After a few early delays and obstacles, Johnson & Johnson developed and began producing a stable, one-shot COVID-19 vaccine, and even a recent mishap at a contract manufacturing facility highlights the resilience of a system that relies on "precise orchestration of timing, engineering, and logistical expertise across multiple continents," writes Jeff Wise. The story of the vaccine's development is one of collaboration, years of prior research, public-private partnership, innovative engineering and supply chain flexibility.
The EU is expected to finalize GMP Annex 1 this year, including provisions related to isolator design and operation. The draft document covers criteria for surface decontamination, automation and containment of highly active and dangerous substances, writes Richard Denk, a senior consultant for aseptic processing and containment at SKAN and a member of the ISPE team commenting on the draft annex.
Government authorities and health care leaders discussed regulations and best practices for drug registration and approval in Persian Gulf states during the recent Gulf Cooperation Council Regulatory Affairs Pharma Summit. The COVID-19 pandemic has "underscored the importance of optimizing market access for pharmaceuticals and simplifying drug registration and approvals," said Najiba Al Shezawy, managing director at conference organizer PRA Consultancy.
The last links in the COVID-19 vaccine supply chain -- that is, the people administering shots -- are taking snowmobiles, small planes, fishing boats, camels, horses and elephants to reach the most remote parts of the globe, where they are often greeted with some skepticism as well as gratitude and jubilation. "We are so thrilled. This will provide relief from the level of isolation that we're unaccustomed to out here," said Lindsay Eysnogle, a teacher on Maine's remote Little Cranberry Island.
A small study in the American Journal of Obstetrics and Gynecology found that pregnant women who had received either the Moderna or Pfizer/BioNTech vaccine in their third trimester had a strong immune response after vaccination, indicating that the vaccines protect pregnant women against COVID-19, and that a longer time between vaccination and delivery was linked to greater transfer of COVID-19 antibodies to the baby. The findings, based on data from 27 pregnant women and their babies, also showed that mothers who received a second dose of the two-dose vaccines prior to delivery were more likely to transfer COVID-19 antibodies to their infants.
Sen. Joe Manchin, D-W.Va., is asking the CDC for a congressional investigation into Kanawha County's high rate of HIV cases. The county has had 51 newly diagnosed cases of HIV since January 2019, with 35 of those reported in 2020.
Biopharmaceutical manufacturers need to start building flexibility, redundancy and personal connections into supply chains to address vulnerabilities laid bare by the pandemic, writes Charles Cooney, a professor emeritus and instructor of a course on downstream processing at MIT. Machine learning and artificial intelligence can improve supply chain management as well as workforce health and safety, implementation of new bioprocessing modalities and process resilience, Cooney writes.
Brazilian health officials are looking to veterinary vaccine manufacturing facilities to increase the COVID-19 vaccine supply in Brazil and neighboring countries, says Health Minister Marcelo Queiroga. Brazilian President Jair Bolsonaro also asked the US to send spare doses.
India exports $25 billion worth of pharmaceutical products to 206 countries every year, but rising prices on active pharmaceutical ingredients from China, delayed opening of new pharma parks and an unfavorable tax policy threaten the nation's dominance, says Dinesh Dua, former chairman of the CII Committee of Lifesciences & Biotech, Northern Region. Dua says China raised prices in retaliation for productivity linked incentives, but PLIs have been of no benefit because pharma parks with shared effluent treatment plants, laboratories and other infrastructure have not been built.
Hungary's National Institute of Pharmacy and Nutrition certified that Sinopharm's COVID-19 vaccine meets good manufacturing practice standards, which may encourage other EU member states to authorize use of the vaccine.