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Tuesday, July 27, 2021

Delta variant symptoms: Different? Worse? Here’s what to know

The Delta variant shares some characteristics with the original variant of the COVID-19 virus, but it also differs in the types of symptoms.

Centers for Disease Control and Prevention (CDC) director Rochelle Walensky said in a press conference Tuesday that the variant “behaves differently” from other strains of COVID-19.

Here is what to know about the Delta variant and its symptoms.

What is the Delta variant of COVID-19?

The “Delta variant,” also known by its scientific name as “B.1.617.2,” was a strain of the coronavirus first identified in October in Maharashtra, India.

The strain was first named the “Delta variant” by the World Health Organization after the global health agency implemented a naming system based on Greek letters this month.

Although it is just one out of many variants that are spreading around during the pandemic, World Health Organization officials have called it “a variant of concern.”

The Delta variant also has split into several sub-variants, including one that is widespread in the United Kingdom.

Are the Delta variant symptoms different from regular COVID symptoms?

The Delta variant’s symptoms differ slightly from the original variant of the virus.

The variant has a wide range of symptoms including:

Stomach pain
Sore throat
Headache
Stuffy nose
Loss of appetite
Vomiting
Nausea
Joint pain
Hearing loss

In most cases, patients with the variant are more likely to be hospitalized, suffer other complications, and require oxygen.

If I am fully vaccinated, do I need to worry about the Delta variant?

If you are fully vaccinated, your chances of getting the Delta variant of COVID-19 have significantly decreased.

And although fully vaccinated people can experience symptoms and test positive for COVID-19 in breakthrough cases, being vaccinated diminishes the chance of becoming seriously ill or needing to be hospitalized from the virus.

“So far, the vaccines that are here in the United States are effective, even against the Delta variant. It doesn’t mean you can’t get infected at all, but hospitalizations and deaths are significantly less likely to happen than if you’re not vaccinated,” said Dr. Gabe Kelen, director of emergency medicine at Johns Hopkins Medicine in Baltimore.

A U.K. study published in May showed that two doses of the Pfizer vaccine were 88% effective at preventing against symptomatic infection and 96% effective against preventing hospitalization.

Moderna announced in a June 29 press release that its vaccine was effective against multiple variants of concern, including the Delta variant.

A July 1 press release from Johnson & Johnson stated that the vaccine showed promise against the Delta variant in laboratory testing.

If I am partially vaccinated, what is my risk for catching the Delta variant?

The best protection against the Delta variant if you are partially vaccinated is to receive a full dose of a vaccine.

The CDC strongly recommends that you wear a mask indoors and remain socially distanced until you are able to complete your 14-day waiting period after your second dose of the Pfizer or Moderna shot or the one-dose Johnson & Johnson shot.

What is the risk of catching the Delta variant for unvaccinated people?

People who are unvaccinated against COVID-19 are at the highest risk for catching the Delta variant, according to the CDC.

The Delta variant now accounts for more than 80% of U.S. COVID-19 cases, the vast majority coming from unvaccinated people, according to health officials.

https://www.nj.com/coronavirus/2021/07/delta-variant-symptoms-are-they-different-when-do-they-appear-heres-what-to-know.html

CDC Confirms Viral Loads In Vaccinated With Delta 'Indistinguishable' From Unvaccinated

The Centers for Disease Control reversed course Monday and said it now recommends indoor masks for the vaccinated in all areas of the country where COVID infections are surging. CDC director Dr. Rochelle Walensky cited unpublished data from recent days suggesting that vaccinated people may be able to spread the Delta variant just as easily as unvaccinated people.

We're back in a phase of constantly shifting information and data — and just last week we had experts casting doubt on whether vaccinated and mildly symptomatic or asymptomatic cases should be counted as "breakthrough" cases, and others casting doubt on whether vaccinated people could spread the virus easily.

But as was expected, the CDC changed its tune about masking on Tuesday, recommending that vaccinated people resume wearing masks in crowded indoor settings. And, it should be noted, that while outdoor gatherings are still being considered safe, some experts are also now casting doubt on whether that's still true with the Delta variant. Dr. Eric Feigl-Ding, one of the world's leading epidemiologists, pointed to some recent outdoor "fleeting" transmission cases in Australia that appeared to happen without any close contact between individuals.

As the Associated Press notes, Walensky cited data from the last few days, still unpublished, taken from 100 samples from vaccinated and unvaccinated individuals with COVID infections. They found that the amount of virus in the noses and throats of vaccinated infected people was nearly "indistinguishable" from what was found in unvaccinated people, confirming what some experts have suspected. The increased viral load associated with the Delta variant appears to make vaccinated people equal spreaders of the virus. Walensky said that the data was "concerning enough that we feel like we have to act."

Last week, UCSF infectious disease expert Dr. Monica Gandhi tried to quell fears of this, saying that some of these mild and asymptomatic cases could be turning up "dead viral particles in your nose" that trigger positive tests. But she questioned whether those cases are as worrisome as those in unvaccinated people.

So, again, we're in a place of wondering who to believe.

Speaking at a White House press conference today, Press Secretary Jen Psaki said that CDC continues doing what it is is supposed to do as data and the need for new guidance changes. "That is their job," she said. "Their job is to look at evolving information, evolving data, an evolving historic pandemic and provide guidance to the American public." She reiterated that being vaccinated remains the best protection against the virus.

As for whether San Francisco is considered a high-transmission area by the CDC right now, it is. According to the CDC's tracker, Alameda, Contra Costa, San Francisco and Solano counties are all areas of high transmission, while the rest of the Bay Area is in the "substantial transmission" category.

One more worry: For the last two days on Twitter, Dr. Feigl-Ding has been stressing studies out of England that suggest that COVID-19 infections appear to cause cognitive declines even among those who have mild or even asymptomatic cases — though the cognitive declines were sharper among those who were hospitalized with severe cases.

"Folks — gonna level with you — I would not want this for myself or anyone I know," Feigl-Ding said. "Death is not the only bad outcome of #COVID19 — even if we survive, there are huge chronic consequences... Avoid infection not just hospitalization!"

Furthermore, in today's new CDC guidance, they are now recommending masks for all teachers, staff, students, and visitors to schools, regardless of vaccination status.

https://sfist.com/2021/07/27/cdc-confirms-that-viral-loads-in-vaccinated-people-with-delta-are-indistinguishable-from-unvaccinated/

'Medical freedom' law outlaws requiring COVID-19 vaccine to access public spaces

New Hampshire residents cannot be required to get a COVID-19 vaccine in order to "access any public facility, any public benefit, or any public service" according to a new bill signed into law by Republican Gov. Chris Sununu.

The so-called "medical freedom" bill does not override state vaccine law, which "requires that all children enrolled in any school, pre-school, or child care have certain immunizations to protect them and those around them from vaccine preventable diseases," according to the New Hampshire Department of Health and Human Services.

The COVID-19 vaccine is not currently listed as a requirement for attending school, nor is it approved for children younger than 12.

Other exceptions to the new law include correctional facilities, such as jails and prisons, where immunizations can be mandated "when a direct threat exists," as well as county nursing homes and medical facilities operated by the state.

"As he has long said, Governor Sununu believes that private entities have the choice to require vaccinations," Brandon Pratt, the governor's deputy communications director, told ABC News in a statement. "The simple fact remains that the safest thing one can do is get vaccinated as soon as possible to help increase the state’s already high vaccination rate."

New Hampshire's law stands in contrast to some other parts of the Northeast, which have edged toward mandatory vaccinations in recent days.

In New York City, Mayor Bill de Blasio announced Monday that COVID-19 vaccination would be compulsory for all city workers, including police officers, firefighters and teachers, starting Sept. 13. City workers will have the option of getting tested weekly for COVID-19 if they choose not to get vaccinated.

"We’re doing this out of a sense of urgency," de Blasio said. "It is about protecting the workforce, their health and safety, and the people they serve."

New Hampshire's vaccination rate is slightly higher than the national average. As of Sunday, 64% of residents had received at least one dose, and 58% were fully vaccinated, according to the Centers for Disease Control and Prevention. By comparison, 57% of Americans have gotten at least one shot, and 49% are fully vaccinated.

https://abcnews.go.com/Health/medical-freedom-law-outlaws-requiring-covid-19-vaccine/story

Amid delivery delay, 6 countries study combining COVID-19 Sputnik V vaccine with others

As Russia's Gamaleya Institute was delayed in producing and delivering the second dose, trials are underway to assess whether it can be swapped with different vaccines to complete the schedule. Russia announced the start of studies on the combination with the AstraZeneca dosage. Other such analyzes are already being carried out in Argentina, Azerbaijan, the United Arab Emirates, Belarus and India.

After the delays in the delivery of the second component of the Sputnik V vaccine, Russia agreed to carry out combination studies with different inoculants in England, Azerbaijan, United Arab Emirates, Belarus and Argentina (RDIF) (Handout via REUTERS)

The COVID-19 Sputnik V vaccine was developed by the Gamaleya Institute of the Russian Federation, and became the first licensed in the world. 69 countries have already joined to authorize it for emergency use in their population, in response to the pandemic, and have made dose purchase agreements. It is a vaccine with a non-replicative viral vector, with a schedule of two different doses. Since March, the production and delivery from Russia of the second component has been delayed and today millions of people are anxiously waiting to receive the dose to complete the scheme. Last July 22, there were almost 6.6 million people in Argentina in that situation.

The delay in delivery from Russia prompted health authorities in various countries to initiate clinical trials to study whether the first dose of Sputnik V vaccine can be effectively and safely combined with a dose of a different vaccine.Several of these studies are already in progress. The latest trial to be announced is one that will evaluate the combination of a dose of Sputnik V with the vaccine developed by the University of Oxford with the company AstraZeneca.It will be done in Russia in collaboration with England. There are also studies in India, Azerbaijan, United Arab Emirates, Belarus, and Argentina.

Last May, the ethics committee of the Russian Ministry of Health had suspended the approval process for such clinical trials and had requested additional information. According to the Russian regulatory authority, five medical institutions in that country will carry out trials that will end in early March 2022.

The combination of the Oxford / AstraZeneca vaccine with Sputnik V will be studied in five clinical institutions in Russia (REUTERS / Andreas Gebert)

Both the AstraZeneca / Oxford and Sputnik V vaccines involve two doses, a starter and a booster. But Sputnik V uses different viral vectors for its two injections. Both vaccines are based on similar platforms, with a non-replicative viral vector.

So-called viral vector vaccines use harmless modified viruses as vehicles, or vectors, to carry genetic information that helps the body build immunity against future infections.

Trials in volunteers of a COVID-19 vaccine combining the injection of AstraZeneca / Oxford with Sputnik V have already been approved also in Azerbaijan, United Arab Emirates, India, Belarus and Argentina.

In Argentina, different trials were started to study vaccine interchangeability during the last month. One is being carried out in the City of Buenos Aires by the Buenos Aires Ministry of Health. It is done only with people who have received the first dose of Sputnik V more than 30 days ago, are over 21 years old and want to participate voluntarily. The efficacy and safety of different vaccines that already have authorization for emergency use by the Argentine regulatory agency, ANMAT, are tested.

In the City of Buenos Aires, the Ministry of Health launched a study with people who have received the first dose of Sputnik V. The efficacy and safety of different vaccines that already have authorization for emergency use by part of Argentina's regulatory agency, ANMAT (NA)

“The research question for the clinical trial is: Is it as effective and safe to give the first and second doses of the Sputnik V vaccine as the combination with other vaccines from other platforms? ”, Dr. Angela Gentile told Infobae, which is part of the research ethics committee of the trial in the City of Buenos Aires and of the National Commission for Vaccine Safety. The doctor explained it when the registration of volunteers was released.

To make comparisons between the different vaccines, the trial will divide the participants into several arms, including the second dose of Sinopharm and the second dose of AstraZeneca. The final results of the Buenos Aires trial have not yet been released. But the preliminary results would already show that the combination of Sputnik with the other vaccines could be a positive option.

What's more, a vaccine combination trial was also undertaken from the National Ministry of Health, with other provincial jurisdictions. As announced on Monday by the Minister of Health, Carla Vizzotti,part of the doses of messenger RNA vaccines from Moderna that were donated days ago by the United States Government will be included in the trial to evaluate vaccine exchange.

In Argentina, 53% of the population received at least one dose of the COVID-19 vaccine (EFE / Juan Ignacio Roncoroni / File)

This study - explained the Nation's health portfolio - is collaborative and federal: it is coordinated with the participating jurisdictions and researchers from the National Council for Scientific and Technical Research (CONICET). "The objective of the study is to have national evidence for decision-making based on the analysis of immunogenicity and safety of the use of different doses in the same scheme of the vaccines available at the moment in the country," he clarified in a statement.

Combinations between AstraZeneca vaccines, Moderna, Sinopharm and Sputnik-V, and will be compared with the results of people who have received the schemes without doing immunization exchanges.

The provinces of Buenos Aires, Córdoba, La Rioja, Mendoza and San Luis participate in this study. Includes volunteers over 18 years of age vaccinated with a dose of Sputnik V, AstraZeneca or Sinopharm vaccine up to 60 days prior to enrollment, with and without identified risk factors for COVID-19 who remain in the jurisdiction where their study began .

People with immunocompromise due to underlying disease or immunosuppressive treatment are excluded from the study; pregnant and lactating people and those who are registered in the Integrated Argentine Health Information System (SIISA) for having suffered from COVID-19 (symptomatic or asymptomatic); as well as those who have had a severe allergic reaction (anaphylaxis) to any vaccine.

The Minister of Health of the Nation Carla Vizzotti announced that Moderna's vaccines will also be included in a trial to evaluate a combination with Sputnik and the other vaccines that are authorized in the country.

Since the beginning of the year, there have been other trials around the world that have evaluated the vaccine combination, not including Sputnik V. England, Canada, Spain, South Korea and China have already started studies to evaluate other combinations. In South Korea, the health authority reported on May 20 that it would carry out a COVID-19 vaccine combination trial, with doses of the AstraZeneca product with those developed by Pfizer and other companies.

In China, the combination of doses of the COVID-19 vaccine developed by CanSino Biologics ( which will arrive in Argentina according to today's announcement by Vizzotti ) and a unit of Chongqing Zhifei Biological Products is being studied . There, the health authority has recognized that it is studying the possibility of combining the doses of the vaccine developed with different technologies to increase its effectiveness.

https://www.infobae.com/america/ciencia-america/2021/07/27/tras-la-demora-en-la-entrega-seis-paises-estudian-la-combinacion-de-la-vacuna-contra-el-covid-19-sputnik-v-con-otros-inoculantes/

Pfizer, AstraZeneca vaccine antibody levels start declining after six weeks: Lancet

According to a study published in The Lancet journal, total antibody levels begin to decline six weeks after complete immunisation with Pfizer and AstraZeneca vaccines and can drop by more than 50% over ten weeks.

The researchers from University College London (UCL) in the United Kingdom expressed concern that if antibody levels continue to fall at this rate, the vaccines’ protective effects, particularly against new variants, may begin to wear off.

However, they stated that the timing of such an event cannot be predicted at this time.

According to the UCL Virus Watch study, antibody levels are significantly higher after two doses of the Pfizer vaccine than after two shots of the AstraZeneca preventive, known as Covishield in India.

Antibody levels were also much higher in vaccinated people than in those who had previously been infected with SARS-CoV-2, according to the researchers.

“The levels of antibody following both doses of either the AstraZeneca or Pfizer vaccine were initially very high, which is likely to be an important part of why they are so protective against severe COVID-19,” said Madhumita Shrotri of the University College London Institute of Health Informatics.

“However, we found these levels dropped substantially over the course of two to three months,” Shrotri said in a statement.

According to the researchers, the findings, which were based on data from over 600 people aged 18 and up, were consistent across all groups of people regardless of age, chronic illnesses, or gender.

Although the clinical implications of waning antibody levels are not yet clear, the authors emphasise that some decline was expected, and current research shows that vaccines remain effective against severe disease.

Pfizer’s antibody levels dropped from a median of 7506 Units per millilitre (U/mL) at 2141 days to 3320 U/mL after 70 days or more.

Antibody levels in the AstraZeneca vaccine decreased from a median of 1201 U/mL at 020 days to 190 U/mL at 70 or more days, a five-fold reduction.

“When we are thinking about who should be prioritised for booster doses our data suggests that those vaccinated earliest, particularly with the AstraZeneca vaccine, are likely to now have the lowest antibody levels,” said Professor Rob Aldridge from UCL Institute of Health Informatics.

The findings support the researchers’ recommendation that adults who are clinically vulnerable, those aged 70 or older, and all residents of care homes for older adults be prioritised for booster doses.

Furthermore, those who received the AstraZeneca vaccine are likely to have much lower antibody levels than those who received the Pfizer vaccine, according to the researchers.

“This may also need to be considered when deciding who should be prioritised when boosters are rolled out,” Aldridge said in the statement.

The team acknowledged that the data had some limitations, such as a small sample size for some groups.

Because each individual only provided one sample, the researchers cannot yet confirm how quickly antibody levels drop for each individual, or whether they will continue to drop or reach a stable level over the next few months.

They also noted that different people will have varying levels of immunity based on their antibodies’ ability to neutralise viruses as well as their T-cell responses.

“Even when measurable antibody levels are low, there is likely to be continuing immune memory that could offer long-term protection,” the authors of the study noted.

They believe that more research is needed to determine whether an antibody level threshold is required for protection against severe disease.

https://insiderpaper.com/pfizer-astrazeneca-vaccine-antibody-levels-decline-six-weeks-lancet/

Regeneron, AZ team up on drugs for obesity 'superpower' gene

AstraZeneca has formed a partnership with Regeneron to investigate the potential of treating obesity using drugs directed at GPR75, a protective gene identified by scientists at the Regeneron Genetics Centre.

AZ’s buy into the programme comes a few weeks after Regeneron published findings in the journal Science suggesting that people with certain GPR75 mutations have 54% reduced risk of obesity, based on sequencing data from almost 650,000 people in the US, UK and Mexico.

The study found that individuals who have at least one inactive copy of the GPR75 gene have lower body mass index (BMI) and tend to weigh around 12 pounds less than those without the mutation.

AZ and Regeneron will collaborate on finding small-molecule drugs directed against the GPR75 target, splitting the costs of the programme and sharing any resulting profits from the endeavour.

When the GPR75 researh was published, Regeneron’s chief scientific officer George Yancopoulos, described the mutations as a “genetic superpower” that “provides hope in combating global health challenges as complex and prevalent as obesity.”

The protective effect has been validated in animal studies which found that mice genetically engineered to lack copies of the GPR75 gene gained 44% less weight than mice without the mutation when both groups were fed a high-fat diet.

The GPR75 mutation has also been linked to improvements in metabolic parameters, including glucose lowering, which puts the programme firmly in AZ’s wheelhouse given its focus on diabetes with drugs like its blockbuster SGLT2 inhibitor Farxiga/Forxiga (dapagliflozin).

At the moment AZ’s clinical-stage pipeline only lists one candidate for obesity, its large-molecule GLP-1/glucagon dual agonist cotadutide which has reached mid-stage testing for overweight and obesity in diabetics, chronic kidney disease associated with type 2 diabetes, and non-alcoholic steatohepatitis (NASH).

Drugs to treat obesity have struggled to make headway in recent years, leaving the category largely untapped, but there are signs of change.

Novo Nordisk’s once-daily injectable weight loss therapy Saxenda (liraglutide) has been a slow grower, but is on a blockbuster trajectory with first quarter sales topping $250 million. Meanwhile, follow-up GLP-1 agonist Ozempic (semaglutide) has shown encouraging results in a phase 3 trial, and its once-weekly dosing may encourage greater take-up.

Novo Nordisk applied to the FDA for approval of semaglutide in obesity in December, using an acquired priority voucher to speed up the review time. Looming on the horizon is Lilly’s tirzepatide, which has posted impressive weight-loss data in diabetes and is in phase 3 for obesity.

https://pharmaphorum.com/news/regeneron-az-team-up-on-drugs-for-obesity-superpower-gene/

Boehringer takes alteplase to phase 3 for COVID, but drops antibody

Boehringer Ingelheim’s latecomer antibody therapy for COVID-19 has been side-lined, as the company focuses its attention on its thrombolytic drug alteplase, heading into a phase 3 programme later this year.

The decision to discontinue development of BI 767551, an inhaled antibody, has been taken because of the “evolving landscape” in managing the pandemic including the success of vaccination programmes, the availability of multiple antibody therapies and the emergence of SARS-CoV-2 variants.

The drug had reached the phase 1/2 trial stage, and was intended as a treatment for severely-ill COVID-19 patients at the earliest possible time to reduce pressure on hospitals and prevent the worsening of acute respiratory distress syndrome (ARDS) – the runaway lung damage that can prove fatal in coronavirus infections.

The hope was that an inhaled antibody would reach higher levels in the lung, where it is most needed, than systemic antibodies.

However, with cases of COVID-19 declining in many countries it has been “challenging to further progress clinical development of this antibody and make it available to patients within a reasonable time frame.”

The company previously said the antibody might be suitable for a broader range of patients, for example those outside hospital settings and for prophylactic use in people at risk of exposure to SARS-CoV-2.

Boehringer meanwhile also tried to develop a TRPC6 inhibitor called BI 764198 for COVID-19, which had progressed to phase 2 testing, but called that programme to a halt after disappointing clinical results.

That leaves Actilyse (alteplase) as the last COVID-19 project standing at the German drugmaker, but here there is good news with “favourable” safety and efficacy data from an interim analysis of the phase 2b portion of its TRISTARDS study in 62 patients. Results from the study are expected next year.

Drugs like alteplase are used to dissolve blood clots in cardiovascular disease including ischaemic stroke.

As widespread clotting is a feature of some severe COVID-19 cases, TRISTARDS is evaluating whether daily intravenous doses of alteplase, given for up to five days on top of standard care, can reduce the time to clinical improvement or hospital discharge.

Boehringer invested €3.7 billion on R&D last year, the highest spend in its history, as it mobilised its scientists to seek out new therapies for COVID-19.

Another team from University College London (UCL) is also testing a nebulised formulation of alteplase in COVID-19 patients, starting a phase 2 last year, although no results from that study have been reported.

https://pharmaphorum.com/news/boehringer-takes-alteplase-to-phase-3-for-covid-but-drops-antibody/

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Tuesday, July 27, 2021