Vaccine News

New York-based Regeneron Pharmaceuticals, Inc. announced today positive data from two clinical trials evaluating REGEN-COV™ (casirivimab with imdevimab).

The Phase 3 trial (2069B) of recently infected asymptomatic COVID-19 patients, evaluating REGEN-COV 1,200 mg administered via subcutaneous (SC) administration, reduced the overall risk of progressing to symptomatic COVID-19 by 31% (primary endpoint) and by 76% after the third day. The trial also demonstrated that REGEN-COV shortened symptom duration and markedly reduced viral levels.

The second Phase 3 trial was jointly run with the National Institute of Allergy and Infectious Diseases. The trial enrolled 204 individuals without any COVID-19 symptoms who tested positive for the SARS-CoV-2 coronavirus but did not have anti-virus antibodies at baseline and were randomized to receive either 1 dose of REGEN-COV (1,200 mg) or placebo.

"COVID-19 transmission often occurs via infected people who do not yet have symptoms, so it is critical that we rapidly diagnose and treat these individuals for their own health and to prevent transmission," commented Katharine Bar, M.D., co-principal investigator of the trial and Assistant Professor of Medicine, Infectious Diseases, Hospital of the University of Pennsylvania, in a press statement.

"These data pave the way for REGEN-COV to be used before patients become symptomatic, with a more convenient subcutaneous administration."

The trial met all primary and key secondary endpoints. In addition to reducing the risk of symptomatic infections, the total number of weeks patients experienced symptoms was nearly cut in half (45%) with REGEN-COV, and the viral burden was reduced by more than 90%.

While not included in the initial analysis plan, researchers also found that 0 REGEN-COV patients and 6 placebo patients were either hospitalized or visited the emergency room because of COVID-19 during the 29-day efficacy assessment period.

The data build on previously announced results from the Phase 3 outcomes (2067) and Phase 2 virology (20145) trials in non-hospitalized COVID-19 patients.

"These Phase 3 data provide even more evidence that REGEN-COV, this time given to asymptomatic patients via convenient injections, can change the course of COVID-19 infection in non-hospitalized patients," added George D. Yancopoulos, M.D., Ph.D., President, and Chief Scientific Officer at Regeneron.

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.

The US Centers for Disease Control and Prevention (CDC) published Key Updates for Week #13, ending April 3, 2021, highlights 'Flu activity is unusually low at this time of year but may increase in the coming months.'

The CDC confirmed 1.0% of patient visits reported were due to Influenza-like-Illness (ILI). This ILI percentage is below the national baseline of 2.6%.

And the CDC reported the current hospitalization rate is much lower than average for this point in the annual flu season and lower than rates for any season since 2005.

Furthermore, only one influenza-associated pediatric death occurring during the 2020-2021 season has been reported to CDC. This data is far lower than most flu season, including last year when 198 influenza-associated pediatric deaths were confirmed.

The annual flu vaccine is the best way to protect against flu and its potentially serious complications. Influenza vaccines protect people against the viruses that research indicates are circulating during the flu season, says the CDC.

A list of 2020-2021 flu season vaccines is posted on this webpage. And to learn about the upcoming 2021-2022 flu season in the Southern and Northern Hemispheres, please visit this Precision Vaccinations webpage.

'The COVID-19 pandemic disrupted both in-person learning and routine well-child visits for many children over the last year,' commented Dr. Nancy Messonnier, Senior Official, CDC National Center for Immunization and Respiratory Diseases, in a media statement issued on April 9, 2021.

'As a result, too many children have fallen behind on receiving recommended vaccines.'

'We all want our kids to be back in school safely, and that means getting caught up on vaccines that were missed over the last year.'

According to the CDC’s public sector vaccine ordering data, there is a 14% decrease in 2020-2021 orders compared to 2019.

The most obvious decrease is the measles vaccine ordering is down by more than 20%.

Measles outbreaks occur when people who are not protected from the virus are infected and spread the disease to unvaccinated or under-vaccinated populations. According to the CDC, around 90 percent of people who are not protected will become infected following exposure to the measles virus.

'Kids need to get caught up now so that they are protected as they go back to in-person learning. Catch-up vaccination will require efforts from healthcare systems, health care providers, schools, state and local governments, and families,' concluded Dr. Messonnier.

The CDC says 'vaccination providers should adhere to the standards for child and adolescent vaccination practices. These standards are published by the National Vaccine Advisory Committee and define appropriate vaccination practices for both public and private sectors for 2021.

In the USA, the M-M-R-II vaccine is commonly available. It is indicated for simultaneous vaccination against measles, mumps, and rubella. This vaccine is usually given to people 1-year-old or older.

Globally, measles cases surged in 2019, reaching the highest level in 23 years, reported the World Health Organization (WHO). Measles fatalities climbed nearly 50 percent since 2016, claiming an estimated 207,500 lives in 2019 alone, reported the WHO on November 12, 2020.

“We know how to prevent measles outbreaks and deaths,” stated Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, in a related press statement. “These data send a clear message that we are failing to protect children from measles in every region of the world.”

“We must collectively work to support countries and engage communities to reach everyone, everywhere with measles vaccine, and stop this deadly virus.”

Australian researchers published a study in BMC Infectious Diseases on April 7, 2021, that found antibiotics were initiated less frequently, and antivirals (oseltamivir) used more frequently in patients diagnosed with influenza using rapid polymerase chain reaction (RPCR) tests compared with standard multiplex PCR (MPCR) tests.

This retrospective cohort study of positive influenza RPCR and MPCR patients was performed utilizing data from the 2017 influenza season. Overall, 122 RPCR and 362 MPCR positive influenza patients were included in this study.

Commencement of antibiotics was less frequent in the RPCR than MPCR cohorts (51% vs. 67%).

People at high risk of complications from influenza who were tested with the RPCR were more likely to be treated with oseltamivir compared to those tested with the MPCR (76% vs. 63%; p = 0.03, OR 1.81; 95% CI 1.07–3.08).

Subgroup analyses of higher-risk patients for complications of influenza would suggest that RPCR testing leads to fewer missed opportunities for oseltamivir treatment than MPCR testing (24% vs. 37%, respectively).

Early oseltamivir use has benefits in improving clinical symptoms, reducing the risk of lower respiratory tract infections, and preventing hospital admission when used in influenza-positive patients.

In summary, these researchers stated, 'The use of a rapid influenza PCR test was associated with reduced inappropriate antibiotic use and increased appropriate oseltamivir use in patients at high risk of influenza complications.'

The Center for Infectious Disease Research and Policy at the University of Minnesota, the University of Texas Medical Branch, an expert team of task force members worldwide, and the World Health Organization have developed a draft Zika virus (ZIKV) Research and Development Roadmap. 

The roadmap is a key component of the WHO’s R&D Blueprint, a global strategy and preparedness plan that allows the activation of R&D activities in advance and during epidemics.

The purpose of the roadmap is to accelerate the development and implementation of effective medical countermeasures for ZIKV to reduce morbidity, mortality, and transmission.

The roadmap identifies the vision, strategic goals, and aligned milestones to develop effective diagnostics, therapeutic agents, and vaccines for ZIKV.

Submit your comments to the team on the draft roadmap using this online form. 

The Canadian Council of Chief Medical Officers stated on April 7, 2021, 'As we accelerate vaccination in Canada, we understand that everyone is looking forward to returning to a sense of normalcy.'

'We will be able to do this gradually based on local and regional COVID-19 activity, but we need to be careful.'

For example, Toronto Public Health issued a statement on April 6th confirming schools will be shut down as the city reported 955 new cases. The closure means more than 300,000 students, including those who attend private or independent schools, will return to learning from home exclusively.

And Ontario has declared its third province-wide state of emergency, issuing a stay-at-home order effective on April 8th. 

'COVID-19 variants of concern are causing a rapid resurgence in Canada and threatening the sacrifices we have made to prevent and control COVID-19. We cannot let our individual and collective guards down until there is sufficient population protection from vaccination.'

'This means that for now, everyone needs to continue with public health measures that we know are effective, regardless of whether you have received one or two doses of vaccine or are not yet vaccinated.'

'As vaccination rolls out across Canada, it provides us with the opportunity to consider how best we can adapt public health measures and gradually lift the most restrictive ones.'

'As Chief Medical Officers of Health, we are committed to reviewing the evidence to inform when and how it is safe to relax these measures. We will continue to work together to provide clear and evidence-informed advice as the science and situation evolve, to keep everyone in Canada safe and healthy.'

The European Medicines Agency (EMA) announced today its safety committee (PRAC) concluded 'that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).

The PRAC noted that the blood clots occurred in veins in the brain (cerebral venous sinus thrombosis) and the abdomen (splanchnic vein thrombosis) and in arteries, together with low levels of blood platelets and sometimes bleeding.

Furthermore, the 'EMA confirmed the overall benefit-risk of Vaxzevira vaccination remains positive.'

In reaching its conclusion on April 7, 2021, the PRAC considered all currently available evidence, including the advice from an ad hoc expert group.

The EMA reminds healthcare professionals and people receiving the vaccine to remain aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within 2 weeks of vaccination. So far, most of the cases reported have occurred in women under 60 years of age within 2 weeks of vaccination. Based on the currently available evidence, specific risk factors have not been confirmed.

People who have received the Vaxzevria vaccine should seek medical assistance immediately if they develop symptoms of this combination of blood clots and low blood platelets.

According to the EMA, one plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one sometimes seen in patients treated with heparin (heparin-induced thrombocytopenia, HIT). The PRAC has requested new studies and amendments to ongoing ones to provide more information and take any further actions.