For all of the varied work on COVID-19 vaccine candidates, the majority of vaccines to win emergency use authorization have fallen into a handful of categories, including mRNA, viral vector and inactivated vaccines. Zydus Cadila (NSE: CADILAHC) is adding more diversity to the pool with its ZyCoV-D vaccine, which recently received emergency use authorization (EUA)…
FDA approves Pfizer-BioNTech COVID-19 vaccine
The FDA today issued approval for Pfizer and BioNTech’s COVID-19 vaccine, making it the first to receive full approval in the U.S. The approval covers the prevention of COVID-19 in individuals 16 years of age and older. The vaccine remains available under FDA emergency use authorization (EUA) for people who are 12 years of age…
CDC advisory committee recommends additional vaccine dose for immunocompromised
The panel joined FDA in endorsing a third dose of Pfizer-BioNTech and Moderna vaccines for moderately to severely immunocompromised patients. The Advisory Committee on Immunization Practices (ACIP) concluded there was insufficient evidence to recommend an additional dose for immunocompromised recipients of Janssen’s COVID-19 vaccine. The ACIP panel described the third dose of vaccine as part…
FDA allows Pfizer-BioNTech and Moderna boosters in the immunocompromised
The FDA has authorized boosters for certain vaccinated individuals, but the agency believes there is insufficient evidence to recommend boosters to the broader population. The amended EUA applies to the Pfizer-BioNTech or Moderna vaccines. The individuals covered in the EUA include solid organ transplant recipients and people with other medical conditions leading to a moderate…
WHO to test three anti-inflammatory therapies in COVID-19 patients
The World Health Organization (WHO) is adding three anti-inflammatory therapies to its global Solidarity COVID-19 trial. WHO is referring to the expanded trial as “Solidarity PLUS.” WHO will investigate the following drugs as potential treatments for hospitalized COVID-19 patients: Ipca Laboratories’ artesunate is an FDA-indicated treatment for severe malaria in adult and pediatric patients. Last year,…
Prominent COVID-19 vaccine makers continue to make case for boosters
The case for boosters has gained ground amidst the surge in COVID-19 infections over the past month. BioNTech CEO Özlem Türeci recently recommended that health officials administer a third dose six to 12 months after the second dose to “maintain the highest level of protection.” Pfizer CEO Dr. Albert Bourla has made similar recommendations. Pfizer…
COVID-19 vaccines driving a decoupling between infections and deaths
In the U.S., areas with low vaccination rates have seen an uptick in vaccinations, while authorities in many highly-vaccinated areas have recommended mask-wearing and similar COVID-19 policies. While Delta has blunted COVID-19 vaccines’ ability to reduce transmission, vaccines remain effective at saving lives. During the peak of the prior wave, thousands of people died daily…
Study finds mild short-term impact from myocarditis after COVID-19 vaccination
Despite the rare risk of myocarditis in children, the benefits of the Pfizer-BioNTech BNT162b2 vaccine likely outweigh the risks, according to a recent JAMA Cardiology report. A separate pre-print study found that adolescents’ risk of contracting myocarditis is substantially higher after contracting COVID-19 than from receiving mRNA vaccines targeting the novel coronavirus. An earlier JAMA…
COVID-19 vaccination halves reinfection risk according to CDC study
Among those with previous COVID-19 infections, those who were unvaccinated were 2.34 times more likely to get infected again than vaccinated individuals, according to a CDC report. “Getting the vaccine is the best way to protect yourself and others around you, especially as the more contagious Delta variant spreads around the country,” said CDC director Dr.…
U.S. government withholds funding from Novavax
Although Novavax (NSDQ:NVAX) disclosed the news in a July 31 SEC filing, investors apparently didn’t react to the development until today. In mid-day trading, the stock dipped 20% to $188.18. The company’s stock had surged earlier in the week. In the SEC filing, Novavax said the U.S. government told the company to align its analytic methods…
How Delta could change the COVID-19 landscape
Delta is “an extremely transmissible variant and has taken us all for a loop,” said Dr. Monica Gandhi, a professor of medicine and associate division chief of the division of HIV, infectious diseases and global medicine at University of California, San Francisco. But despite Delta’s hurricane-like ascent, the volume of infections it drives are likely…
Novavax stock surges after striking EU COVID-19 vaccine deal
Novavax (NSDQ:NVAX) saw its stock jump more than 20% in afternoon trading after the European Commission agreed to purchase up to 200 million doses of its vaccine. The Gaithersburg, Md.–based vaccine maker announced in March that its NVX-CoV2373 vaccine was 96.4% effective against the original SARS-CoV-2 strain in a U.K. trial. The efficacy in a later trial…
FDA responds to pressure to approve COVID-19 vaccines
Health experts have insisted that the FDA accelerate the approval process for COVID-19 vaccines, starting with the Pfizer-BioNTech vaccine. The agency will reportedly begin a “sprint” initiative to accelerate its approval of that vaccine, which was the first to win emergency use authorization, according to multiple media outlets, including The Wall Street Journal. Media reports…
Pfizer highlights COVID-19 and flu vaccine strategy in Q2 earnings call
With vaccines generating a significant portion of Pfizer’s (NYSE:PFE) revenue in the first six months of 2021, the company shed light on its vaccine plans in its most recent quarterly earnings call. While the company recently won FDA approval for its potential blockbuster pneumococcal 20-valent vaccine, its mRNA vaccine strategy understandably took center stage during…
Preprint shows strong but fading efficacy of Pfizer vaccine at six months
An ongoing study involving the BNT162b2 COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) could potentially underscore the need for boosters. But more data are needed to understand vaccine performance over time, according to a preprint published on MedRxiv. Pfizer CEO Dr. Albert Bourla has previously predicted that booster doses of the vaccine would be needed. Still,…
Pfizer and Moderna to expand clinical trials for school-aged children
As a result, Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) have agreed to expand clinical trials of their vaccines in children aged five to 11 before seeking emergency use authorization. In April, Israel first reported suspected cases of heart inflammation in recipients of the COVID-19 vaccine from Pfizer and its partner BioNTech. Since then, FDA has substantiated the risk of myocarditis,…
AstraZeneca, Pfizer Moderna vaccines fare well against Beta, Gamma and Delta variants in study
A recent Canadian pre-print study found that AstraZeneca’s Vaxzevria vaccine was 82% effective in preventing hospitalization or death from the Beta and Gamma SARS-CoV-2 virus variants. Using the same benchmark, its efficacy against the Alpha and Delta variants was 87% and 90%, respectively, 21 days after administering the first dose. The BNT162b2 vaccine from Pfizer and BioNTech…
Man experiences facial palsy twice after receiving both COVID-19 vaccine doses
The possibility of mRNA causing facial palsy continues to make headlines. A month after a JAMA study found no link between the Pfizer-BioNTech vaccine and facial paralysis, an article in BMJ Case Reports describes the case of a 61-year-old U.K. man who experienced facial palsy episodes after receiving both doses of the Pfizer-BioNTech vaccine. The journal reports that…
Mix-and-match COVID vaccines attract support and backlash
Several countries have embraced the idea of using distinct COVID-19 vaccines for the first and second doses. But a death in Korea is fueling concerns about the strategy, and some public authorities have warned against the practice. Canada, Korea, Thailand and Germany have authorized the use of a heterologous prime-boost COVID-19 vaccination strategy to manage…
FDA links J&J vaccine to rare cases of Guillain–Barré
The Food and Drug Administration has concluded that the COVID-19 vaccine from Johnson & Johnson’s (NYSE:JNJ) could rarely cause Guillain–Barré syndrome in which the immune system attacks the nervous system. A warning is forthcoming, according to media reports. Researchers have also linked prior vaccines, including a swine flu vaccine introduced in the 1970s, with the syndrome, which destroys…
Why Bioclinica tapped AI in immunotherapy trials early in the pandemic
An AI-based system proved its mettle in screening patients in immunotherapy trials, according to Dan Gebow, chief innovation officer at Bioclinica. Early in the COVID-19 pandemic, developers of cancer immunotherapies worried that the novel coronavirus would interfere with their clinical trial results. In previous years, the scientific community established that immunotherapy can rarely cause interstitial…
Pfizer to ask FDA to authorize booster dose of its COVID-19 vaccine
Pfizer (NYSE:PFE) has said that the efficacy of its vaccine wanes after six months in the presence of contagious variants such as Delta. The company and its German partner plan on using that justification to ask FDA to extend their EUA for their COVID-19 vaccine to cover a booster dose of their mRNA vaccine. Reuters quoted…
Several companies could vie for next-gen COVID-19 vaccine market share
A couple of years ago, mRNA vaccines remained at the research stage. Now, they are among the best-selling pharmaceutical products with Pfizer (NYSE:PFE), BioNTech (NSDQ:BNTX) and Moderna (NSDQ:MRNA) dominating the market. However, that could change in the long run as a growing number of companies develop next-generation mRNA COVID-19 vaccines, which promise to be more effective…
APC debuts ‘medicine accelerator’ in collaboration with Enterprise Ireland
The Dublin-based pharmaceutical R&D firm APC Ltd has launched a ‘Global Centre of Excellence for Vaccine and Advanced Therapeutic Research and Manufacturing.’ The result of a €25 million investment, the new facility will staff 120 new employees. The facility will have the capacity to produce hundreds of millions of doses of vaccines (including for COVID-19)…
Pfizer to seek to expand COVID-19 vaccine EUA to children aged 5 to 11
Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) aim to expand the U.S. emergency use authorization (EUA) for their COVID-19 vaccine to include children aged five to 11. The companies plan on filing paperwork for the expanded EUA over the coming months. “We are planning for emergency use authorization submission for [children aged five to 11] in…