Covid-19 roundup: Biden now plans boosters after 6 months as Pfizer submits sBLA; 1.6M Moderna doses contaminated in Japan — reports
Reports surfaced earlier this month that President Joe Biden’s administration was preparing to announce a booster shot plan calling for third doses to be administered eight months after an individual’s second shot. Those plans, however, have reportedly changed.
The new plan from federal regulators will now call for a booster shot six months following the second mRNA dose, the Wall Street Journal reported Wednesday, given that data from vaccine makers and other countries are based on six-month follow-ups. An unnamed official told WSJ that approval for all three OK’ed shots will likely come in mid-September.
Wednesday’s report came as Pfizer and BioNTech submitted a supplemental BLA for booster shots earlier in the day, handing data to the FDA from a 306-person Phase III study. In the trial, participants were given a third vaccine dose between 4.8 and 8 months after their second shot, with Pfizer saying the booster elicited “robust” antibodies to the original strain at least one month after the third shot in those without a confirmed Covid-19 case.
Additionally, 50% neutralizing titers were more than 3.3 times higher one month after the third dose compared to the same time period following the second shot, Pfizer said. Data are expected to be submitted to a peer-reviewed journal in the coming weeks.
After receiving full approval for the two-dose regimen on Monday, Pfizer is rolling right along with its booster plans, and is ahead of the pack in this regard. Moderna only submitted its BLA for its vaccine earlier this week, while J&J hasn’t yet sought approval for its one-dose vaccine.
The new booster plan and sBLA come a week after federal officials recommended a booster shot for adults who had received a two-dose mRNA vaccine beginning in September. J&J, sporting an adenovirus approach, also gave a first look at its own booster data Wednesday, saying the extra shot prompted a nine-fold antibody increase 28 days after the first shot.
Some experts criticized the data, however, as it only came from an analysis of 20 patients. Scripps Research Foundation founder Eric Topol called for a deeper look into the data on Twitter, asking to see results from J&J’s two-dose vaccine trial.
Moderna, Takeda forced to withdraw 1.6M doses after contamination reports
The Japanese government has taken about 1.6 million doses of Moderna’s Covid-19 vaccine out of use after reports of contamination arose around the country, Nikkei Asia reported Wednesday.
Vaccination centers in Japan began noticing foreign materials in vials that reacted to magnets, driving speculation the contaminants could have been metal, per a government official. According to a separate Reuters report, the first contamination reports began coming in on August 16 when Takeda, which distributes the Moderna vaccine in Japan, became aware.
Takeda waited until Wednesday to alert the government because it needed time to figure out which vials had been botched and where they had been distributed, officials told Reuters.
The Japanese defense ministry also said shots from the contaminated batch had been used at a mass vaccination site in Osaka between August 6 and August 20, but did not disclose to Reuters how many people had been affected. So far, there have been no reported health issues related to the contaminated shots, and other batches of the Moderna shot have not been paused.
Moderna and Japan both said there were no safety or efficacy issues related to the reports, and that taking the vials out of circulation is a precautionary measure. Two lots adjacent to the contaminated batch have also been put on hold. It is believed a manufacturing issue at a plant in Spain caused the contamination, Moderna told the outlets.
The Cambridge, MA-based biotech received emergency authorization in Japan in May. Japan has been battling its worst surge of the pandemic due to the highly contagious Delta variant, topping 25,000 cases per day this month. Currently, 54% of Japan’s population has received one dose and 43% have been fully vaccinated. Prime minister Yoshihide Suga is aiming to have about 60% of the country’s population fully vaccinated by the end of September.
Biden urged to reject Brazil bill scrapping IP protections
After supporting a World Trade Organization proposal to waive vaccine IP earlier this year, the Biden administration is being urged to speak out against a new bill proposed by Brazil that would allow patents to be waived in case of medical emergencies.
The Intellectual Property Owners Association sent a letter to Biden officials asking for their support, Law360 reported Wednesday. Should the bill become law in Brazil, the country’s government would have the authority to break the patents without approval from the executive branch.
Brazil’s lower house of Congress approved a draft of the bill at the beginning of July, per a Reuters report from the time.
The WTO proposal earlier this year came from India and South Africa, with the countries arguing waiving patents would help lower- and middle-income countries get better access to shots and Covid-19 treatments. The US position had originally been to oppose the measure, but Biden came out in support in May.
That reversal prompted significant pushback from pharma industry groups who argued waiving IP wouldn’t do much by way of providing access. Michelle McMurry-Heath, president and CEO of lobbying group BIO, said at the time, “Handing needy countries a recipe book without the ingredients, safeguards, and sizable workforce needed will not help people waiting for the vaccine.”