Operation Warp Speed is gearing up for widespread adoption of a potential vaccine, including state and community-specific guidelines – even as high-level health officials say a widely available vaccination is unlikely to be ready for the general public until 2021.
The U.S. Department of Health (HHS) announced its vaccine distribution strategy, which is reinforcing a vaccine schedule that is in line with what health officials say – likely in January 2021
Paul Mango, assistant chief of staff for policy at the Department of Health and Human Services, told Bloomberg News on Wednesday that all Americans should have access to a shot by April 2021 – a more realistic timeframe suggested by Dr. Anthony Fauci and Centers for Robert Redfield, director of disease control (CDC), spoke to a Senate panel on Wednesday. He added that the US can expect to resume “normal life” in the second half of next year.
Redfield noted that small-scale vaccinations could start and go up in November or December, and it “takes six to nine months to vaccinate the American public”.
Political pressure has created confusion and growing skepticism about a safe and effective vaccine. A Trump ally, Michael Caputo, who served as HHS top spokesman, is taking a 60-day vacation after he and his staff tried to meddle in the CDC’s dissemination of information about the pandemic.
But the CDC has continued to share its data and released a more detailed playbook on Wednesday, including a look at various states, territories, and tribal communities for vaccine distribution. On a call with reporters, officials said the federal government was ready to use vaccines within 24 hours of an emergency approval or an application for a biologics license from the U.S. Food and Drug Administration (FDA).
Redfield noted that the company that chose to distribute the vaccine, McKesson (MCK), is already working with the federal government to distribute 80 million doses of flu and other vaccinations per year, and has the option of up to 900 million Scale cans.
In line with these efforts, the Trump administration is introducing a $ 16 million tracking system to aid in the delivery, distribution and administration of COVID-19 vaccines. However, some say the efforts are at odds with existing state-level tracking systems.
The country is waiting for its front-runners, including Moderna (MRNA) and Pfizer (PFE) with BioNTech (BNTX), to complete phase 3 trials. Pfizer recently hosted an Investor Day event and found it is on track to deliver efficacy results by the end of October.
In an analyst report, SVB Leerink found that by the end of the year the company had 100 million cans and had made 450 million cans available. Overall, Pfizer is under discussion to provide up to 600 million – or a total of 1 billion – by next year.
Pfizer “is now severely overwhelmed by its original efficacy assumptions, and with 29,000 enrolled subjects and more than 12,000 receiving two doses, the efficacy signal could really be occurring any day,” the press release said.
In the meantime, however, antibody treatments have become increasingly the focus as the reality of widespread use of vaccines is in mid-2021. Using recovered patient blood and the antibodies it contains has been a promising and seemingly low-risk approach to tackling the global pandemic.
To that end, Eli Lilly (LLY) provided a promising update on Wednesday that showed that his antibody treatment resulted in a decrease in the amount of virus in a person’s body, thereby avoiding ventilators and death in a limited group of the population.
Daniel Skovronsky, Lilly’s chief scientist and president of Lilly Research Laboratories, said the results “confirm our belief that neutralizing antibodies can help in the fight against COVID-19.”
The news is a positive signal for others like Regeneron (REGN), which is also working on an antibody cocktail.
Growing global concern about the ongoing pandemic has led several vaccine companies to focus on equitable distribution around the world. Larger pharmaceutical companies already have such an infrastructure and relationships, but smaller newcomers such as Moderna and Novavax (NVAX) are also pursuing this.
Novavax recently announced a relationship with the Serum Institute of India, while Moderna announced on Wednesday that it was in an office in Switzerland, a country that has been optimistic about Moderna’s vaccine candidate and is the company’s main high-volume manufacturing partner is active, has laid the foundation stone. Lonza is based. The Swiss federal government is buying 4.5 million cans of Moderna’s candidates.
In the meantime, Europe is struggling to cope with the coronavirus outbreak resurgence in parts that have reopened, but now there are new increases in positive diagnoses. These countries had decided to open earlier than Italy and Spain, which were the hotspots in Europe, including the Czech Republic and France.
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