US FDA recommends change to COVID-19 vaccine composition

Food and Drug Administration building is shown Thursday, Dec 10, 2020 in Silver Spring, Md. (MANUEL BALCE CENETA / AP)

BELGRADE / MEXICO CITY – Advisers to the US Food and Drug Administration on Tuesday recommended a change in the design of COVID-19 booster shots this fall in order to combat more recently circulating variants of the coronavirus.

The FDA's Vaccines and Related Biological Products Advisory Committee voted 19-2 that the next wave of COVID booster shots should include a component that targets the Omicron variant of the coronavirus.

The FDA plans to decide by early July on what the design of the boosters should be.

Pfizer Inc, Moderna Inc and Novavax Inc presented data at the meeting. All three companies have been testing versions of their vaccines updated to combat the BA.1 Omicron variant

FDA scientists at the meeting suggested they preferred vaccines that will target the BA.4 and BA.5 Omicron subvariants that are currently dominant rather than the BA.1 Omicron variant that led to a massive surge in infections last winter.

Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said the regulator would hope to launch a booster campaign with a retooled vaccine by October.

"The better the match of the vaccines to the circulating strain we believe may correspond to improved vaccine effectiveness, and potentially to a better durability of protection," Marks told the meeting of outside expert advisers to the agency.

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Pfizer Inc, Moderna Inc and Novavax Inc presented data at the meeting. All three companies have been testing versions of their vaccines updated to combat the BA.1 Omicron variant.

Moderna said it would be ready with a "couple of hundred million" of bivalent, or double targeted, vaccines designed to combat BA.1 by September. It would be late October or early November if it needs to design a vaccine targeting the newer subvariants, the company said.

Pfizer said that it and partner BioNTech already has a significant amount of BA.1 vaccine ready and is preparing to produce a large amount of vaccine targeting BA.4 and BA.5. It said either could be ready for an early October rollout.

Dr. Kanta Subbarao, representing a World Health Organization advisory committee that also considered the issue, said she preferred BA.1-based vaccines, suggesting they could generate a broader immune response because that variant is more distinct from the original virus than its successor subvariants.

"Our goal here is to achieve broader immunity against circulating and emerging variants," Subbarao said, noting that trying to match what variant might be circulating in the fall is difficult because of uncertainty about the trajectory of the evolution of the virus.

A woman receives her first dose of the AstraZeneca vaccine against COVID-19 in Mexico City on August 10, 2021.
(ALFREDO ESTRELLA / AFP)

Mexico

Mexico has seen 10 weeks of increase in COVID-19 cases though the hospital admission rate remains low, the Undersecretary of Prevention and Health Promotion Hugo Lopez-Gatell said Tuesday.

Deaths from the pandemic are also increasing at a slower pace compared to the past waves of outbreaks, said the Mexican official.

"Fortunately, hospitalizations are rising very little," Lopez-Gatell told reporters at the National Palace in Mexico City.

Hospital occupancy due to COVID-19 accounts for 6 percent of total hospital admissions, according to official data.

Deaths have risen to an average of seven a day in recent weeks, up from an average of five, the official said.

Mexico registered its first case of COVID-19 at the end of February 2020, and logged 5,965,958 confirmed cases of the disease and 325,596 deaths as of June 27.

A Bosnian citizen takes a selfie picture while receiving a dose of the AstraZeneca Covid-19 vaccine at one of Belgrade's vaccination centre, on March 28, 2021. The small Balkan country has so many vaccines available it has even offered jabs to any foreigner who can get themself there, sparking an influx of thousands of "vaccine tourists" from neighbouring countries. (OLIVER BUNIC / AFP)

Serbia

A total of 810 new COVID-19 cases were registered in Serbia, the highest in two months, said the Institute of Public Health of Serbia on Tuesday.

The new cases account for almost 10 percent of 8,341 people who were tested, said the institute.

Milanko Sekler, a virologist from a veterinary institute in the city of Kraljevo, warned of an increasing trend of new infections in Serbia as well as in neighboring countries and the European Union (EU), according to public broadcaster RTS.

source https://eastmud.com/latest-news/us-fda-recommends-change-to-covid-19-vaccine-composition/