I want to draw attention to and thank you for provisions of the American Rescue Plan Act of 2021 that have not been widely reported. In comprehensive legislation there is a provision of $ 10.8 billion to tackle the impact of Covid-19 abroad. This provision will provide life-saving overseas health and humanitarian assistance to poor countries struggling with the effects of the pandemic.
Some may be tempted to think, “Don’t we need to take care of our own people first? Are we responsible for the health of people in other countries? “Of course, every step needs to be taken to make the Covid-19 vaccine available here for those who need it and are looking for it, as well as provide assistance to families and communities affected by the pandemic. But if we are too narrow in our view, it can hurt us.
We all know that Covid-19 entered our country from other countries. New virus mutations have also come from other countries, including Brazil, South Africa and the UK. It is impossible to end a pandemic by simply tackling it in the US as if we could build a wall around our country to prevent it. I recently heard someone say that a virus outbreak is everywhere.
It was recently reported in the New York Times that 90% of the 400 million vaccines shipped to date have been sent to wealthy and middle-income countries. So, sharing resources with those in need seems orderly. The recent decision by the United States to send four million doses of vaccine to Canada and Mexico, our two closest neighbors and major trading partners, is a sign of a hopeful international partnership.
RIO DE JANEIRO (Reuters) – Brazil has recorded the first confirmed case of a highly contagious variant of the coronavirus found in South Africa, a new red flag for a country already ravaged by the world’s highest daily death toll triggered by a widespread local variant.
Last week, scientists at the Butantan Biomedical Institute said the case, identified in a woman in the state of Sao Paulo, may be a new local variant. Further analysis confirmed it to be the first known local case of a variant widely circulating in South Africa and elsewhere.
Scientists fear clashes between the South African variant and the already rampant Brazilian variant, known as P.1, are both more contagious and possibly deadlier than the original version of the coronavirus and have led to an accelerated spike in COVID-19.
“This could be a big duel,” said Maria Carolina Sabbaga, one of the Butantan coordinators to study the new variant. “I think P.1 has taken over. I’m not sure if South Africa will overtake P.1, let’s see. “
The South African variant appears to reduce protection from current vaccines in clinical trials and in vitro studies.
Brazil is in the midst of a brutal wave of COVID-19, setting record deaths every week. On Tuesday, the Health Ministry reported a one-day record of 4,195 deaths.
The outbreak in South America’s largest country may overtake the United States to become the world’s deadliest, some medical experts estimate.
José Patané, a Butantan researcher, said the South African variant most likely arrived in Brazil after traveling through Europe towards the end of 2020.
The first local diagnosis, a woman in her 30s in the city of Sorocaba, not traveling abroad or having contact with someone who did, suggests local community transmission, the researchers said in a study published on Sunday as a preprint on the medRxiv server (bit.ly/3dIXEl1).
ROLLOUT SLOW VACCINE
It is likely that a surge in the South African variant could further complicate the slow rollout of a Brazilian vaccine.
Brazil’s COVID-19 immunization program is built around vaccines from AstraZeneca Plc and China Sinovac Biotech Ltd, which have been shown to be effective against Brazilian variants in preliminary studies, according to officials.
Research described at a press conference on Wednesday showed Sinovac injections were 50% effective at preventing symptoms of COVID-19 in a study of nearly 68,000 healthcare workers in Manaus, where the P.1 strain first emerged as the main variant. The results of the interim analysis are expected to be published in the coming days.
In a South African clinical trial, the South African variant reduced the efficacy of AstraZeneca injections to only 10.4%.
Immunizations have been slow to pick up in Brazil after the government withdrew last year in obtaining vaccines, as other countries race to secure supplies.
President Jair Bolsonaro has changed his tone about vaccines, touting hitherto underestimated injections. But the former captain of the right-wing army continues to oppose social distancing and mask requirements that health experts say are essential to curbing transmission of the virus.
Under pressure from business leaders desperate to vaccinate their workforce and reopen operations, the lower house of Congress has adopted controversial legislation to allow the purchase of vaccines from the private sector.
A version of the bill, which was first passed on Tuesday, would allow businesses to obtain a vaccine to inject their employees with as long as they donate the same amount of injections to the public health system. Under current rules, businesses can only do so after the country has a fully vaccinated risk group outlined in the national immunization plan.
Proposed amendments to the new law are still awaiting a decision by the lower house before the bill is submitted to the Senate.
Bolsonaro will meet with a group of business leaders including BTG Pactual founder Andre Esteves and Banco Bradesco chairman Luiz Carlos Trabuco Cappi on Wednesday evening, local media reported, with a personal vaccine dosing plan among the items on the agenda.
The crossover allows the participant to continue the trial and remain blind
Ensure that all trial participants receive the active vaccine
south Africa and British crossover guns began; US / Mexico PREVENTS-19 crossovers planned
GAITHERSBURG, Md., April 5, 2021 / CNW / – Novavax, Inc. (Nasdaq: NVAX), a biotech company developing next-generation vaccines for serious infectious diseases, today announced the initiation of a cross-arm in two ongoing clinical trials of NVX-CoV2373, the company’s COVID-19 vaccine candidate. The crossover confirmed the administration of the active vaccine for all participants in the trial and that it was started for the Novavax Phase 2b trial entry south Africa and the all-important Phase 3 trial at great Britain.
Under the updated Novavax clinical trial protocol, all participants in the UK and US Phase 3 trials will be offered the opportunity to receive an additional round of injections. Participants who choose to do so will receive an additional two-dose regimen of either the vaccine (for those who initially received the placebo) or the placebo (for those who initially received the vaccine). Participants in the South Africa Phase 2b trials will receive the active vaccine for those who initially received the placebo, or the active vaccine booster dose for those who initially received the active vaccine. Participants in all three trials will remain unaware of their course of treatment to maintain the ability to assess efficacy in each trial, and all will be followed up for up to two years to monitor safety and protective durability of the vaccine. In the trials that took place on south Africa and great Britain, half of the participants initially received the active vaccine while two thirds of the participants in PREVENTION-19, trials were conducted in the US and Mexico, initially received an active vaccine.
“The cross-gun ensures that all participants have access to the active vaccine candidate while allowing Novavax to continue to monitor the long-term safety and efficacy of our vaccine,” said Filip Dubovsky, MD, Chief Medical Officer, Novavax. “We thank the volunteers who are stepping forward to take part in our clinical trials, without which we would not have been able to develop, study and ultimately deliver what we hope will be a significant tool in fighting COVID-19.”
The company is also planning a cross in the PREVENT-19 study, which it hopes will be able to read preliminary clinical data during the second quarter. In addition, the company plans to expand the trial to cover pediatric and adolescent arms, which is also expected to start in the second quarter.
About the NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence SARS-CoV-2, the virus that causes COVID-19. NVX-CoV2373 is manufactured using Novavax’s recombinant nanoparticle technology to generate antigen derived from the corona virus spike protein (S) and added with Novavax’s patented saponin-based Matrix-M ™ to enhance immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains a purified protein antigen that cannot replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induces antibodies that block the binding of spike proteins to cellular receptors and provide protection from infection and disease. It is generally well tolerated and elicits a strong antibody response in Phase 1/2 clinical trials.
NVX-CoV2373 is being evaluated in two important Phase 3 trials, a UK trial showing 96.4% efficacy against the native strain and 89.7% overall, and the PREVENT-19 trial in the US and Mexico which started on December 2020. It is also being tested in two ongoing Phase 2 studies that started in August 2020: Phase 2b trial entry south Africa which demonstrated 48.6% efficacy against the emerging flee variant, and the continuation of Phase 1/2 in the US and Australia.
The NVX-CoV2373 is stored and stable at 2 ° – 8 ° C, allowing the use of existing vaccine supply chain channels for distribution. It is packaged in a ready-to-use liquid formulation in 10-dose bottles.
About the Matrix-M ™
Novavax’s patented saponin-based Matrix-M ™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells to the injection site and increasing antigen presentation in local lymph nodes, enhancing the immune response.
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes health improvement globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to meet pressing global health needs. Novavax is conducting final-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu ™, the quadrivalent nanoparticle influenza vaccine, meets all major objectives in the critical Phase 3 clinical trials in older adults and will be developed for regulatory filings. Both vaccine candidates incorporate Novavax’s saponin-based Matrix-M ™ adjuvant to enhance immune response and stimulate high levels of neutralizing antibodies.
The statements here regarding the future of Novavax and the continued development of its vaccines and adjuvant products are forward-looking statements. Novavax warns that these forward-looking statements carry a lot of risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by those statements. These risks and uncertainties include those identified under the heading “Risk Factors” in Novavax’s Annual Report on Form 10-K for the year ended. 31 December 2020, as filed with the Securities and Exchange Commission (SEC). We warn investors not to rely too much on the forward-looking statements contained in this press release. You are encouraged to read our archives with the SEC, available at sec.gov, for discussion of this and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we are under no obligation to update or revise any statements. Our business is subject to substantial risks and uncertainties, including those referred to above. Investors, potential investors and others should carefully consider these risks and uncertainties.
1 Clinical trial protocol can be found in the Resources section of the Novavax website and will be updated accordingly.
The pandemic has changed the way we consume and perceive fashion. The latest Paris Fashion Week is fully digital. For the first time in the event’s history, proceedings begin with the work of students from the Paris-based French Institute of Fashion (IFM), who view their creations through significant cultural and political perspectives. Meanwhile in Johannesburg, South African designer Thebe Magugu is dedicated to reviving the “exploitation of the blax” cultural movement of the 1970s.
SAO PAULO (Reuters) – Brazil has detected a new variant of COVID-19 in the state of Sao Paulo that is similar to the first seen in South Africa, the head of the state’s Butantan biomedical agency said on Wednesday.
Speaking at a press conference a day after Brazil experienced a record 3,780 deaths in a day, Butantan President Dimas Covas said patients with the variant had no travel history to South Africa.
The South African variant has worried public health experts as there are questions about how effective the current vaccine is against it. Brazil is also grappling with a homemade variant, called P1, which appears to have sparked a series of record-breaking infections.
“This is a similar variant to South Africa, although there is no travel history or contact with travelers from South Africa,” Covas said. “It is possible that it is an evolution from our P1 to this mutation in South Africa.”
Brazil is currently grappling with the worst phase of its outbreak, the second deadliest in the world after the United States. Slow vaccine rollouts and a lack of social distancing are contributing to Brazil’s increasing caseload, pushing the country’s health care system to the brink.
Brazil currently accounts for about a quarter of daily COVID-19 deaths worldwide, more than any other country.
Brazilian President Jair Bolsonaro, who has come under fire for his handling of the pandemic, on Tuesday signed an executive order to disburse 5.3 billion reais ($ 918 million) in new loans to fight the COVID-19 pandemic.
The new loans will be used to shore up Brazil’s health system, the Ministry of Finance said. The Health Ministry, which will receive the funds, said it would use it in more than 2,600 public health clinics, as well as to build more hospital beds.
Reporting by Eduardo Simoes Written by Gabriel Stargardter Editing by Brad Haynes and Sonya Hepinstall