'When you give individuals the polio vaccine, they can get infected [with the virus], but they don't get paralyzed, they don't get sick,' Maldonado says. 'But they can serve as a source of infectious virus to other people'....'I think we message that these vaccines are extraordinary, but we don't know yet what the limitations are, and we just need to wait a little bit longer,' concludes Maldonado. 'I'm not saying we should shut down. I do think we should be opening up economies. I just think taking off the masks is not a good idea right now.'"

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CDC Panel Recommends Pfizer's COVID-19 Vaccine for People 16 and Over (Medscape) - "Yvonne Maldonado, MD, the American Academy of Pediatrics representative on the panel, said that this age group should not be denied the vaccine as they often have essential or front-line jobs that put them at higher risk for infection. 'I am very concerned about this message being sent out that this vaccine will not be safe in children,' said Maldonado....'We currently have no evidence that that is the case,' she said, adding there is also no indication younger children are biologically or physiologically different in their response or safety risk than 18-year-olds."

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Nurse tests positive for COVID-19 week after getting vaccine; experts remind shot needs time to work (Fox23 News) - "It's a sad coincidence that if somebody has already been exposed and gotten vaccinated, the vaccine doesn't work within days. I mean it does work within days but certainly not in less than a week,' Dr. Yvonne Maldonado told KGO."

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Stanford vaccine expert: ’They do look very safe’ (Palo Alto Online) - "Maldonado said that while the nation's current allocation of 100 million doses of the vaccines might seem plentiful, 'We do not think that is enough'....'The supply chain might be an issue,' she said....At Stanford, many of Maldonado's colleagues are excited about the vaccines. They think the vaccines are 'an opportunity to really stem this pandemic,' she said."

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Will Kids Get A COVID-19 Vaccine? Pfizer To Expand Trial To Ages 12 And Up (GPB News) - "'Children have not been the main focus at this point because of the rush to get these trials going in adults,' says infectious disease expert Yvonne Maldonado....'For almost any other vaccine trial, you're almost always going to start in adults anyway to find if there's a safety signal in the adult population before you move into the pediatric population,' Maldonado explains...'With all of the proper precautions in place and sufficient safety data from adult studies, progressing to trials in older children would be important,' she says."

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What Are The Side Effects Of The Coronavirus Vaccine? (HuffPost Wellness) - "The Pfizer and Moderna vaccine candidates both require two doses, meaning you'll need two shots over a short period of time to be protected. In both of their trials, there seemed to be more of a reaction after the second dose, but side effects remained mild to moderate in about 90% to 95% of cases, Maldonado said. 'Most vaccines will have some degree of minor side effects. It is, in fact, the body's immune and inflammatory response to the vaccine,' which is supposed to happen, Maldonado said."

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California Hospitals Blame Poor Vaccine Rollout on Lack of Transparency From Government (Newsweek) - "'Nobody was prepared for a pandemic, but we did know a vaccine was coming,' Maldonado told Newsweek last Friday. 'We've been working on this vaccine since March or April, but at the same time nobody knew how the federal government would direct the implementation of vaccination'....'People who know how to work the internet, who speak English, who have a health care provider - those people are going to get it first,' Maldonado said. 'We need to address that. We know who's being affected by this pandemic, and it's generally not those people.'"

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'Help is on the way': How the U.S. will turn the tide of the pandemic in 2021 (NBC News) - "Dr. Yvonne Maldonado...said, 'We're going to have to adapt to Covid for at least the next year.' That includes treating masks and social distancing like other safety precautions. 'We are so accustomed to stopping at a red light, even when it's the middle of the night and there's nobody in the street,' Maldonado said. 'Why do we do that? Because we recognize it's a societal good'. 'Thank God we've come to that point where we recognize as a society that things need to be done in order to save all of us.'"

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COVID Vaccines: California Health Care Experts Plan for Distribution of COVID-19 Vaccine When Available (CBS SF Bay Area) - "'If it happens on Thanksgiving Day, it happens on Thanksgiving Day but we'll be ready to go'...Dr. Yvonne Maldonado....'Our committee is charged with reviewing the safety of the vaccine,' explained Dr. Maldonado....'After the CDC gets it...we will have an emergency meeting. At the same time or within hours...we will have that information available to the state,' said the vaccine expert."

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Study suggests link between COVID-19, blood group A and ‘ancient’ protein family (Healio) - "'Blood group antigens were the first polymorphic structures ever described in the human population, and so we've known about them for a really long time,' Sean R. Stowell, MD, PhD...said in an interview with Healio. 'We're still trying to figure this out, but it's amazing to me that blood group antigens might be influencing this huge pandemic, and that they may be doing so through this really ancient carbohydrate-binding protein that viruses share with us. Whether or not blood group proves to be associated with COVID-19, there's something going on there that's intriguing.'"

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7 COVID-19 Vaccine Myths, Debunked by Experts (Health.com) - "There's also this to consider: 'The vaccine can be lifesaving,' Shobha Swaminathan, MD...clinical research site leader for the Moderna COVID-19 vaccine trial, tells Health....Dr. Swaminathan stresses that there is 'absolutely no evidence whatsoever' to support the claims that the vaccines cause infertility. 'Just because you say something loudly doesn't it true,' she says. 'The vaccines do no impact the fertility system'....'It's true that we've never created a vaccine on a shorter timeline,' Dr. Swaminathan says. 'But the vaccines went through the same rigorous processes as other vaccines. Everything just fell into place perfectly.'"

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COVID-19 vaccines for children and teens are coming, experts say (Los Angeles Times) - "'That's how we do all vaccine trials,' Maldonado said. 'We always start with adults and then we work into children'....'Sometimes children respond the same to vaccines as adults do but sometimes they don't,' Maldonado said. 'It's very different for each organism, each type of disease, each vaccine - so there's no one answer to that question, and that's why you have to do a trial each time.'"

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Shots Heard 'Round the World: Will Pfizer, Moderna Vaccines Start End of Pandemic? (The Street) - "'We know that children can be infected with Covid-19 and can transmit it to others. To reduce the spread of this virus and control the pandemic as well as for their own safety, it's crucial that children be included in the national vaccination program, and that vaccines are made available to children as soon as possible,' said Dr. Yvonne Maldonado, chair of the American Academy of Pediatrics committee on infectious diseases, in a press statement last week."

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When Will a COVID-19 Vaccine Be Safe for Pregnant Women? (Verywell Family) - "Dr. Maldonado agrees. 'We believe that pregnant women, who make up a large share of the healthcare workforce and the general population, should be protected against infection with SARs-CoV-2 with a vaccine that has been shown to be safe and effective for them.'"

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California’s Chaotic COVID Vaccine Rollout Lurches Forward (CBS SF Bay Area) - "'The process is not as simple as we think it is,' said...Dr. Bonnie Maldonado. 'It's not just a matter of coming to existing clinics. We're layering on a brand new vaccine with brand new instructions'....'Billions of dollars were spent on developing these vaccines,' she says. 'Billions of dollars were not spent on implementing vaccine administration rollout so counties and states have been doing vaccination programs with almost no additional resources.'"

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Panelists tackle COVID-19 unknowns, urge pediatric clinical trial participation (AAP News) - "Federal leaders have commented that pediatric clinical studies may not involve tens of thousands of participants but instead use immune bridging, Dr. Maldonado said. 'The antibody that's elicited in children is that similar to what we see in antibody in adults. That could potentially speed up the process of pediatric trials a bit, but (children) are going to lag behind'. 'There have not been any signals so far (from data presented during FDA and CDC Advisory Committee on Immunization Practices meetings), but we want to make sure that we know whether there might be any risk of that occurring,' she said."

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