• Harvard University posts a pre-print article detailing costs for generic mass production of Merck’s experimental COVID-19 antiviral treatment, molnupiravir. Using methodology including the cost of active pharmaceutical ingredients, excipients, and production, as well as the profit margin – and taxes on it – they estimate that a five-day treatment course of four 200 mg molnupiravir capsules twice daily could be profitably and sustainably mass- produced for $19.99, or just under $2.00 per capsule. The authors noted that the US has already ordered 1.7 million treatment courses, at about $700 each, a price they describe as “…equal to about 35 times the estimated sustainable generic price using current market prices for the active ingredient (API) observed in our analysis,“ noting that “…optimization of molnupiravir synthesis, and a resulting drop in API cost, the US price would be equal to about 161 times the estimated sustainable generic price.” Source

• Merck and its development partner, Ridgeback Biotherapeutics, issue a press release with interim data from the phase III MOVe-OUT trial in at risk, unvaccinated and non-hospitalized adults with mild-to-moderate COVID-19.  In their analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50 percent: 7.3 percent of patients (28/385) who received molnupiravir were either hospitalized or died through Day 29, versus 14.1 percent of of placebo-treated patients (53/377). Through Day 29, there were no deaths among molnupiravir recipients, as compared to eight deaths among patients who received placebo. After a recommendation from the study’s independent Data Monitoring Committee, and in consultation with the US FDA, study recruitment is being stopped early due to these positive results. Merck plans to submit an application for Emergency Use Authorization to the FDA as soon as possible, and to other regulatory bodies worldwide. Source

• Australia’s Prime Minister, Scott Morrison, announced that international travel bans will be lifted in November, allowing states that have vaccinated 80 percent of their residents to welcome vaccinated visitors from overseas. Source

• A spike in coronavirus cases – and a COVID-19 death rate that surpassed malaria-related mortality for the first time – leads Angola to close beaches and other leisure and public-gathering facilities just a month after they opened. As of 15 October, access to public services will be limited to people who have proof of vaccination or a negative test result, and coronavirus vaccination will be required for nearly all citizens 18 years or older, including pregnant women. Angola recorded 14,549 infections and 558 deaths during September. Source

• China has given local authorities until the end of October to build or convert existing structures into specialized quarantine facilities with 20 rooms per 10,000 residents to accommodate thousands of overseas visitors. Source

Kaiser Health News reports that the US death rate from COVID-19 has shifted from the cities where the pandemic first struck to rural areas, where it is over twice as high than that in urban areas. versus urban areas. Even before the pandemic, there were disparities; overall death rates among people in rural areas were 20 higher than those among people in urban areas.

Health experts say that rural populations are less likely to be insured, have less access to medical care and lower vaccination rates (as of 23 September, 41 percent of rural America was vaccinated versus 53 percent of urban America); they tend to be older, sicker, poorer and weigh more than their urban counterparts. In addition, the volume of COVID patients has worsened healthcare access for people with other illnesses who cannot be transferred to regional or urban health centers. Source

• Takeda announces that human error was responsible for stainless-steel contaminated Moderna vaccines, leading to the suspension of 1.6 million doses in Japan. The vaccines were produced by Spain’s Laboratorios Farmacéuticos Rovi, who noticed the contamination – although they were permitted to export the vaccines to Japan. Moderna, Takeda and Rovi collaborated on an investigation which found that the contamination was caused by misjudging a required 1 mm gap between the star-wheel and the stopper of machinery. Five lots manufactured between June 27 and July were investigated; stainless steel was found inside of 39 vials in the first three lots, and a fourth and fifth lot failed inspection and were held back by Rovi.

In August, two men in Japan died within days of receiving their second vaccine, which belonged to one of the three recalled lots; their deaths are being investigated. Source

• A press release announced results from The University of Bristol’s 679-person, randomized, controlled Combining Influenza and COVID-19 Vaccination (ComFluCOV) study, which looked at the safety of co-administering the two most widely used COVID-19 vaccines with the three most commonly-used influenza vaccines, describing immune responses to, and side effects from the co-administered vaccines. The researchers reported that immune responses to both vaccines were preserved; the most common side effects were mostly mild-to-moderate injection site pain and fatigue, although 97 percent of participants said they would be willing to receive two vaccines at the same time in the future. Source

• Daily COVID-19 cases in South Korea (mainly among the unvaccinated) and Singapore (where 82 percent of residents are fully vaccinated) are rising to all-time highs, leading to new restrictions in both countries. Source

• Britain’s government loosened quarantine regulations –except for visitors from India fully vaccinated with Covishield, a version of the Oxford/AstraZeneca vaccine produced under license by India’s Serum Institute. India’s foreign secretary, Harsh Vardhan Shringla called it a “discriminatory” move, noting that India had provided five million doses of Covishield to Britain when it was struggling with its vaccination campaign. In response, India announced that British visitors will need results from a PCR test for COVID-19 before their flight, undergo tests on arrival and after eight days, and remain in quarantine for 10 days – regardless of their vaccination status, in reciprocity, until Britain’s policy changes. Source

• In Romania, which is home to Europe’s second-lowest vaccination rate and a record-breaking number of new coronavirus cases, a fire in the intensive care unit of a hospital where COVID-19 patients were being treated killed at least seven people. Although the cause is currently under investigation, officials said that oxygen had been turned off, raising the possibility that it may have had a role in the blaze, since oxygen tanks have been blamed for deadly fires at coronavirus clinics around the world, most recently killing 14 people in North Macedonia.

The country’s President, Klaus Iohannis, described the fire as “a terrible new drama that confirms the deficient infrastructure of the Romanian health system,” which he said was outdated and “…long strained and put under unimaginable pressure by the fourth wave of the COVID-19 pandemic.” Source

Nature Medicine publishes a study comparing immune responses to the Pfizer/BioNtech coronavirus vaccine among 53 people undergoing chemotherapy for solid tumors to 50 people without cancer. After noting significantly diminished immune responses, particularly for neutralizing antibodies (although most mounted T cell responses) the researchers conducted a phase I trial of a third booster dose looking at safety and immune responses among 20 of the people undergoing treatment for active cancer. A week after the booster, blood samples revealed an increase in neutralizing antibodies, but no overall increase in T cells; adverse events were mild. The researchers noted that “…these data suggest that vaccination might confer at least partial protection and reduce the likelihood of severe COVID-19 in most patients with cancer.” Source

Quartz reports that Merck’s experimental COVID-19 antiviral, molnupiravir, could be one of the most lucrative drugs ever. Although the drug has not been approved – and the phase III trial is ongoing – the US government already agreed to buy 1.7 million treatment courses for $700 each, reaching a total of $1.2 billion. Merck has agreements with other governments, but it has not shared details beyond that pricing will be determined by national income levels (a strategy called tiered pricing), and that it has plans to issue a voluntary license with Indian generics manufacturers for low-income markets.

Currently, Merck plans to produce 10 million treatment courses before the end of 2021, for which revenues could reach $7 billion. Given that there are nearly 500,000 new cases of COVID-19 each week, the market for molnupiravir could quickly exceed Merck’s production capacity. Source

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