- COVID-19 vaccine delivery will need as many community pharmacy vaccinators as possible (pharmaceutical-journal.com)Ambulatory Pharmacists Provide Value During Pandemic (pharmacypracticenews.com)
NHS England is preparing for the huge task of delivering COVID-19 vaccines, including through community pharmacies...Delivery of a COVID-19 vaccine to the public will require the participation of “as many of the workforce who are trained in vaccination as possible” from community pharmacy...Jill Loader, deputy director of pharmacy commissioning at NHS England and NHS Improvement, said there were “a number of different ways community pharmacy can get involved” in the COVID-19 vaccine delivery programme, with some community pharmacies expected to be commissioned as a vaccination site through a locally enhanced service...“We anticipate that we are going to need to use as many of the workforce who are trained in vaccination as possible,” she said...READ MORE
- Moderna’s COVID-19 vaccine gets 94.5% efficacy in phase III interim peek (bioworld.com)2nd virus vaccine shows striking success in US tests (apnews.com)Dynamic stability: Moderna flies high with storage-friendly COVID-19 vaccine bid (bioworld.com)
More good news emerged from the COVID-19 vaccine front, with Moderna Inc. reporting that its candidate, mRNA-1273, has met the statistical criteria pre-specified in the study protocol for efficacy in an interim analysis, with efficacy of 94.5%. The product is an mRNA vaccine encoding for a prefusion stabilized form of the Spike protein...Moderna plans to submit for an emergency use authorization from the FDA in the weeks ahead, and expects the application will be based on the final analysis of 151 cases with a median follow-up of more than two months. The study enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the NIH and the Biomedical Advanced Research and Development Authority...READ MORE
- Pfizer’s Early Data Shows Vaccine Is More Than 90% Effective (nytimes.com)After Pfizer's vaccine data, analysts say COVID19 drugmakers face questions about long-term sales prospects (fiercepharma.com)Pfizer/BioNTech Candidate COVID-19 Vaccine Report More Than 90% Efficacy, But Details Sparse (pharmacypracticenews.com)
Pfizer announced positive early results from its coronavirus vaccine trial, cementing the lead in a frenzied global race that has unfolded at record-breaking speed...Pfizer, which developed the vaccine with the German drugmaker BioNTech, released only sparse details from its clinical trial, based on the first formal review of the data by an outside panel of experts...The company said that the analysis found that the vaccine was more than 90 percent effective in preventing the disease among trial volunteers who had no evidence of prior coronavirus infection. If the results hold up, that level of protection would put it on par with highly effective childhood vaccines for diseases such as measles. No serious safety concerns have been observed, the company said...READ MORE
- CVS pushing for pharmacy technicians to be able to administer COVID-19 vaccines (fiercehealthcare.com)CVS Health to hire 15,000 across the U.S. in fourth quarter (cvshealth.com)CVS to add 1K rapid-result COVID-19 test sites at pharmacies (fiercehealthcare.com)
CVS Health is pushing for pharmacy technicians to be allowed to administer COVID-19 vaccines...The healthcare giant is hiring more than 10,000 full- and part-time pharmacy technicians in Q4 in anticipation of flu season, and urging for them to have an expanded scope of practice that would allow them to vaccinate patients for the novel coronavirus under supervision from an immunization-certified pharmacist...CVS said that allowing technicians to administer vaccines would "help fill the urgent need to safely and quickly scale distribution of a vaccine and extend the capacity of the health care workforce to address the pandemic."...READ MORE
- When will COVID-19 vaccines be widely available? Feds lay out an ambitious timeline (fiercepharma.com)
With Moderna and Pfizer both reporting sky-high response rates to their COVID-19 vaccines, the pressure is on federal health officials to ensure a rapid—but smooth—rollout. Wednesday, they unveiled a detailed timeline that provides some clues about when most Americans can expect to be vaccinated...High-priority populations such as healthcare workers and nursing home residents could obtain COVID-19 vaccines in December...The key to distributing the vaccines to older Americans quickly is a distribution deal the government struck with Walgreens and CVS last month. Last week, more agreements were formed with pharmacy chains and independent pharmacies...Warp Speed has been fostering the development of six additional COVID-19 vaccines...Moderna expects to ship 20 million doses for use in the U.S. by the end of this year and up to 1 billion worldwide next year. Pfizer is gearing up to ship 50 million doses this year...READ MORE
- Lucky Pfizer CEO Bourla cashes out $5.6M worth of stock—perfectly legally—as COVID vaccine data lifts market (fiercepharma.com)
On Monday before the stock market opened, Pfizer announced that its COVID-19 mRNA vaccine had proven 90% effective so far in its ongoing late-stage trial, lifting the company’s shares nearly 8% through the course of the day...The same day, in a stock sale Pfizer says was planned months ago, CEO Albert Bourla offloaded 132,508 shares—more than 60% of his total holdings—for $5.6 million...Insider trading? Nope. Extraordinarily lucky? To be sure. And no doubt the size and timing of this sale, coupled with Bourla's confidence over the last few months leading to Monday's data announcement, are enough to rile up critics of executive pay packages in Big Pharma...READ MORE
- Sanofi, SK flu shots halted in Singapore as South Korea post-vaccination deaths climb to 59 (fiercepharma.com)
Deaths after flu vaccination keep rising in South Korea. But as local health authorities work to calm concerned citizens by refuting a connection between the two, a fellow Asian country has taken the precautionary measure of suspending two shots given to people who later died...Singapore has temporarily pulled its backing for SK Bioscience’s SKYCellflu Quadrivalent and Sanofi Pasteur’s VaxigripTetra, the Ministry of Health said...READ MORE
- EMA Starts Rolling Review of Moderna’s COVID-19 Vaccine Candidate (biopharminternational.com)
Moderna reported...that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has started a rolling review of mRNA-1273...CHMP’s decision to commence the rolling review of data on mRNA-1273 has been based on the preliminary results from non-clinical and early clinical studies, which have suggested the vaccine has an efficacy of 94.5%. The rolling review will be performed by the committee until there is sufficient data to support a formal marketing authorization application...READ MORE
- Brazil health regulator suspends Chinese-made vaccine trials (apnews.com)
Brazil’s health regulator halted clinical trials of the potential coronavirus vaccine CoronaVac, citing an “adverse, serious event,” according to a statement it posted to its website Monday night...The potential vaccine is being developed by Chinese biopharmaceutical firm Sinovac and in Brazil would be mostly produced by Sao Paulo’s state-run Butantan Institute. Butantan said in a statement that it was surprised by Anvisa’s decision and that it would hold a news conference Tuesday...The CoronaVac shot has stirred controversy in Brazil, where President Jair Bolsonaro has cast doubt on its prospective effectiveness. He sparked confusion last month when he publicly rejected it, saying Brazilians would not be used as guinea pigs. The declaration followed news that his health minister, Eduardo Pazuello, had agreed to purchase CoronaVac doses produced locally by Butantan...READ MORE
- Takeda, Moderna partner up to bring 50M coronavirus shots to Japan (fiercepharma.com)
Japanese drugmaker Takeda has quickly emerged as one of the leading forces in the fight against COVID-19 as a vaccine manufacturing partner and R&D lead on a convalescent plasma-based therapy. Now, Takeda will help another biotech distribute its potential COVID-19 vaccine in the drugmaker's home country...Moderna has tapped Takeda to bring 50 million doses of its mRNA-based COVID-19 shots to Japanese shores as part of a government-backed vaccine distribution effort...Takeda will import and distribute Moderna's shot, dubbed mRNA-1273, starting in the first half of next year, as well as handle local regulatory approvals...READ MORE