Yesterday was a rest day. We were both worn out after our incredible breakfast provided by Ashbourne Boutique Guest House – eating dish after dish takes a lot of work. As a matter of fact, other than read and nap the only other thing we did all day was eat two more meals.
Today we are smarter. No, we didn’t eat less at breakfast but we did take a wine walking tour.
Tim, the owner of our hotel, took the time to map out what he thought was a walk we would enjoy and marked what he thought were the best wineries to stop and explore.
The hotel’s entire staff was incredible and I am guessing because they took their cues from Tim. Tim provided information on about ten local restaurants, made dinner reservations for us, provided driving directions, a history of Franschhoek and the background on how his family and he had moved from Germany to South Africa six years earlier.
It was a four-block walk from the hotel to the main two-lane highway. Running parallel to the highway but about 20 feet nearer the open fields was a six foot or more wide sidewalk. Even with the Covid keeping people home, the sidewalk had a number of walkers like ourselves.
”…A total of 411 myocarditis or pericarditis, or both, events were observed among 15 148 369 people aged 18–64 years who received 16 912 716 doses of BNT162b2 and 10 631 554 doses of mRNA-1273. Among men aged 18–25 years, the pooled incidence rate was highest after the second dose, at 1·71 (95% CI 1·31 to 2·23) per 100 000 person-days for BNT162b2 and 2·17 (1·55 to 3·04) per 100 000 person-days for mRNA-1273. The pooled IRR in the head-to-head comparison of the two mRNA vaccines was 1·43 (95% CI 0·88 to 2·34), with an excess risk of 27·80 per million doses (–21·88 to 77·48) in mRNA-1273 recipients compared with BNT162b2….Interpretation
An increased risk of myocarditis or pericarditis was observed after COVID-19 mRNA vaccination and was highest in men aged 18–25 years after a second dose of the vaccine. However, the incidence was rare. These results do not indicate a statistically significant risk difference between mRNA-1273 and BNT162b2, but it should not be ruled out that a difference might exist. Our study results, along with the benefit–risk profile, continue to support vaccination using either of the two mRNA vaccines.
”…Local public health experts don’t know exactly why the area’s hospitals are seeing so few COVID patients, but they suspect it’s a combination of COVID strains that cause less severe illness, widespread immunity, and possibly even Texas’ warm climate…..COVID cases are still climbing across North Texas. Dallas and Tarrant counties could each see more than 600 new infections daily in the next several weeks, according to a June 1 forecast from UT Southwestern….though North Texas is seeing few hospitalizations currently, that could change quickly. Immunity from previous infections and vaccinations can wane within months…..Anyone age 5 or older is eligible for booster doses of the COVID-19 vaccine. Children ages 5 through 11 can get a booster shot five months after the initial Pfizer vaccine series. People 12 or older who are immunocompromised can get a second booster at least four months after their first booster dose, while anyone 50 or older can receive a second booster in the same time frame…”
FROM JOHNS HOPKINS SELECTIONS:
1. NOVAVAX VACCINE The US FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is meeting today to discuss and vote on the question of whether the benefits of Novavax’s 2-dose SARS-CoV-2 vaccine outweigh the risks of use among adults. The Novavax vaccine uses decades-old technology, and a vaccine using more traditional technology could help fill gaps in vaccination coverage among those who are hesitant to be vaccinated with shots using newer mRNA technology. In clinical trials, the vaccine demonstrated 90.4% efficacy in preventing mild, moderate, or severe infections with older variants, and 100% efficacy in preventing moderate or severe infection. However, it is unclear how effective the vaccine is against currently circulating Omicron subvariants. There also are concerns over the risk of the heart conditions myocarditis and pericarditis associated with the vaccine, particularly among young men, outlined in a briefing document for the meeting. These rare occurrences of heart inflammation also are associated with the Pfizer-BioNTech and Moderna mRNA vaccines. Notably, there is not enough data to evaluate the Novavax vaccine for use among pregnant women, children, or immunocompromised individuals.
If VRBPAC recommends the vaccine and the FDA grants emergency use authorization, after also evaluating information about the company’s manufacturing processes, the vaccine will be the fourth authorized for use in the US and could be available later this summer.
4.” …An accepted manuscript by researchers in Israel published last week in Clinical Infectious Diseases evaluates the effectiveness of Paxlovid in a real-world setting among vaccinated and unvaccinated adults during Omicron variant predominance. According to the study, treatment with Paxlovid reduced the risk of severe COVID-19 or death by about half (46%) regardless of vaccination status, while up-to-date vaccination reduced the risk 80%. Notably, Paxlovid was more effective in older patients, immunocompromised patients, and those with underlying neurological or cardiovascular disease, and no interaction was observed between Paxlovid therapy and vaccination status.”
5. Pfizer to Invest $120 Million to Produce COVID-19 Oral Treatment in the U.S. (Pfizer) Pfizer announced today that it will further strengthen its commitment to United States manufacturing with a $120 million investment at its Kalamazoo, Michigan, facility, enabling U.S.-based production in support of its COVID-19 oral treatment, Paxlovid. The investment will expand the production of active pharmaceutical ingredient and registered starting materials used in the manufacture of nirmatrelvir, a novel main protease (Mpro) inhibitor originating in Pfizer’s laboratories. This investment is another major step in Pfizer’s effort to bring more key biopharmaceutical manufacturing to the U.S., increasing Pfizer’s capability to produce and supply treatments and medicines for patients in the U.S. and around the world.
6. The Omicron variant of concern (VOC) continues to account for essentially all analyzed SARS-CoV-2 samples worldwide. Together, the BA.2 sublineages represent 86.2% of all sequenced specimens last week***. Both the BA.4 (4.1%) and BA.5 (8.8%) sublineages are increasing in prevalence, and collectively, the BA.1 sublineage represents less than 0.2% of sequenced specimens last week. The WHO now categorizes the Delta VOC as “previously circulating,” joining the Alpha, Beta, and Gamma variants.
1. Novavax COVID vaccine gets backing of U.S. FDA advisers
Advisers to the U.S. Food and Drug Administration on Tuesday voted to recommend authorization of Novavax Inc’s COVID-19 vaccine for adults.
2. Novavax says COVID vaccine for U.S. to be manufactured by India’s Serum
Novavax Inc said on Tuesday that its COVID-19 vaccine initially available in the United States, if authorized, will be manufactured by the Serum Institute of India.
3. Omicron sub-variants BA.4 and BA.5 account for up to 13% of COVID variants in U.S. – CDC
The BA.4 and BA.5 sub-variants of Omicron are estimated to make up nearly 5% and 8% of the coronavirus variants in the United States as of June 4, the U.S. Centers for Disease Control and Prevention (CDC) said on Tuesday.
”…But Covid cases could be undercounted by a factor of 30, an early survey of the surge in New York City indicates. “It would appear official case counts are under-estimating the true burden of infection by about 30-fold…”
(J. Harris: Readable. Contains some food for thought.)
”… Concerns about the high frequency of myocarditis in athletes infected with SARS-CoV-2, and the possibility of life-threatening arrhythmias, led to various protocols and the development of prospective registries. In the current study, the Outcomes Registry for Cardiac Conditions in Athletes Study Group prospectively followed 3675 athletes from 45 colleges and universities to assess their risk for adverse cardiovascular events after SARS-CoV-2 infection…Cardiovascular testing including electrocardiogram, troponin, echocardiogram, or cardiac magnetic resonance imaging was performed in 97% of athletes. Definite or probable myocarditis was found in 21 athletes (0.6%), who were temporarily restricted from sport and later cleared to resume...
During a median follow-up of 1.2 years among all athletes, only two cardiac events occurred (incidence rate, 0.05%). One was a cardiac arrest in an athlete subsequently discovered to have a preexisting genetic structural cardiac disease, and the other was atrial fibrillation that was possibly related to SARS-CoV-2 infection.
”…By the time the US Food and Drug Administration convenes a meeting late this month to discuss plans for updating booster shots in the fall, more than 200 days will have elapsed since Moderna and Pfizer began working on their Omicron vaccines…So what’s the holdup?…. reasons for the delay. To start, the virus keeps changing too quickly. There’s also conflicting data on the superiority of variant-specific boosters over what’s already available, casting doubt on their value. And with the majority of Americans yet to get even their first booster shot, the companies’ financial incentive for making new ones has diminished….In theory, designing the new vaccine is a simple matter of tweaking its mRNA sequence to match the genetic code of Omicron — But making enough of the vaccine to begin clinical trials takes at least several weeks…“Having the variant-specific vaccine only makes sense if that variant persists for a long enough period of time to vaccinate people against it…Running clinical trials to test the safety and efficacy of the shots is the most time-consuming step of vaccine development ― regulators need to be sure that the updated shots are safe…Although the Omicron boosters triggered somewhat higher antibody levels against that variant, Although the Omicron boosters triggered somewhat higher antibody levels against that variant, the original booster also worked fairly well…
In March, Moderna began testing a so-called bivalent booster that contains mRNA for both the original coronavirus and the Omicron strain — an effort to “hedge your bets” against the evolving virus, Thackray said. The FDA’s vaccine advisory committee will likely debate the relative merits of the original, Omicron, and bivalent boosters when it meets at the end of the month….But if the updated vaccines are not markedly better, companies may lack the financial incentive to actually produce them…And given that less than half of vaccinated Americans and fewer than one-third of all people in the United States have yet to get their first booster shot, the lack of urgency to make second-generation boosters probably shouldn’t come as a surprise……Throughout the pandemic, health officials have stressed that the goal of the vaccines is to prevent serious disease, hospitalization, and death. “I would argue that we’ve achieved that goal with the [existing] ancestral vaccine,”..“We are going to have to get used to mild and moderate infection and have a reasonable goal for this vaccine, because we are driving people crazy,…There is already booster fatigue.”…
Milton and the Norwegian both assure me that it will rain today!
GIVE US YOUR FEEDBACK. CLICK ON “COMMENT” TO TELL US WHAT YOU THINK or use one of the alternative methods for providing feedback.