Key Points:

• In today’s Recommendations for Industry, we provide a wrap-up of COVID news and events of the week. Read more below.
• The WHO is sending COVID-19 aide to India. India is nearing 400,000 daily new cases.
• In other global news, cases in Europe are declining while cases in Brazil are stabilizing. The P1 variant, first identified in Brazil is starting to become dominant in Brazil’s neighboring countries (including Lima, Peru, and Uruguay). In Lima, Peru, the P1 variant accounts for 40% of infections while it accounts for 75% of all new infections in Uruguay.
• While we’ve discussed this before, a new manuscript out in Clinical Infectious Disease has determined that the 2020 Sturgis Motorcycle Rally did indeed result in “widespread transmission of SARS-CoV-2 across the country.” At least 649 COVID-19 cases were identified (including secondary and tertiary spread to close contacts).
• Two recent studies, reported by CIDRAP, in England and Mexico highlight severe COVID outcomes for obese individuals, even for those who are young adults. In one study, researchers “found a significant link between BMI and age, with higher HRs for hospitalization.” In the other study, due to metabolic distinctions leading to the likelihood of “early-onset overweight or obesity,” “younger Mexican patients were infected early in the pandemic.”
• New York will fully reopen on July 1^st.
• Disneyland, in California has reopened to visitors. This is a move that California is slowly reopening too.
• Moderna has announced that its COVID-19 vaccine can be stored at refrigerator temperatures for 3 months and up to 7 months at -4F.
• Scientific American discusses that “Flu Has Disappeared Worldwide during the COVID Pandemic” and scientists and public health officials think it’s because “measures taken to keep the coronavirus from spreading also stop the flu.”
• There is a new experimental design for understanding COVID-19 disease progression and potential therapies, producing and utilizing lung organoids that can be infected with SARS-CoV-2. Read a summary of the study here.
• COVID Act Now answers some frequently asked questions about the COVID-19 vaccine including: What are the ingredients of the vaccines?

Friday COVID Wrap-Up

As has been discussed this week through TAG’s Key Point summaries and Recommendations articles, there is continued concern around COVID-19 variants, particularly in India which is continuing to set case-rate and mortality records. We are not yet seeing the strain in the US, and cannot be sure whether the country’s struggles are due to a lack of infrastructure or super transmissibility of the variant, but it has now been seen in Israel, so this is an area to continue to watch.

Studies also are finding that healthy lifestyles can have benefits in relation to COVID severity, with those with high BMIs (particularly those aged 20-39) or early-onset overweight or obesity are hospitalized at a greater rate than those with healthier body mass. Continued research is being conducted to establish whether BMI affects vaccine efficacy or risk of post-COVID-19 health consequences.

In addition, the vaccination picture is changing in the US, with shortages no longer being seen, but vaccination rates declining, as vaccine hesitancy continues in certain populations.

• In Wednesday’s Recommendations for Industry, we discussed the CDC’s newly published concessions for fully vaccinated people. Read more here.
• Yesterday, the CDC announced that fully vaccinated Americans can be maskless outdoors when doing activities (biking, running) and during outdoor gatherings with friends or outdoor dining at restaurants. However, the CDC continues to recommend mask-wearing when one is in large outdoor gatherings (like concerts or sports events) because there may still be unvaccinated individuals in these circles. The CDC recommends that you continue considering current COVID-19 spread in your community, “the number of people participating in the activity, and the location of the activity.” See the charts of activities considered safe for fully vaccinated individuals both indoors and outdoors.

• NPR reports on why Michigan continues to experience the highest rate of new US COVID-19 cases. Last week, Michigan had over 70 young children in hospitals. Michigan was especially hit hard by the B117 variant.
• CIDRAP reports on a Cleveland Clinic study, published in JAMA Network Open, that found that early in the COVID-19 pandemic, early virus subgroups were associated with higher death rates. However, as the pandemic continued, “strains quickly became less diverse and the once-dominant variants were outcompeted by more transmissible variants which were tied to improved survival in hospitalized patients.” Additionally, researchers also noted that, “Early public health mitigation measures likely prevented more strains from entering the community, leading to a rapid reduction in virus strain diversity and lowering the overall death rate.” Ultimately, researchers found that “the continued evolution of SARS-CoV-2 leads to less virulence.” This study showed how different strains arrived and were outcompeted, at least in Cleveland.
• In global news:
  • Yesterday, India’s new COVID-19 cases set another daily record, reaching over 3,000 cases for the first time.
  • Turkey’s national lockdown will last until May 17.
  • Brazil has rejected Russia’s Sputnik V vaccine “due to lack of data on safety, effectiveness, and quality.” Additionally, “Brazil's senate has launched an investigation into President Jair Bolsonaro's response to COVID-19, following months of the country's leader downplaying the threat and promoting untested treatments.”
• Canada is sending its army and Red Cross to Ontario to support the high rates of COVID cases in the region.
• The U.S. will send 60 million doses of unused AstraZeneca doses to other countries like India.
• Three new “real-world” studies highlight that the Pfizer and AstraZeneca vaccines (either one or two doses) were enough to cut infections and hospitalizations.
• A study published in NEJM of 35,000 pregnant individuals who’d received either the Pfizer or Moderna COVID-19 vaccines have found that the vaccines were not associated with increased risks of pregnancy-related or neonatal adverse events (aka: according to this study, the vaccines are safe for pregnant patients).
• Yesterday, Portugal recorded its first day of no deaths since August 2020.
• China has promised to meet Indian requests for COVID help.
• In Monday’s Recommendations for Industry, we discuss the resumption of the J&J vaccine and why vaccinations don’t eliminate the need for COVID protections. Read more here.  
• The FDA and CDC have lifted their recommended pause for the J&J COVID-19 vaccine. Ultimately, the two agencies have confidence in the safety and efficacy of the vaccine with the benefits far outweighing the potential risks. Current data shows the chance/risk of blood clots as being low and something they will continue to track. Read the News Release here.
• The European Union bloc is anticipating that fully vaccinated tourists may begin visiting Europe in the summer.
• In India, COVID-19 cases and deaths are rising as hospitals run out of oxygen and cremation sites are inundated. India has asked for global help, and countries throughout the world are stepping in with support (including sending oxygen). Day after day, India reports higher and higher daily case rates.
• The NYT reports that almost 8% of those who have received a first-dose of Pfizer or Moderna COVID-19 vaccines do not get a second dose. This is due to people choosing to not get their second shots due to symptoms experienced from the first shot, as well as vaccine providers canceling second-dose appointments due to not having the vaccine in stock or having the wrong type of vaccine.