- In today’s Recommendations for Industry, we discuss how well the various COVID vaccines work against the variants. Read more below.
- The CDC estimates that, until now, about “60% of adults and 75% of children” have antibodies indicating that they’ve been infected with COVID-19 (CNN).
- Moderna has asked the FDA to authorize its vaccine for children under 6 years old (NYT). Similarly, the FDA has “laid out a tentative timetable” leading to June in which they may authorize the COVID-19 vaccine(s) for children (NYT).
- COVID cases around the world are fluctuating, yet again. In the U.S., a newer Omicron subvariant BA.2.12.1 “is responsible for 29% of new coronavirus infections as of mid-April, according to data from the Centers for Disease Control and Prevention. That’s up from 19% of cases the week prior and 14% of infections the first week in April” (US News). Although cases have risen, deaths have decreased by 20% over the past two weeks (CIDRAP). China’s battle with COVID-19, moving towards “zero-COVID” policy continues. Not only does the lockdown in Shanghai continue, cases in Beijing are rising and “authorities in Beijing imposed restrictions over the Labor Day 5-day holiday celebration, which is typically a busy travel season” (CIDRAP). As noted, South Africa’s COVID-19 test posivitity has also risen by 22% with another subvariant (BA.4 and BA.5); there is increasing concern that this is the start of its fifth COVID wave (CIDRAP/MarketWatch/The Guardian).
- Throughout the world, countries are lifting travel restrictions. In the most recent, Greece has officially removed all COVID-19 entry rules (Schengen Visa Info). Additionally, Italy has lifted its passenger locator form requirement; however, it has extended other COVID-19 entry measures (Schengen Visa Info).
- A recent publication in Nature Communications has found “Relative to the Pfizer/BioNTech COVID-19 vaccine, the Moderna version confers slightly more protection against infection—but not hospitalization, intensive care unit (ICU) admissions, or death—90 days after the second dose,” suggests a modeling study of more than 3.5 million fully vaccinated Americans published today in Nature Communications (CDIRAP).
- A new medication (CDC) to protect against COVID-19 has been allowed, Evusheld. One is eligible for Evusheld if:
- Are moderately or severely immunocompromised and may not mount an adequate immune response to COVID-19 vaccination OR have a history of severe allergic reactions to COVID-19 vaccines, and
- Do not currently have COVID-19 and have not recently had close contact with someone with COVID-19, and
- Are an adult or adolescent 12 years older weighing at least 88 pounds (40 kg)
- In the U.S., “seasonal influenza activity continues to increase in some areas of the country. The first human detection of avian influenza A(H5) in the United States was reported this week” (CDC). More on the first human U.S. avian flu case below.
- As we’ve discussed the increasingly deadly and widespread avian flu, nearly two-thirds of all American states have now seen affected flocks; confirmed in 23 states. To that end, CIDRAP reports, “In the wake of the recent announcement of the first human H5 avian flu case—involving a poultry culler in Colorado who had few symptoms—the CDC a few days ago issued a Health Alert Network notice that covered recommendations for human health investigations and response. The CDC said it’s impossible to determine if the H5 virus in the patient’s original respiratory sample was transient surface contamination of the man’s nasal passages or the result of an infection. The agency added that public health officials are pursuing the right approach by assuming that the man was infected and taking actions to contain and treat the virus.” (CIDRAP)
- Vaccinations are encouraged as the majority of influenza viruses detected are A(H3N2). H3N2 viruses identified so far this season are genetically closely related to the vaccine virus.
- Globally, flu cases continue; however, the majority of cases are from the Influenza A family type.
- Abbott will release its metabolic nutrition formulas “free of charge to patients, in coordination with healthcare professionals based on need and on a case-by-case basis. The lots being released were not included in the February recall and are now being released at the request of the U.S. FDA” (PR Newswire).
- FMI discusses the importance of “keeping food safety top of mind when sourcing produce grown indoors” (FMI).
- Raw milk is back on the platform with Georgia recently passing a bill driven by consumer demand. Food Safety News provides thoughts on this.
- Nigeria, Somalia, Yemen, Afghanistan, and Ethiopia have been confirmed as countries with largest measles outbreaks attributed to lack of vaccination.
- Hepatitis cases continue to remain dominant.
- As of 21 April 2022, at least 169 cases of acute hepatitis of unknown origin have been reported from 11 countries in the WHO European Region and one country in the WHO Region of the Americas. Cases have been reported in the United Kingdom of Great Britain and Northern Ireland (the United Kingdom) (114), Spain (13), Israel (12), the United States of America (9), Denmark (6), Ireland (<5), The Netherlands (4), Italy (4), Norway (2), France (2), Romania (1), and Belgium (1).
- The number of children with hepatitis of unknown etiology in the United Kingdom has increased to 145, with 34 cases reported in just the past 4 days. Cases may be associated with adenovirus infection, but because the symptoms of these childhood hepatitis cases are not typical of adenovirus infection, experts are still investigating other possible causes, such as new coronavirus infection or environmental factors.
- In the United States, there are least 25 cases: nine in Alabama, two in North Carolina, three in Illinois, four in Wisconsin, and seven in California. So far there has been one death in Wisconsin, and four of these children have needed liver transplants.
- A UK report suggesting that isolation of children through the pandemic may have weakened immune systems and made them more susceptible to hepatitis.
Recommendations for Industry
COVID Vaccine: How Effective Are They Against Variants?
COVID-19 Omicron variants continue to give rise to new cases, with CDC data showing BA.2.12.1 as being responsible for 29% of new coronavirus infections as of mid-April. While prior infection does provide some immunity, vaccines are still the best and most recommended way to reduce the risk of severe illness and hospitalization.
In follow up to last week’s article on the status of vaccines, this week’s article focuses on a recent comparison study by YaleMedicine of the five most prominent COVID-19 vaccines (only three of which are approved in the U.S.) and how well each works against variants:
- Pfizer Comirnaty (mRNA). Scientists are still learning about how effective the Pfizer-BioNTech vaccine is against Omicron, which is the predominant variant in the U.S. Early this year, the CDC published data that showed the mRNA booster shots provide significant protection against hospitalization from Omicron, and can reduce the risk of going to the emergency room or urgent care clinic. Additional data from the CDC in February suggested that mRNA booster effectiveness against hospitalization and visits to emergency room or urgent care centers wanes after about four months. Recent data from the CDC and a study (not yet peer-reviewed) from the New York State Health Department showed that protection from coronavirus infection in children 5- to 11-years old waned over time, although the vaccine continued to offer protection against hospitalization and death, even during the Omicron surge.
- Moderna Spikevax (mRNA). Scientists are still learning about how effective the Moderna vaccine is against Omicron. Early this year, the CDC published data that showed the mRNA booster shots provided significant protection against hospitalization from Omicron, and can reduce the risk of going to the emergency room or urgent care clinic. Additional data from the CDC in February suggested that mRNA booster effectiveness against hospitalization and visits to emergency room or urgent care centers wanes after about four months.
- Johnson & Johnson Janssen (carrier, or virus vector, vaccine). At the end of 2021, J&J announced that preliminary study results from South Africa showed a J&J booster to be 85% effective against hospitalization at a time when Omicron was the dominant variant in that country. More data on the vaccine’s effectiveness against Omicron is forthcoming.
- Novavax Nuvaxovid and Covovax (protein adjuvant). Not yet available in the U.S., but recently applied to the FDA for an EUA for its vaccine, which is already authorized for use in many other countries—most recently in Canada—and is shown to be highly effective in clinical trials. Novavax says its vaccine can generate an immune response against Omicron, but scientists are still learning about this. One study, from University of Oxford, showed Novavax to be an effective booster vaccine against the variant following the primary series of other vaccines.
- Oxford-AstraZeneca (carrier vaccine), Not available in the U.S., authorized for emergency use in other countries, including in the European Union (under the name Vaxzevria) and the United Kingdom. Scientists are still learning about how effective the vaccine is against the Omicron variant. Researchers in Israel are testing a fourth dose of this vaccine against Omicron.
In Case You Missed It:
- In last Thursday’s Recommendations for Industry, we discussed TAG’s weekly matrix and the “gentle swell” of COVID in the U.S. Read more here.
- CDC: 58% of Americans have had COVID-19. New COVID-19 seroprevalence data from CDC show that the Omicron surge infected a huge swath of Americans, with overall seroprevalence rising from 33.5% in December of 2021 to 57.7% in February 2022. The increase was seen most dramatically in children. In children ages 0 to 11, seroprevalence rose from 44.2% to 75.2%, and those 12 to 17, from 45.6% to 74.2%.
- Global COVID deaths drop to lowest since early pandemic months. Weekly COVID-19 deaths dropped to the lowest level since March 2020 and continue to drop, with just over 15,000 deaths reported to the WHO last week. However, because countries are reducing their testing, and the WHO is receiving less information on transmission and evolution, countries are urged to keep a close eye on cases and virus changes.
- FDA Approves First COVID-19 Treatment for Young Children. As discussed Tuesday, FDA expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include certain pediatric patients 28 days of age and older. Before now, Veklury was only approved to treat certain adults and pediatric patients 12 years and older with COVID-19.
- Moderna seeks U.S. authorization for COVID-19 vaccines for kids 5 and under. Moderna has requested FDA authorization for low doses of its COVID-19 vaccine for children younger than 6, submitting data for two low-dose shots. Currently, only children ages 5 or older can be vaccinated in the U.S., using Pfizer’s vaccine, leaving 18 million younger tots unprotected.
- COVID-19 pills to become more widely available in U.S. The Biden administration plans to expand access to free treatments to help patients avoid hospitalization and make it easier to get COVID-19 treatments. The plan is to double the 20,000 pharmacies, community health centers and hospitals where the antivirals are now available for patients. People can take Pfizer’s Paxlovid and Merck’s and Ridgeback Biotherapeutics’ molnupiravir, also known as Lagevrio, at home shortly after they develop symptoms.
- GAO Report: HHS Agencies Need to Develop Procedures and Train Staff on Reporting and Addressing Political Interference. Since the onset of the COVID-19 pandemic, there have been allegations of political interference affecting scientific decisions at several HHS offices and agencies. Through semi-structured interviews and a confidential hotline, employees at CDC, FDA, and NIH told GAO they observed incidents that they perceived to be political interference but did not report them fearing retaliation, being unsure how to report issues, or believing agency leaders were already aware. Some respondents from CDC and FDA stated they felt that the potential political interference resulted in the alteration or suppression of scientific findings, or it may have resulted in the politically motivated alteration of public health guidance or delayed publication of COVID-19-related scientific findings. GAO made 7 recommendations for executive action focused on developing reporting procedures and training by the four agencies.
- CIDRAP to develop vaccine roadmap for future coronavirus threats. CIDRAP has received $1 million in grants to create a Coronavirus Vaccines Research and Development (R&D) Roadmap for developing vaccines that provide broad protection against betacoronaviruses or a subset of betacoronaviruses, which mainly circulate in bats and rodents, but can spill over into human populations. CIDRAP’s director, Michael Osterholm, said the roadmap “will provide a framework for the development of broadly protective coronavirus vaccines to ensure that we are prepared to respond” to future SARS-CoV-2 variants or other viruses with pandemic potential.
- Distribution facility recalls 121K pounds of ground beef. Lakeside Refrigerated Services, a Swedesboro, N.J. establishment, is recalling approximately 120,872 pounds of ground beef products that may be contaminated with E. coli O103, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The problem was discovered during routine FSIS testing of imported products. There have been no confirmed reports of illness or adverse reactions due to consumption of these products.