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Following Very Promising Animal Tests, New Human Data Shows Pfizer Vaccine More Than 90% Effective

Early data released today by Pfizer suggests their vaccine candidate is more than 90% effective in preventing against coronavirus infection. The vaccine is being developed in collaboration with German drugmaker BioNTech. Pfizer says their analysis showed the vaccine was able to prevent COVID-19 in the vast majority of volunteers who had no evidence of prior infection. 

The vaccine candidate underwent preclinical tests in mice and nonhuman primates. Those studies showed it produced “strong anti-viral effects.” 

While additional human studies are required, if the most recent data holds up, the candidate would be on par with highly effective vaccines for other diseases such as measles. In addition, the company says no safety concerns have yet been observed. 

More information from the New York Times: Pfizer Stuns Experts With Early Data that Vaccine Is More Than 90% Effective

More information from Pfizer: Pfizer press release  

Several Significant COVID-19 Developments 

Tuesday marked a day with several major COVID-19 events: 

  • Another vaccine trial has been placed on hold. Johnson & Johnson’s study was paused due to unexplained illness in a participant. That vaccine candidate is in the midst of a 60,000-patient clinical trial. 
  • The first United States resident confirmed to be reinfected with the coronavirus is a 25-year-old Nevada man. His second infection was considered “more severe“ than the first. However, the man fully recovered both times. This is the fifth documented case of its kind worldwide.
  • Finally, the National Institute of Allergy and Infectious Diseases today launched a study designed to determine whether certain approved therapies or investigational drugs in late-stage clinical development show promise against COVID-19. The ACTIV-5 Big Effect Trial will enroll adult volunteers hospitalized with COVID-19 at several sites. More information on that initiative can be found here. 

Primate Researchers Urge Additional COVID-19 Vaccine Studies in Monkeys to Determine the Safest and Most Effective Candidates

According to an article published online today by Science Magazine, primate researchers based in the U.S. are pushing for head-to-head COVID-19 vaccine candidate studies in monkeys. The scientists believe human clinical trials may not deliver the comprehensive data needed to choose the safest and most effective vaccines. They say the research could be done within weeks.

“We should take a cold, hard look at all of the data and ask ourselves, ‘What appears to work best?’” said Nancy Haigwood, Director of the Oregon National Primate Research Center at Oregon Health & Science University.   

Dr. Haigwood and her colleagues at the six other national primate research centers are now turning to the National Institutes of Health (NIH) for support.

The full Science article can be found at this link.

AMP Takes to the Airwaves to Discuss the Importance of Animal-Based Research to Combat COVID-19, Other Diseases

AMP Executive Director Paula Clifford and Communications Director Jim Newman were guests this week on Federal News Network Radio, a Washington, D.C.-based radio station and news agency. They spoke with host Tom Temin about the continued need for animal studies and how research animals are treated with kindness and respect.

Paula and Jim also discussed the importance of research taking place at the Department of Veterans Affairs, an agency which has been targeted by animal rights groups in recent months. 

The full interview is posted online and can be found at this link.

COVID-19 Death Toll Officially Surpasses 200K

The U.S. death toll from the coronavirus pandemic officially passed 200,000 on Tuesday. The grim milestone comes on the first day of fall and brings with it quite a few concerns. Caseloads are once again growing in several states including Wisconsin, Montana and North Dakota. There are also worries about the arrival of flu season and the likelihood that cooler temperatures will result in larger numbers of people congregating indoors. 

In additional news, the availability of a COVID-19 vaccine for children may not arrive until fall 2021. Experts say this is the case because no trials have yet begun in the United States to determine whether the vaccines developed to date are safe and effective for children.


Why Animal Studies Are Necessary for Creating Kid-Safe Vaccines

As an article in the journal Current Biology explained earlier this week, the COVID-19 pandemic is repeatedly demonstrating the vital need for animal studies. Today, Wired Magazine provided additional proof in a story titled “Making a COVID-19 Vaccine Is Hard. Making One for Kids Is Harder.“ Writer Gregory Barber explains how monkeys at the California National Primate Research Center are providing critical information to help us understand how COVID-19 vaccines will impact children. 

Here’s an excerpt: 

For those feeling lost in this time-bending pandemic summer, consider this frame of reference: the birthing season of the rhesus macaque. At the California National Primate Research Center, the first infants of the year arrived in February, just as the virus took hold in the surrounding area. The births continued through the spring, during which the virus surged and adult monkeys became a key model to plumb how humans might respond to the virus and vaccines. The last infants of the season showed up a few weeks ago. Among those stragglers, 16 were selected for an experiment: an inoculation with one of two Covid-19 vaccine candidates currently in late-stage clinical trials. It’s a first step toward answering a question that’s received little attention in that warp-speed, all-hands-on-deck effort: how children will respond to a Covid-19 vaccine.   

The full article can be found at this link.


New Journal Article: COVID-19 Has Demonstrated the Necessity of Animal Research

A newly published article in the Cell Press journal Current Biology examines how the novel coronavirus pandemic has demonstrated the continued need for animal studies. The paper was penned by researches at several institutions across The Netherlands and Germany. As the authors explain, the only way the current crisis can be solved is through the development of vaccines and/or antiviral and adjunctive drug therapies. This requires biomedical research and specifically animal studies. 

The authors voice their support for non-animal alternatives. But at the same time they explain “currently there is no integrated replacement model to be able to completely replace animal research to study the complex functions of the body.“

The paper also includes several detailed examples of how animal models are aiding the fight against COVID-19:

  • The use of ferrets to investigate the transmission route of SARS- CoV-2.  
  • Lung pathology studies in nonhuman primates that help us understand how COVID-19 impacts the body. 
  • The paper authors highlight remdesivir, an antiviral drug developed and tested in animal models to treat Ebola infections. They go on to explain the drug was found to effectively reduce symptoms of SARS-CoV-2 infection in rhesus macaques. 

The article focuses at length on the importance of animals in vaccine efficacy and safety tests. This is a vital need illustrated by tests of a SARS-CoV-1 vaccine candidate in 2004 that alarmingly found some vaccinated ferrets developed hepatitis, rather than protection against the virus 

The full journal article can be found at this link.

Another Animal Study Provides Crucial Information in Effort to Rapidly Develop COVID-19 Vaccines

Animal studies have revealed additional encouraging data about the investigational vaccine being developed by the National Institute of Allergy and Infectious Diseases and Moderna. The candidate, named mRNA-1273, protected mice from infection with SARS-CoV-2, the virus that causes COVID-19. The research appears today in the journal Nature. Additional research collaborators were involved in the published study.  

The findings show the investigational vaccine induced neutralizing antibodies in mice when given two intramuscular injections of a 1-microgram (mcg) dose three weeks apart. Additional experiments found that mice given two injections of the 1-mcg dose and later challenged with SARS-CoV-2 virus either 5 or 13 weeks after the second injection were protected from viral replication in the lungs and nose. Importantly, mice challenged 7 weeks after only a single dose of 1 mcg or 10 mcg of mRNA-1273 were also protected against viral replication in the lungs. The investigational vaccine also induced robust CD8 T-cell responses in mice. It did not induce the type of cellular immune response that has been linked to vaccine-associated enhanced respiratory disease. 

Today’s news is just the latest in a series of animal studies that have provided helpful data in the development of COVID-19 vaccines. Research results released last week showed the same vaccine from NIAID/Moderna was able to quickly clear the infection from the lungs of nonhuman primates that were vaccinated and then exposed. Meanwhile, a separate vaccine being developed by Johnson & Johnson has been shown to protect monkeys from infection. 

The Nature preprint article mentioned above can be found at this link.

Link to National Institutes of Health press release containing additional details

T Cells May Offer Lasting COVID-19 Protection

A new study suggests memory T cells might protect some people infected with SARS-CoV-2 by remembering past encounters with other human coronaviruses. The finding might help explain why some people seem to fend off COVID-19 and may be less susceptible to becoming severely ill. 

To come to this conclusion, researchers obtained and analyzed blood samples from 36 people who’d recently recovered from mild to severe COVID-19. All these individuals produced T cells that recognize multiple parts of SARS-CoV-2. They then compared this data to people who’d survived SARS. Interestingly, those memory T cells, acquired in response to SARS-CoV-1, also recognized parts of SARS-CoV-2. 

Finally, the team looked at healthy individuals with no history of either COVID-19 or SARS. To their surprise, more than half had T cells that recognize one or more of the SARS-CoV-2 proteins being studied. It’s still not clear if this acquired immunity stemmed from previous infection with coronaviruses that cause the common cold or perhaps from exposure to other as-yet unknown coronaviruses.

Overall, the study makes clear that past experiences with coronavirus infections may have something important to tell us about COVID-19. 

The findings, were recently reported in the journal Nature.

Additional information can be found in this blog post by NIH director Dr. Francis Collins.

Clinical Trial Results for Moderna/NIH Vaccine Released in Preliminary Report

Late this afternoon, the National Institutes of Health announced preliminary phase 1 results of mRNA-1273, an investigational vaccine designed to protect against SARS-CoV-2, the virus that causes COVID-19. The vaccine candidate was one of the first to reach clinical trials. This was due in part to prior animal studies of related vaccines also developed collaboratively by NIH and Moderna Inc. 

According to the NIH, the vaccine was generally well tolerated and prompted neutralizing antibody activity in healthy adults. mRNA-1273 is designed to induce neutralizing antibodies directed at a portion of the coronavirus “spike” protein, which the virus uses to bind to and enter human cells. A Phase 2 clinical trial of mRNA-1273 began enrollment in late May. Plans are underway to launch a Phase 3 efficacy trial in July 2020. 

The preliminary report was published in the New England Journal of Medicine and can be found at this link.

Additional information can also be found in this NIH press release.