The United States government will fund and conduct studies on three different coronavirus vaccines, according to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

The coronavirus vaccine effort is progressing very well and we expect more than one candidate vaccine to be in advanced clinical testing by early summer…This is good news for the overall coronavirus vaccine effort.”

Dr. Fauci, CNN

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Phase 3 trials for Moderna’s experimental vaccine will begin in July. Oxford/Astra Zeneca will be tested in August, and Johnson & Johnson will follow with their vaccine trials in September. The trials will begin after companies have enough safety and efficacy information from earlier phases. Phase 3 will take place at more than 50 sites throughout the U.S. and could involve about 30,000 people.

According to the New York Times coronavirus tracker, there are ten vaccines in phase 1, eight in phase 2, and two vaccines in phase 3. Oxford/AstraZeneca is in phase 2/3 in England and Brazil, and the company could potentially deliver emergency vaccines by October.

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Forty-three thousand pounds of raw beef produced by Lakeside Refrigerated Services in New Jersey was recalled due to E.coli contamination. The beef was produced on June 1 and sold at Wal-mart. The United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) announced the recall on Saturday.

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FSIS is concerned that some product may be in consumers’ refrigerators or freezers…Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.”

Food Safety and Inspection Service

The beef tested positive for E. coli O157: H7, a strain of E.coli that is responsible for 36% of the more than 265,000 STEC (Shiga toxin-producing E. coli) infections in the U.S. every year. The FSIS found the bacteria through routine testing and has not confirmed any adverse reactions to the contaminated beef.

The USDA recalled almost 700,000 pounds of beef in 2019. Previous years saw recalls of 13 million (2018) and 900,000 (2017) pounds of beef. In another year this recall would not be a big deal. However, the meat processing industry is still reeling from coronavirus and labor processing, and it is unclear how recalls will affect the food supply chain in 2020.

Sources:

• Over 40,000 pounds of ground beef recalled due to E. coli concerns – KSL
• Summary of Recall Cases in Calendar Year 2019 – USDA

The Food and Drug Administration has announced that it will allow certain impurities in alcohol-based sanitizers to meet the public health demands during the COVID-19 pandemic. The relaxed guidelines will directly affect fuel ethanol companies that began making sanitizer at the beginning of the pandemic.

The FDA is working with industry to ensure that harmful levels of impurities are not present if ethanol is used in these products. Based on careful review and consideration of available data, we are specifying interim levels of certain impurities that we have determined can be tolerated for a relatively short period of time, given the emphasis on hand hygiene during the COVID-19 public health emergency and to avoid exacerbating access issues for alcohol-based hand sanitizer.”

FDA

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This announcement is in direct contrast to the agency’s position in April, when it told several fuel ethanol companies that their sanitizers didn’t meet safety standards. Two ingredients under particular scrutiny are acetaldehyde, a carcinogen, and benzene.

Sources:

• U.S. temporarily to allow certain impurities in hand sanitizer – Reuters
• U.S. calls ingredients in some ethanol-based hand sanitizers unsafe – Reuters

Gardasil 9, the latest version of the well-known human papillomavirus virus vaccine, has been approved by the Food and Drug Administration (FDA) for the prevention of HPV related throat and neck cancers. The FDA gave the drug an accelerated approval, which means their decision is dependent on more information. Merck started a study to see if Gardisil treats these cancers in February.

The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The trial is currently underway.

Merck Press Release

The trial is focused on men after researchers noticed that certain throat cancers linked to HPV were most common in middle-aged men who had contracted the virus decades earlier. Other throat cancer risks include smoking cigarettes and performing oral sex on partners with HPV.

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Introduced in 2006, Gardisil was marketed to young women and girls aged 9 to 26. Those recommendations expanded to include men and to the age of 45 in 2018 with the introduction of Gardisil 9. Demand for Gardisil has continued to increase worldwide since its introduction, with total vaccine sales reaching 3.15 billion in 2018.

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Sources:

• FDA approves Gardasil 9, the HPV vaccine, to prevent head-and-neck cancer – Statnews
• FDA Approves HPV Vaccine to Prevent Throat Cancer – Labroots
• Unprecedented global demand for Gardasil 9 – Pharmaceutical Technology

The Environmental Protection Agency (EPA) has decided to allow farmers who purchased dicamba-based products to use them this year, despite a June 3rd ruling by the Ninth Circuit Court of Appeals that canceled the product’s approval. Bayer’s XtendiMax, BASF’s Engenia, and Corteva Agriscience’s FeXapan can now be used in specific circumstances after the EPA received feedback from farmers who had already purchased the herbicides.

At the height of the growing season, the Court’s decision has threatened the livelihood of our nation’s farmers and the global food supply…Today’s cancellation and existing stocks order is consistent with EPA’s standard practice following registration invalidation, and is designed to advance compliance, ensure regulatory certainty, and to prevent the misuse of existing stocks.”

Andrew Wheeler, EPA Administrator

According to the order, distribution or sale of the dicamba-based herbicides are still prohibited unless for proper disposal or returns. Those who purchased the herbicides before the June 3rd cancellation are still able to use them. All of use of these systems must cease by July 31st.

The Center for Food Safety and the Center for Biological Diversity (CBD) have already filed a motion asking the Ninth Circuit Court to hold Wheeler and the EPA in contempt for allowing farmers to use the product in defiance of the court’s decision.

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It’s mind-boggling to see the EPA blatantly ignore a court ruling, especially one that provides such important protections for farmers and the environment…We’re asking this court to restore the rule of law at the Trump EPA.”

Stephanie Parent, a senior attorney with the Center for Biological Diversity

New Jersey has become the first state to mandate climate change education in its kindergarten through 12th-grade curriculum. The state will implement that requirement in September of 2021. New Jersey First Lady Tammy Murphy partnered with 130 educators and led the push to incorporate climate change into the state’s education standards.

The adoption of these standards is much more than an added educational requirement; it is a symbol of a partnership between generations…Decades of short-sighted decision-making has fueled this crisis and now we must do all we can to help our children solve it. This generation of students will feel the effects of climate change more than any other, and it is critical that every student is provided an opportunity to study and understand the climate crisis through a comprehensive, interdisciplinary lens.”

Tammy Murphy, First Lady of New Jersey

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Climate change education is woefully unaddressed in the United States. Despite the effects climate change has on people worldwide, a 2019 NPR/Ipsos poll found that only 42% of teachers are teaching climate change. The demand is there, with 4 in 5 teachers and parents saying that students need to be taught this information. Climate change is here and continuing to escalate. States will do their students a grave disservice if they fail to adequately confront this issue.

Sources:

• New Jersey Is Now the 1st US State to Require Schools to Teach Climate Change – Global Citizen
• Most Teachers Don’t Teach Climate Change; 4 In 5 Parents Wish They Did – NPR

President Trump has opened the only national marine monument in the Atlantic to commercial fishing. The Northeast Canyons and Seamounts Marine National Monument was established in 2016 by President Obama and includes nearly 5,000 acres of the coast of New England. The monument is noted for its biodiversity, and opening up the area to commercial fishing will have a devastating effect on that ecosystem.

Opening up the nation’s only marine national monument in the Atlantic will help no one but a handful of fishers while risking irreparable damage to the marine wildlife that have no other fully protected areas off our eastern seaboard…Ancient and slow-growing deep sea corals, endangered large whales and sea turtles, and an incredible array of fish, seabirds, sharks, dolphins, and other wildlife—these are the species and habitats that will pay the price.”

Bob Dreher, senior vice president of Conservation Programs at Defenders of Wildlife

The area is home to four seamounts, 3 underwater canyons, more than 54 species of deep-sea corals, and is a frequent feeding ground for whales, sharks, seabirds, dolphins, turtles, and other species. Many of the corals are more than 1,000 years old.

President Trump’s decision comes a day after he signed an executive order removing the need for environmental review before going forward with projects like pipelines and highways. The opening of the Northeast Canyons and Seamounts Marine National Monument to commercial fishing, leaving more than 1,000 species open to the damage caused by the industry, is only the latest of the President’s systemic dismantling of environmental protections in the United States.

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Sources:

• Trump Illegally Eliminates Protections for First and Only Monument in the Atlantic Ocean – NRDC
• Northeast Canyons and Seamounts Marine National Monument – NOAA Fisheries