Covid-19 roundup: India to resume vaccine exports as its own campaign is under control; Pfizer to file for vaccine OK in children ages 5-11
After vaccine exports were halted to focus on providing its own people with enough doses, India will begin shipping its Covid-19 vaccines to the Covax program again, the health minister said Monday.
In April, the country halted shipments as it faced a brutal wave of the pandemic, which saw daily case numbers skyrocket from around 25,000 in mid-March to more than 400,000 a day by May. Since then, however, the vaccine output has more than doubled, and minister Mansukh Mandaviya said that it is set to quadruple to more than 300 million doses in October. Only the excess supply will be sent to Covax, he said.
Prime Minister Narendra Modi is in Washington this week, as vaccines will likely be discussed at a summit that features the US, India, Japan and Australia. He has a goal of vaccinating everyone in India, about 944 million people, by December. About 64% of people in India have received at least one dose of the jab so far, while 22% are fully vaccinated.
The Serum Institute of India announced in July that the final batch of Novavax’s vaccine had been produced, and the company manufactured AstraZeneca’s jab at its Pune, Maharashtra site as well. Novavax went on record to say that some 350 million would be set to be shipped by Q3.
Companies in India have the capacity to produce almost 3 billion Covid-19 vaccines a year, the Arab News reported. The country sold or donated nearly 66 million doses before the export halt in April.
Pfizer to file for vaccine OK in children ages 5-11
Just a day after NIH director Francis Collins said on Fox News Sunday that a timeline for when children ages 5-11 can be vaccinated should be coming in the next few weeks, Pfizer and BioNTech announced that their Covid-19 vaccine is safe and induces antibody responses to the virus in that age group.
Children were given two 10 µg doses three weeks apart, which generated a comparable response to participants who received 30 µg in a study of the vaccine ages 16 to 25. The results are the first to come from a study of this age group.
Pfizer CEO Albert Bourla said in a press release:
Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our Covid-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children. Since July, pediatric cases of Covid-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.
Results for children under the age of 5 are expected later this year, Pfizer said.
The data comes from a Phase II/III study of children 6 months old to 11 years old, 2,268 of which were between the ages of 5 and 11. Children under the age of 5 received a 3 µg dose for each injection. Side effects experienced were similar to those felt by adults, the press release said.
“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” BioNTech CEO Ugur Sahin said in the press release. “The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.”
The two companies expect the data to be included in a near-term submission for emergency use authorization with the FDA and a request to update the EMA’s conditional market authorization.
Since the pandemic began, children have accounted for more than 15% of the total Covid-19 cases in the US. As of the week of Sept. 9, children represented nearly 30% of all weekly cases, while making up just 22% of the population. Severe illness is uncommon, but the long-term impacts on children are still not entirely known.
US booster data coming in weeks — Fauci
The US is weeks away from releasing data surrounding the need for booster shots of Moderna and J&J’s Covid-19 vaccine, Anthony Fauci said in an interview with CNN Sunday.
While he said boosters are expected to be needed, Fauci encouraged Americans not to get the third shot until after the FDA has given approval. On Friday an FDA advisory panel recommended a third shot of the Pfizer/BioNTech jab for those above the age of 65, or at risk of a severe case of the virus, but not the entire population.
The US tops the global list of reported Covid-19 cases and deaths. Almost 675,000 people have died during the pandemic, and there have been more than 42 million cases. In August, President Joe Biden’s administration announced his intent to roll out a booster plan for Americans 16 and older. Fauci said Sunday that the FDA’s decision doesn’t negate that stance supporting boosters.
A chaotic FDA adcomm meeting last Friday ended with a rejection of the Pfizer/BioNTech jab for all people above the age of 16 by a 16-2 vote, though the amended recommendation passed unanimously. Adcomm members also noted that they’d be open to recommending boosters for smaller, high-risk populations.
Two members — Marion Gruber and Philip Krause — announced their intention to resign last month after raising concerns with boosters in the Lancet.