Pfizer and BioNTech seek FDA emergency use authorization for updated COVID-19 vaccine booster



Pfizer and BioNTech have asked the U.S. Food and Drug Administration to green-light emergency use authorization for an updated COVID-19 vaccine booster shot.

According to a press release, the companies are seeking an EUA for "a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older."

"The bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein, which is present in the original Pfizer-BioNTech COVID-19 Vaccine, together with mRNA encoding the spike protein of the Omicron BA.4/BA.5 variant," the press release said. "Pre-clinical data showed a booster dose of Pfizer and BioNTech's Omicron BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain. A clinical study investigating the safety, tolerability and immunogenicity of the Omicron BA.4/BA.5-adapted bivalent vaccine in individuals 12 years of age and older is expected to start this month."

The booster is set to roll out immediately once the green light is given.

"The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed," Pfizer chairman and CEO Albert Bourla said, according to the release. "Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges."

Prominent figures, including Bourla, have tested positive for COVID-19 after having already received four vaccine shots.

"After isolating all week, I am happy to report that I have now tested negative in 2 consecutive tests. Although I was fortunate to only experience mild symptoms that resolved within a few days, I am grateful for the support and well wishes expressed by so many," Bourla tweeted on Friday.

\u201cAfter isolating all week, I am happy to report that I have now tested negative in 2 consecutive tests. Although I was fortunate to only experience mild symptoms that resolved within a few days, I am grateful for the support and well wishes expressed by so many.\u201d
— Albert Bourla (@Albert Bourla) 1660935237

Shanghai begins phased lockdown as COVID surges in China's largest city



Shanghai has begun a phased COVID-19 lockdown, as China’s largest financial hub grapples with a massive surge in cases of the Omicron variant. China is currently seeing case numbers that it hasn’t experienced since the early days of the pandemic.

Parts of Shanghai on the eastern side of the Huangpu River — which divides the city roughly down the center — will be under lockdown between Monday and Friday, according to local officials.

Western parts of Shanghai will undergo a similar lockdown protocol starting on April 1.

The Guardian reported that Shanghai officials are also implementing massive testing protocols.

Shanghai, China’s largest city, consisting of 25 million people, has recently become the hot spot for a nationwide outbreak of COVID that began in early March.

Chinese President Xi Jinping, earlier this month, urged officials in the Chinese Communist Party to “minimize the impact” of the virus on the Chinese economy as authorities work to uphold the country’s extremely aggressive “zero-COVID policy.”

On Monday, the Chinese stock exchange opened lower than expected, with the country’s benchmark CSI 300 index — analogous to the DOW Jones Industrial Average — falling as much as 2% during morning trading hours.

The government ruled out shutting down Shanghai entirely on Saturday, citing the potential damage it could cause the Chinese economy, and opted instead to implement the phased east-west lockdown approach.

On Sunday, a record 3,450 asymptomatic cases were reported in Shanghai, which accounted for nearly 70% of the nationwide total. Shanghai city officials announced 50 symptomatic cases on Monday.

The Chinese National Health Commission announced on Monday that there were 5,134 new asymptomatic cases nationally, with 1,219 new infections confirmed to be from Shanghai.

Currently, in the eastern parts of Shanghai, residents are confined to their homes. The city directed health care workers to visit each residence and conduct rapid COVID tests, with some workers arriving as early as 7 a.m. Monday morning.

In a Sunday public notice, the Shanghai government said that the two-part lockdown was being implemented “to curb the spread of the epidemic, ensure the safety and health of the people” and root out cases of infection “as soon as possible.”

The city’s eastern half will be under lockdown until April 1, at which point its western half will undergo lockdown until April 5.

Residents are being compelled to stay indoors during these lockdowns, and all businesses, employees, and government personnel who are not involved in the supply of essential services are required to work from home.

Individuals who are responsible for providing vital services such as gas, electricity, transport, sanitation, and food delivery do not have to adhere to the stay-at-home order.

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'Significantly more contagious' COVID-19 variant from UK has hit the US



A variant of COVID-19 spreading through the United Kingdom is now in America, as confirmed by Colorado Gov. Jared Polis (D) who announced Tuesday that his state has discovered its first case of the "significantly more contagious" virus.

What are the details?

Polis' office issued a notice saying that a man in his 20s tested positive for the B.1.1.7. variant to COVID-19, pointing out that the individual "is currently in isolation in Elbert County and has no travel history."

The governor said in a statement, "There is a lot we don't know about this new COVID-19 variant, but scientists in the United Kingdom are warning the world that it is significantly more contagious."

Today we discovered Colorado’s first case of the COVID-19 variant B.1.1.7, the same variant discovered in the UK.… https://t.co/aGSz6nczox
— Governor Jared Polis (@Governor Jared Polis)1609277126.0

According to The Daily Mail, the B.1.1.7. mutation is possibly as much as 70% "more infectious and more of a concern for children," and has been detected in roughly 60% of the recent COVID-19 cases in London.

But the The Washington Post reported:

Although the U.K. variant appears more contagious, it is not leading to higher rates of hospitalizations or deaths, according to a report from Public Health England, a government agency. Nor is there any sign that people who were infected months ago with the coronavirus are more likely to be reinfected if exposed to the variant, according to the report. All available evidence indicates that vaccines, and immunity built up in the population, should be protective against this variant.

Centers for Disease Control and Prevention spokeswoman Belsie González said in an email to CBS News that the agency "is aware of Colorado's report of the first U.S. case associated with the U.K. variant of COVID-19."

González noted, "In addition to the reported case in Colorado, we expect that there will be additional cases that are likely to be detected in the coming days."