Pfizer wants India to order COVID-19 vaccine before pursuing approval

Pfizer was the first company to seek emergency-use authorisation (EUA) for a COVID-19 vaccine in India, but the government this month approved two much cheaper shots – one from Oxford University/AstraZeneca and another developed at home by Bharat Biotech with the Indian Council of Medical Research.

India’s Central Drugs Standard Control Organisation (CDSCO) says Pfizer officials failed to turn up to meetings after the company’s application was made in early December. The regulator has also declined to accept the company’s request for approval without a small local trial on the vaccine’s safety and immunogenicity for Indians, Reuters has reported.

Keep reading

Biden signs executive order seeking the feasibility of implementing ‘certificates of vaccination’ for international travel

President Joe Biden signed an executive order on Thursday which may be the precursor to requiring proof of vaccination for air travel.

The executive order was entitled “Promoting COVID-19 Safety in Domestic and International Travel.” Section 5 ‘International Travel’ subsection ‘e’ the order read:

“International Certificates of Vaccination or Prophylaxis.  Consistent with applicable law, the Secretary of State, the Secretary of HHS, and the Secretary of Homeland Security (including through the Administrator of the TSA), in coordination with any relevant international organizations, shall assess the feasibility of linking COVID-19 vaccination to International Certificates of Vaccination or Prophylaxis (ICVP) and producing electronic versions of ICVPs.”

The order also called for “agencies may impose additional public health measures for domestic travel.”

The order also mandates masks on airplanes, trains, ferries, ships, bus services and inside airports.

Keep reading

California halts injections of Moderna Covid vaccine batch due to ‘higher-than-usual number of adverse events’

California health officials are asking vaccine providers to stop administering a batch of Moderna’s Covid-19 jab, after an unusually high number of adverse reactions were linked to the drug.

Doses from Moderna Lot 041L20A are suspected of causing a “higher-than-usual number of adverse events” and should be shelved until a proper investigation can be conducted, the California Department of Public Health said on Sunday. 

State epidemiologist Dr. Erica S. Pan said in a statement that “fewer than 10 individuals” suffered “a possible severe allergic reaction” and required medical attention over the past 24 hours after being injected with the specific batch of vaccine. All of the incidents appear to have occurred at a single community clinic that was administering the lot. The site reportedly closed for several hours after the string of adverse reactions occurred, before switching to a different batch of the drug.

Keep reading

The Risks of Rushing a COVID-19 Vaccine

Telescoping testing timelines and approvals may expose all of us to unnecessary dangers related to the vaccine. While preclinical trials to evaluate the potential safety and efficacy of vaccine candidates are likely to include tens of thousands of patients, it is still unclear whether that number will be large enough and a trial will last long enough to evaluate safety for a drug that would be administered to so many. The US alone plans to vaccinate hundreds of millions of people with the first successful candidate. One serious adverse event per thousand of a vaccine given to 100 million people means harm to 100,000 otherwise healthy people.

Aside from questions of safety that attend any vaccine, there are good reasons to be especially cautious for COVID-19. Some vaccines worsen the consequences of infection rather than protect, a phenomenon called antibody-dependent enhancement (ADE). ADE has been observed in previous attempts to develop coronavirus vaccines. To add to the concern, antibodies typical of ADE are present in the blood of some COVID-19 patients. Such concerns are real. As recently as 2016, Dengavxia, intended to protect children from the dengue virus, increased hospitalizations for children who received the vaccine.

Keep reading

55 Americans Have Died Following COVID Vaccination, Norway Deaths Rise To 29

As Bloomberg reports, this adds six to the number of known fatalities in Norway, and also lowers the age group thought to be affected from 80.

Until Friday, Pfizer/BioNTech was the only vaccine available in Norway, and “all deaths are thus linked to this vaccine,” the Norwegian Medicines Agency said in a written response to Bloomberg on Saturday.

“There are 13 deaths that have been assessed, and we are aware of another 16 deaths that are currently being assessed,” the agency said.

All the reported deaths related to “elderly people with serious basic disorders,” it said.

“Most people have experienced the expected side effects of the vaccine, such as nausea and vomiting, fever, local reactions at the injection site, and worsening of their underlying condition.”

Norway’s experience has prompted the country to suggest that Covid-19 vaccines may be too risky for the very old and terminally ill… the exact group that ‘the science’ shows are actually at risk from this virus.

Pfizer and BioNTech are working with the Norwegian regulator to investigate the deaths in Norway, Pfizer said in an e-mailed statement. The agency found that “the number of incidents so far is not alarming, and in line with expectations,” Pfizer said.

However, it’s not just Norway as The Epoch Times’ Zachary Stieber reports that fifty-five people in the United States have died after receiving a COVID-19 vaccine, according to reports submitted to a federal system.

Deaths have occurred among people receiving both the Moderna and the Pfizer-BioNTech vaccines, according to the reports.

Keep reading

23 die in Norway after receiving Pfizer COVID-19 vaccine: officials

Twenty-three people died in Norway within days of receiving their first dose of the Pfizer COVID-19 vaccine, with 13 of those deaths — all nursing home patients — apparently related to the side effects of the shots, health officials said.

Common reactions to the vaccine, including fever and nausea, “may have contributed to a fatal outcome in some frail patients,” Sigurd Hortemo, chief physician at the Norwegian Medicines Agency, said in a Friday statement

All 13 were nursing home patients and at least 80 years old. While officials aren’t expressing serious concern, they are adjusting their guidance on who should receive the vaccine. 

Keep reading

Microsoft, Cigna form coalition for digital records of COVID-19 vaccination

Microsoft Corp, health insurer Cigna Corp and Mayo Clinic are part of a coalition pushing for digital records of people who get vaccinated against COVID-19.

A key aim of the project, called Vaccination Credential Initiative, is to help people store encrypted digital copies of their immunization records in a digital wallet of their choice, the companies said in a joint statement on Thursday.

These records could eventually be used, with an individual’s consent, by colleges that are trying to re-open or even for entry into concerts in the future, Joan Harvey, an executive at Cigna unit Evernorth told Reuters.

Keep reading

A ‘healthy’ doctor died two weeks after getting a COVID-19 vaccine; CDC is investigating why

Two weeks after getting a first dose of a Pfizer COVID-19 vaccine, a 56-year-old doctor in South Florida died this week, possibly the nation’s first death linked to the vaccine.

Health officials from Florida and the Centers for Disease Control and Prevention are investigating what role, if any, the vaccine played in the death of Dr. Gregory Michael, a Miami-Beach obstetrician who, his family says, was in otherwise good health.

Michael received his first dose of Pfizer’s COVID-19 vaccine on Dec. 18 at Mount Sinai Medical Center, according to a Facebook post from his wife, Heidi Neckelmann.

Three days later, small spots began to appear on his feet and hands and he went to the emergency room at Mount Sinai, where he has worked in private practice for 15 years, according to his personal website.

His blood count was far below normal ranges, according to Neckelmann, and he was admitted to the intensive care unit.

For two weeks, she said, doctors tried to raise Michael’s platelet count. “Experts from all over the country were involved in his care,” she wrote. “No matter what they did, the platelets count refused to go up.”

She wrote that Michael was “conscious and energetic” through the process. But just days before a last resort surgery, he suffered a stroke and died.

Neckelmann did not respond to calls and emails Thursday seeking comment.

Darren Caprara, director of operations at the Miami-Dade medical examiner’s office, said Michael died sometime between the night of Jan. 3 and the early morning of Jan. 4.

Keep reading