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The European Medicines Agency (EMA) announced today its safety committee (PRAC) concluded 'that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).
The PRAC noted that the blood clots occurred in veins in the brain (cerebral venous sinus thrombosis) and the abdomen (splanchnic vein thrombosis) and in arteries, together with low levels of blood platelets and sometimes bleeding.
Furthermore, the 'EMA confirmed the overall benefit-risk of Vaxzevira vaccination remains positive.'
In reaching its conclusion on April 7, 2021, the PRAC considered all currently available evidence, including the advice from an ad hoc expert group.
The EMA reminds healthcare professionals and people receiving the vaccine to remain aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within 2 weeks of vaccination. So far, most of the cases reported have occurred in women under 60 years of age within 2 weeks of vaccination. Based on the currently available evidence, specific risk factors have not been confirmed.
People who have received the Vaxzevria vaccine should seek medical assistance immediately if they develop symptoms of this combination of blood clots and low blood platelets.
According to the EMA, one plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one sometimes seen in patients treated with heparin (heparin-induced thrombocytopenia, HIT). The PRAC has requested new studies and amendments to ongoing ones to provide more information and take any further actions.
The JAMA Network Open published a human papillomavirus (HPV) vaccine study on April 5, 2021, that found women who received the 9-valent human papillomavirus (9vHPV) vaccine during early pregnancy did not experience an increase in miscarriages or adverse birth outcomes.
And among live births, 9vHPV vaccine exposures during or around the time of pregnancy were not associated with adverse birth outcomes.
This cohort study analyzed data from seven participating health systems in the Vaccine Safety Datalink. The cohort comprised pregnancies among women aged 12 to 28 years that ended between October 26, 2015, and November 15, 2018. Singleton pregnancies that ended in a live birth, stillbirth, or SAB were included.
The data used included more than 800 live births with during-pregnancy or peripregnancy 9vHPV vaccine exposures and nearly 700 live births with follow-up to evaluate for congenital disabilities.
These researchers concluded by saying, 'This study found that 9vHPV vaccine exposures during or around the time of pregnancy were uncommon and not associated with spontaneous abortions or selected adverse birth outcomes.'
'Given the continual need for catch-up 9vHPV vaccination in women up to age 26 years, along with the expanded use of 9vHPV vaccination in women up to age 45 years, the findings from this study can inform counseling after inadvertent 9vHPV vaccine exposures during or around the time of pregnancy.' Note: This study's sample size was limited.
A list of approved HPV vaccines is rendered on this webpage.
This study was funded by a contract (200-2012-53526-0006) with the CDC. Dr. Sheth was supported in part by K07CA230234 from the National Cancer Institute of the National Institutes of Health. No industry conflicts of interest were disclosed.
The Olympic Flame is scheduled to go through the Osaka prefecture in Japan on April 13, 2021, but Governor Yoshimura said it would be "inappropriate" to hold it on public roads amid fears over large gatherings that could spread the (SARS-COV-2) virus,' reported Kyodo News.
"Today, we asked people in the whole of Osaka to refrain from engaging in unnecessary, non-essential outings," Yoshimura informed Reuters.
The decision to cancel the Olympic event across the Osaka Prefecture came as it confirmed a record 878 additional COVID-19 cases on April 7, 2021.
Toshiro Muto, CEO of the Tokyo Games organizing committee, announced Olympic torchbearers would run at the Expo '70 Commemorative Park in the city of Suita instead of public roads in Osaka.
The US Department of State recently issued a Level 3 Travel Advisory on March 29, 2021, saying 'Reconsider travel to Japan due to COVID-19, as the disease is still a serious concern in Tokyo and across many areas of Japan, and restrictions on entry remain in effect.'
Visit the US Embassy's COVID-19 page for more information on COVID-19 in Japan.
Texas Governor Greg Abbott issued an Executive Order on April 6, 2021, prohibiting state agencies or political subdivisions in Texas from creating a "vaccine passport" requirement or otherwise conditioning receipt of services on an individual’s COVID-19 vaccination status.
The new Order also prohibits organizations receiving public funds from requiring consumers to provide documentation of vaccine status in order to receive any service or enter any place.
"Texans are returning to normal life as more people get the safe and effective COVID-19 vaccine. But, as I've said all along, these vaccines are always voluntary and never forced," said Governor Abbott in a related press statement.
"Government should not require any Texan to show proof of vaccination and reveal private health information to go about their daily lives. That is why I have issued an Executive Order that prohibits government-mandated vaccine passports in Texas."
"We will continue to vaccinate more Texans and protect public health — and we will do so without treading on Texans' personal freedoms."
As of March 29, 2021, anyone age 16 and older became eligible to receive a COVID-19 vaccine in Texas.
The new Texas Vaccine Scheduler helps Texans get scheduled for a COVID-19 vaccine at clinics hosted by participating Texas public health entities. Register online at GetTheVaccine.dshs.texas.gov.
Public-health officials must strike a “delicate balance” when communicating risks of side effects following vaccination. An adverse event would be directly linked to a vaccine using a specific lab test in ideal situations.
But these kinds of tests aren’t possible for most adverse events, either because there aren’t specific biomarkers to test for or because such tests are impractical, reported the journal Nature on April 1, 2021.
At least initially, the events are only linked by their timing: a person receives a vaccine and then experiences the side effect at some point afterward. This makes it particularly challenging to prove whether the vaccine actually caused the adverse event.
To address this issue, the US government launched in 1990 the Vaccine Adverse Event Reporting System (VAERS) is a national early warning system to detect possible safety problems in U.S.-licensed vaccines. VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination. Anyone can report an adverse event to VAERS.
An important note from the U.S. HHS says, 'If you are experiencing a medical emergency, seek immediate assistance from a healthcare provider or call 9-1-1. The U.S. CDC and FDA do not provide individual medical treatment, advice, or diagnosis. If you need individual medical or health care advice, consult a qualified healthcare provider.'
The US Centers for Disease Control and Prevention (CDC) issued several Level 4 Travel Alerts regarding the ongoing COVID-19 pandemic. As of April 5, 2021, the CDC's High-Level Alerts state, 'Travelers should avoid all travel to these countries.'
The list of countries includes, but is not limited to, Argentina, Belgium, Bermuda, Brazil, Canada, Costa Rica, France, Greece, and many others.
The CDC stated 'Because of the current situation, even fully vaccinated travelers may be at risk for getting and spreading COVID-19 variants and should avoid all travel to these countries. If you must travel, get fully vaccinated before travel.'
There are three experimental COVID-19 vaccines authorized in the USA, and globally, there are nine other COVID-19 vaccines currently available worldwide.
Furthermore, check with your destination's Office of Foreign Affairs or Ministry of Health or the US Department of State, Bureau of Consular Affairs, Country Information page for details about entry requirements and restrictions for arriving travelers.
Additionally, returning to the USA has new requirements.
All air passengers coming to the USA, including U.S. citizens and fully vaccinated people, are required to have a negative COVID-19 test result in no more than 3 days before travel or documentation of recovery from COVID-19 in the past 3 months before they board a flight to the USA, says the CDC.
And do not travel if you were exposed to COVID-19, you are sick, you test positive for COVID-19, or you are waiting for the results of a COVID-19 test. Moreover, don’t travel with someone who is sick, says the CDC.
The US Centers for Disease Control and Prevention (CDC) issued a Level 4 Travel Alert on April 5, 2021, for the British Island territory Bermuda.
The CDC's High-Level Alert states, 'Travelers should avoid all travel to Bermuda because of the ongoing COVID-19 pandemic.'
'Because of the current situation in Bermuda, even fully vaccinated travelers may be at risk for getting and spreading COVID-19 variants and should avoid all travel to Bermuda. If you must travel to Bermuda, get fully vaccinated before travel.'
Furthermore, returning to the USA have new requirements.
All air passengers coming to the USA, including U.S. citizens and fully vaccinated people, are required to have a negative COVID-19 test result in no more than 3 days before travel or documentation of recovery from COVID-19 in the past 3 months before they board a flight to the USA, says the CDC.
And do not travel if you were exposed to COVID-19, you are sick, you test positive for COVID-19, or you are waiting for the results of a COVID-19 test. Moreover, don’t travel with someone who is sick, says the CDC.
There are three experimental COVID-19 vaccines authorized in the USA, and globally, there are nine other vaccines currently available.
Hawaii Governor David Ige approved Kauai Mayor Derek Kawakami’s request to rejoin the Safe Travels pre-travel testing program effective April 5, 2021. Visitors and residents traveling to Kauai have several options under the current COVID-19 emergency rules, which are posted at this link.
Currently, there are Hawaii Travel Restrictions in effect for all the major Hawaiian Islands, including the islands of Oahu, Kauai, Maui, Hawaii, Molokai, and Lanai.
There is a 10-day quarantine restriction for all in-bound visitors to the Hawaiian Islands. However, there is a pre-travel testing option that will allow travelers an alternative, allowing them to bypass Hawaii's quarantine restrictions, as long as they bring along proof of a negative COVID-19 test from a state-approved trusted lab testing partner.
Here are Quick Facts about bypassing quarantine in your travel to Hawai‘i and its counties.
The U.S. Centers for Disease Control and Prevention (CDC) revised guidelines published on April 2, 2021, do not impact or change Hawaii's travel rules and restrictions, stated Hawaii Guide.
And, proof of COVID-19 vaccination is not a recognized exemption to the Hawaii travel quarantine.
However, the CDC says 'fully vaccinated people can travel within the USA and do not need COVID-19 testing or post-travel self-quarantine as long as they continue to take COVID-19 precautions while traveling – wearing a mask, avoiding crowds, socially distancing, and washing hands frequently.'
CDC Director Dr. Rochelle Walensky commented on April 2, 2021, “We continue to encourage every American to get vaccinated as soon as it’s their turn, so we can begin to take steps back to our everyday lives safely. Vaccines can help us return to the things we love about life, so we encourage every American to get vaccinated as soon as they have the opportunity.”
